KDOQI Guidelines for Dialysis, Access and anemia management

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KDOQI Guidelines for Dialysis, Access and anemia management

  1. 1. K/DOQI Update 2000 NKF K/DOQI GUIDELINES 2000 NKF-K/DOQI Clinical Practice GuidelinesGeneral AcknowledgementsNKF-DOQI Steering CommitteeK/DOQI Support GroupK/DOQI Advisory BoardK/DOQI Co-Chairs and Work Groups MembershipForewordDisclaimerI. NKF-K/DOQI CLINICAL PRACTICE GUIDELINES FOR HEMODIALYSIS ADEQUACY:UPDATE 2000Acronyms and AbbreviationsIntroductionI. Measurement of Hemodialysis AdequacyGuideline 1: Regular Measurement of the Delivered Dose of HemodialysisGuideline 2: Method of Measurement of Delivered Dose of HemodialysisGuideline 3: Uniformity of Method of MeasurementII. Hemodialysis DoseGuideline 4: Minimum Delivered Dose of HemodialysisGuideline 5: Prescribed Dose of HemodialysisGuideline 6: Frequency of Measurement of Hemodialysis AdequacyIII. Blood Urea Nitrogen (BUN) SamplingGuideline 7: Blood Urea Nitrogen (BUN) SamplingGuideline 8: Acceptable Methods for BUN SamplingGuideline 9: Standardization of BUN Sampling ProcedureIV. Hemodialyzer Reprocessing and ReuseGuideline 10: Use of the Association for the Advancement of Medical Instrumentation (AAMI) Standards andRecommended Practices for Hemodialyzer ReprocessingGuideline 11: Baseline Measurement of Total Cell VolumeGuideline 12: Monitoring Total Cell VolumeGuideline 13: Minimum Required Total Cell Volume http://www.kidney.org/professionals/doqi/guidelines/doqi_uptoc.html (1 of 6) [05/25/2001 4:48:32 PM]
  2. 2. K/DOQI Update 2000V. Hemodialysis Dose TroubleshootingGuideline 14: Inadequate Delivery of HemodialysisVI. Maximizing Patient Adherence to the Hemodialysis PrescriptionGuideline 15: Optimizing Patient Comfort and AdherenceGuideline 16: Strategies to Minimize Hypotensive SymptomsVII. ReferencesVIII. AppendicesA: RPA Guideline Ordering InformationB: Kinetic Determination of the Urea Distribution VolumeC: Anthropometric Determination of the Urea Distribution VolumeD: Contribution of Residual Kidney Function on Clearance With Thrice Weekly Dialysis TherapyE: Detailed Error Analysis for Deficiencies in Delivered Kt/V or URRF: Performance of Hydraulic Compression Test During HemodialysisIX. Biographical Sketches of the NKF-K/DOQI Hemodialysis Adequacy Work Group MembersII. NKF-K/DOQI CLINICAL PRACTICE GUIDELINES FOR PERITONEAL DIALYSIS ADEQUACY:UPDATE 2000Acronyms and AbbreviationsIntroductionI. Initiation of DialysisGuideline 1: When to Initiate Dialysis Kt/Vurea CriterionGuideline 2: Indications for Renal Replacement TherapyII. Measures of Peritoneal Dialysis DoseGuideline 3: Frequency of Delivered PD Dose and Total Solute Clearance Measurement Within Six Months ofInitiationGuideline 4: Measures of PD Dose and Total Solute ClearanceGuideline 5: Frequency of Measurement of Kt/Vurea, Total CCr, PNA, and Total Creatinine AppearanceGuideline 6: Assessing Residual Kidney FunctionGuideline 7: PD Dose TroubleshootingIII. Measurement of Peritoneal Dialysis DoseGuideline 8: Reproducibility of MeasurementGuideline 9: Estimating Total Body Water and Body Surface AreaGuideline 10: Timing of MeasurementGuideline 11: Dialysate and Urine CollectionsIV. Assessment of Nutritional Status Specifically as It Relates to Peritoneal DialysisGuideline 12: Assessment of Nutritional StatusGuideline 13: Determining Fat-Free, Edema-Free Body MassGuideline 14: Use of the Modified Borah Equation to Assess Nutritional Status of Pediatric PD PatientsV. Adequate Dose of Peritoneal DialysisGuideline 15: Weekly Dose of CAPD http://www.kidney.org/professionals/doqi/guidelines/doqi_uptoc.html (2 of 6) [05/25/2001 4:48:32 PM]
  3. 3. K/DOQI Update 2000Guideline 16: Weekly Dose of NIPD and CCPDGuideline 17: PD Dose in SubpopulationsGuideline 18: Use of Empiric and Computer Modeling of PD DoseVI. Strategies for Increasing the Likelihood of Achieving the Prescribed Dose of Peritoneal DialysisGuideline 19: Identify and Correct Patient-Related Failure to Achieve Prescribed PD DoseGuideline 20: Identify and Correct Staff-Related Failure to Achieve Prescribed PD DoseVII. Clinical Outcome Goals for Adequate Peritoneal DialysisGuideline 21: Measurement of PD Patient SurvivalGuideline 22: Measurement of PD Technique SurvivalGuideline 23: Measurement of HospitalizationsGuideline 24: Measurement of Patient-Based Assessment of Quality of LifeGuideline 25: Measurement of School Attendance, Growth, and Developmental Progress in Pediatric PD PatientsGuideline 26: Measurement of Albumin Concentration in PD PatientsGuideline 27: Measurement of Hemoglobin/Hematocrit in PD PatientsGuideline 28: Measurement of Normalized PNA in PD PatientsVIII. Suitable Patients for Peritoneal DialysisGuideline 29: Indications for PDGuideline 30: Absolute Contraindications for PDGuideline 31: Relative Contraindications for PDGuideline 32: Indications for Switching from PD to HDIX. ReferencesX. AppendicesA: Detailed Rationale for Guideline 1B.C: Detailed Rationale for Guideline 6D: Detailed Rationale for Guideline 8E: Detailed Rationale for Guideline 9F: Detailed Rationale for Guideline 12G: Detailed Rationale for Guideline 15H: Detailed Rationale for Guideline 19XI. Biographical Sketches of the NKF-K/DOQI Peritoneal Dialysis Adequacy Work Group MembersIII. NKF-K/DOQI CLINICAL PRACTICE GUIDELINES FOR VASCULAR ACCESS: UPDATE 2000Acronyms and AbbreviationsIntroductionI. Patient Evaluation Prior to Access PlacementGuideline 1: Patient History and Physical Examination Prior to Permanent Access SelectionGuideline 2: Diagnostic Evaluation Prior to Permanent Access SelectionGuideline 3: Selection of Permanent Vascular Access and Order of Preference for Placement of AV FistulaeGuideline 4: Type and Location of Dialysis AV Graft Placement http://www.kidney.org/professionals/doqi/guidelines/doqi_uptoc.html (3 of 6) [05/25/2001 4:48:32 PM]
  4. 4. K/DOQI Update 2000Guideline 5: Type and Location of Tunneled Cuffed Catheter PlacementGuideline 6: Acute Hemodialysis Vascular Access—Noncuffed CathetersGuideline 7: Preservation of Veins for AV AccessGuideline 8: Timing of Access PlacementGuideline 9: Access MaturationII. Monitoring, Surveillance, and Diagnostic TestingGuideline 10: Definition of TermsGuideline 11: Monitoring Primary AV Fistulae for StenosisGuideline 12: Recirculation Methodology, Limits, Evaluation, and Follow-UpIII. Prevention of Complications: InfectionGuideline 13: Infection Control MeasuresGuideline 14: Skin Preparation Technique for Permanent AV AccessesGuideline 15: Catheter Care and Accessing the PatientÌs CirculationIV. Management of Complications: When to InterveneGuideline 16: Managing Potential Ischemia in a Limb Bearing an AV AccessGuideline 17: When to Intervene—Dialysis AV Grafts for Venous Stenosis, Infection, Graft Degeneration, andPseudoaneurysm FormationGuideline 18: When to Intervene—Primary AV FistulaeV. Management of Complications: Optimal Approaches for Treating ComplicationsGuideline 19: Treatment of Stenosis Without Thrombosis in Dialysis AV Grafts and Primary AV FistulaeGuideline 20: Treatment of Central Vein StenosisGuideline 21: Treatment of Thrombosis and Associated Stenosis in Dialysis AV GraftsGuideline 22: Treatment of Thrombosis in Primary AV FistulaeGuideline 23: Treatment of Tunneled Cuffed Catheter Dysfunction|Guideline 24: Treatment of Infection of Dialysis AV GraftsGuideline 25: Treatment of Infection of Primary AV FistulaeGuideline 26: Treatment of Infection of Tunneled Cuffed CathetersGuideline 27: Treatment of Pseudoaneurysm of Dialysis AV GraftsGuideline 28: Aneurysm of Primary AV FistulaeVI. Potential Quality of Care StandardsGuideline 29: Goals of Access Placement—Maximizing Primary AV FistulaeGuideline 30: Goals of Access Placement—Use of Catheters for Chronic DialysisGuideline 31: Center-Specific Thrombosis RateGuideline 32: Infection RateGuideline 33: Primary Access Failure Rate—AV GraftsGuideline 34: Primary Access Failure Rate—Tunneled Cuffed CathetersGuideline 35: Primary Access Failure—Native AV FistulaeGuideline 36: Cumulative Patency Rate of Dialysis AV GraftsGuideline 37: Cumulative Patency Rate of Tunneled Cuffed CathetersGuideline 38: Cumulative Patency Rate of Primary AV FistulaeVII. ReferencesVIII. Biographical Sketches of the NKF-K/DOQI Vascular Access Work Group Members http://www.kidney.org/professionals/doqi/guidelines/doqi_uptoc.html (4 of 6) [05/25/2001 4:48:32 PM]
  5. 5. K/DOQI Update 2000IV. NKF-K/DOQI CLINICAL PRACTICE GUIDELINES FOR ANEMIA OF CHRONIC KIDNEY DISEASE:UPDATE 2000Acronyms and AbbreviationsIntroductionI. Anemia Work-UpGuideline 1: When to Initiate the Work-Up of AnemiaGuideline 2: Anemia EvaluationGuideline 3: Erythropoietin DeficiencyII. Target Hemoglobin/HematocritGuideline 4: Target Hemoglobin/Hematocrit for Epoetin TherapyIII. Iron SupportGuideline 5: Assessment of Iron StatusGuideline 6: Target Iron LevelGuideline 7: Monitoring Iron StatusGuideline 8: Administration of Supplemental IronGuideline 9: Administration of a Test Dose of IV IronGuideline 10: Oral Iron TherapyIV. Administration of EpoetinGuideline 11: Route of Administration of EpoetinGuideline 12: Initial Epoetin AdministrationGuideline 13: Switching From Intravenous to Subcutaneous EpoetinGuideline 14: Strategies for Initiating and Converting to Subcutaneous Epoetin AdministrationGuideline 15: Monitoring of Hemoglobin/Hematocrit During Epoetin TherapyGuideline 16: Titration of Epoetin DosageGuideline 17: Inability to Tolerate Subcutaneous Epoetin; IV Epoetin DoseGuideline 18: Intraperitoneal Epoetin AdministrationGuideline 19: Epoetin Dosage Perioperatively or During Intercurrent IllnessV. Inadequate Epoetin ResponseGuideline 20: Causes for Inadequate Response to EpoetinGuideline 21: When to Obtain a Hematology ConsultationGuideline 22: Epoetin-Resistant PatientsVI. Role of Red Blood Cell TransfusionsGuideline 23: Red Blood Cell Transfusions in Patients With Chronic Renal FailureVII. Possible Adverse Effects Related to Epoetin TherapyGuideline 24: Possible Adverse Effects Related to Epoetin Therapy: HypertensionGuideline 25: Possible Adverse Effects Related to Epoetin Therapy: SeizuresGuideline 26: Possible Adverse Effects Related to Epoetin Therapy: Increased Clotting TendencyGuideline 27: Possible Adverse Effects Related to Epoetin Therapy: Hyperkalemia http://www.kidney.org/professionals/doqi/guidelines/doqi_uptoc.html (5 of 6) [05/25/2001 4:48:32 PM]
  6. 6. K/DOQI Update 2000VIII. EndnotesIX. ReferencesX. Biographical Sketches of the NKF-K/DOQI Anemia Work Group Members © 2001 National Kidney Foundation, Inc web version created by cyberNephrologyTM and The Nephron Information Center http://www.kidney.org/professionals/doqi/guidelines/doqi_uptoc.html (6 of 6) [05/25/2001 4:48:32 PM]
  7. 7. K/DOQI Update 2000 NKF K/DOQI GUIDELINES 2000 EXECUTIVE SUMMARY - K/DOQI CLINICAL PRACTICE GUIDELINESIntroduction - Continuous Quality Improvement: DOQI Becomes K/DOQI and IsUpdatedHemodialysis AdequacyPeritoneal Dialysis AdequacyVascular AccessTreatment of Anemia of Chronic Kidney DiseaseIntroduction - Continuous Quality Improvement: DOQI Becomes K/DOQI and IsUpdatedGarabed Eknoyan, MD, Nathan W. Levin, MD, Joseph W. Eschbach, MD, Thomas A. Golper, MD,William F. Owen, Jr, MD, Steven Schwab, MD and Earl P. Steinberg, MD, MPPFrom the Baylor College of Medicine, Houston, TX; the Renal Research Institute, New York, NY; Beth Israel Hospital Center, Boston, MA;Minor & James Medical Center, Seattle, WA; Vanderbilt University, Nashville, TN; Duke University Medical Center, Durham, NC; CovanceHealth Economics and Outcomes Services Inc; and The Johns Hopkins University, Baltimore, MD.ABOUT 300,000 individuals in the United States receive some form of dialysis, which provides life-saving renalreplacement therapy for end-stage renal disease (ESRD). While significant improvement has been made in dialysistechnology, many more opportunities remain for further improvement. Publication of the National Kidney FoundationsDialysis Outcomes Quality Initiative (NKF-DOQI) Clinical Practice Guidelines in 1997 represented the firstcomprehensive effort to give evidence-based guidance to clinical care teams, thereby decreasing practice pattern variationin over 3,100 dialysis facilities in the United States. In addition, the guidelines were the first comprehensive effort todevelop concrete plans that could have a measurable impact on improving quality of life for dialysis patients.The DOQI guidelines, supported by an educational grant from Amgen, have been widely adopted in the United States andabroad and have been a stimulus for several national organizations to develop their own guidelines. The DOQI guidelineshave been translated into at least 10 languages, been the focus of numerous quality improvement activities, and served asthe basis for ESRD clinical performance measures being developed by the Health Care Financing Administration (HCFA).By definition, any set of guidelines begins to be outdated the moment a time limit is set on the literature search they willencompass. They age exponentially once they are published, as new data in the field become available. It was agreed fromthe outset of DOQI that the guidelines would be maintained as an evolving and live document, with periodic reviews of the http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (1 of 20) [05/25/2001 4:48:36 PM]
  8. 8. K/DOQI Update 2000literature and revision of the guidelines. Consequently, the four original Work Groupsadequacy of hemodialysis, adequacyof peritoneal dialysis, management of vascular access, and management of anemiawere reactivated in 1999 to review theliterature published since 1996, the end point of the time period that formed the basis of the original guidelines. Rather thanconduct an exhaustive search of the articles published since 1996, a "top-down" approach was adopted, whereby theexperts on the Work Groups scanned the literature and selected pertinent articles. These articles were subjected to externalreview, and the Work Groups selected a final list to undergo structured review. The methods cited by Steinberg et al1 andused to evaluate the quality of evidence underlying the original guidelines prior to publication were applied to the newround of selected articles to determine what revisions were required for the update. The review process was designed toaddress the following three end products in decreasing order of priority: changes in guidelines, changes in rationales, andaddition of new evidence that is supportive of existing rationales. Articles identified by the Work Group chairs as beingrelevant to any of the three types of target changes in the Guidelines were subjected to the established NKF-DOQIstructured review process to evaluate both the content and methodology of each article.The original Work Groups appointed to examine the four areas that are the focus of the Guidelines reviewed more than11,000 articles in development of the initial DOQI Guidelines (Ref 1997 public). Over 3,000 of these publications weresubjected to preliminary review, and over half this number underwent formal, structured review. In contrast, the updateprocess focused on a total of 85 articles published since 1996 and considered to be potentially relevant by the WorkGroups. Of these, 57 were subjected to structured review according to the published DOQI methods. The other 28 articles,which included review articles and articles on basic science, did not lend themselves to such reviews.As was the case with the initial Guidelines (Ref 1997 public), the current guideline updates were subjected to a three-stagereview process. They were presented first to the NKF-DOQI Steering Committee and revised in response to the commentsreceived. In the second stage, the K/DOQI Advisory Board, along with other experts in the field, provided comments. Afterconsidering these, the Work Groups produced a third draft of the guidelines. In the final stage, this draft was madeavailable for public review and comment by all interested parties, including ESRD Networks, professional and patientassociations, dialysis providers, government agencies, product manufacturers, managed care groups, and individuals. Thecomments received were reviewed and, where appropriate, incorporated in the final version of the updated guidelines.While extensive effort has gone into the guideline development process, and careful attention has been paid to detail andscientific rigor, it is absolutely essential to emphasize that these documents are guidelines, not standards or mandates. Eachrecommendation in the guidelines is accompanied by a rationale, enabling caregivers of patients with chronic kidneydisease to make informed decisions about the proper care plan for each individual patient. Variations in practice areexpected and can be appropriate. Please refer to the disclaimer statement that accompanies these guidelines for furtherdetails regarding their intended use.While the guideline update process was underway, it was decided that, with the beginning of the new millennium, theDOQI clinical practice guideline initiative should enter a new phase that would enlarge its scope to encompass thespectrum of chronic kidney disease well before the need for dialysis arises, when early intervention and preventionmeasures can delay or prevent the need for dialysis, and improve the outcomes of patients who develop end-stage disease.This expanded scope increases the opportunity to improve the outcomes of care for millions of individuals with kidneydisease rather than only the hundreds of thousands who have end-stage disease. To reflect this expansion, the reference to"Dialysis" in DOQI was changed to "Disease" and the new initiative has been renamed the Kidney Disease OutcomesQuality Initiative (K/DOQI).The methodologic process and implementation strategies that have proven so effective for NKF-DOQI have been adaptedand expanded to reflect the new mission of K/DOQI and its broadened multidisciplinary focus. Relevant material to beincluded in future K/DOQI guidelines will be translated into implementation tools appropriate not just for nephrology, butalso for other specialties likely to encounter those at risk for chronic kidney disease early in the course of illness, includingcardiology, hypertension, diabetes, family practice, pediatrics, and internal medicine.It is the tremendous contribution of the entire renal community that made the NKF-DOQI possible. But it is the membersof the Work Groups, especially the Work Group ChairsDr Joseph Eschbach, Dr Thomas Golper, Dr William Owen, and http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (2 of 20) [05/25/2001 4:48:36 PM]
  9. 9. K/DOQI Update 2000Dr Steve Schwabwho, through their innumerable hours of dedication and invaluable expertise, synthesized and producedthe guidelines. Their enthusiasm, leadership, and tireless efforts to achieve a quality product made the NKF-DOQI ClinicalPractice Guidelines what they are todaya beacon to provide guidance, direction, and vision on a diversity of issues with asingle-focused goal: make lives better by improving patient outcomes.What follows is an executive summary of the changes made in the update process and published as a supplement to theJanuary 2001 American Journal of Kidney Diseases.FOOTNOTESAddress reprint requests to Kerry Willis, PhD, National Kidney Foundation, 30 East 33rd St, New York, NY 10016.E-mail: mailto:KerryW@kidney.orgREFERENCES 1. Steinberg E, Eknoyan G, Levin N, Eschbach J, Golper T, Owen W, Schwab S: Methods used to evaluate the quality of evidence underlying the National Kidney Foundation-Dialysis Outcomes Quality Initiative Clinical Practice Guidelines: Description, findings, and implications. Am J Kidney Dis 36:1-11, 2000Hemodialysis AdequacyWilliam F. Owen, Jr, MDFrom the Baylor College of Medicine, Houston, TX; the Renal Research Institute, New York, NY; Beth Israel Hospital Center, Boston, MA;Minor & James Medical Center, Seattle, WA; Vanderbilt University, Nashville, TN; Duke University Medical Center, Durham, NC; CovanceHealth Economics and Outcomes Services Inc; and The Johns Hopkins University, Baltimore, MD.IN THE YEARS SINCE the 1993 Clinical Practice Guidelines (CPG) of the Renal Physicians Association (RPA) and the1997 NKF-DOQI guidelines recommended how the delivered dose of hemodialysis (HD) should be measured, andarticulated an evidence-based minimum acceptable dose of HD, significant improvements in the reported dialysis dosehave been observed in the United States.1-3 From 1993 to 1997, the mean urea reduction ratio (U) increased from 62.7% to68.0%.3 Improvement of a similar magnitude was observed in another national data set in which the median U increasedfrom 58.9% ± 9.8% to 69.5% ± 8.75% from 1990 to 1997, respectively.1 The most dramatic improvement in dialysis dosewas achieved by blacks, for whom a 92% increase in the number receiving a U>65% was achieved.3 In contrast, there wasonly a 59% increase in the number of whites receiving a U>65%. As a result, the racial disparity in dialysis dose hasnarrowed.4,5 Several data sets have demonstrated that the HD dose varies inversely by weight, total body water (TBW),body surface area, and body mass index, implying that inadequate use of urea kinetic modeling may be a factorcontributing to inadequate dosing.4-8 Despite this improvement, the continued observation of large percentages of patientswho are not receiving adequate HD doses suggests that continued improvement is still needed. The formal translation ofsome of the NKF-DOQI clinical practice guidelines into national clinical performance measures (CPM) may be helpful.3Moreover, the national HD adequacy CPM will provide quantitative insights into the potential impact of NKF-DOQIClinical Practice Guidelines on HD adequacy.OBJECTIVES AND PRINCIPLES FOR THE UPDATEDespite improvement in ESRD patient care, opportunities for further improvement persist. First, over 20% of the ESRDpatients in the 1998 Core Indicators Project received a Kt/V <1.2.3 Second, the Uremains the preponderant measure of HDdose in the US.3 Third, procedural problems persist with the sampling method used for obtaining the predialysis andpostdialysis blood samples to measure the blood urea nitrogen concentration (BUN).3 Because many ESRD patients still donot receive an adequate dose of hemodialysis and the literature supporting the HD adequacy guidelines has expanded, theHD Adequacy Work Group reevaluated the topics addressed in the previous guidelines. The Work Group focused itsefforts on a review of the existing clinical practice guidelines and a discussion of operational and clinical issues that may http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (3 of 20) [05/25/2001 4:48:36 PM]
  10. 10. K/DOQI Update 2000affect the acceptance and/or implementation of these guidelines. Three specific Work Group objectives were defined: (1)review the literature that has become available since 1997 and, based upon this review, develop updates and supplementsas needed; (2) identify barriers to acceptance and implementation of the CPG; and (3) develop strategies to enhanceimplementation of the guidelines.The updated HD adequacy guidelines continue not to include all topics relevant to the global concept of HD adequacy.Topics not covered include the flux of large molecular weight solutes,9-14 membrane biocompatibility,14-29 appropriatetiming for the initiation of HD,30,31 interplay between HD dose and nutrition,32-34 and the affect of HD dose and patientsquality of life and rehabilitation.35,36 Some of these topics are discussed in other K/DQOI guidelines (ie, nutrition in theClinical Practice Guidelines for Nutrition in Patients with Chronic Renal Failure; timing of the initiation of dialysis in theClinical Practice Guidelines on Peritoneal Dialysis Adequacy). The HD Work Groups focus remained on the fundamentalissue of the impact of small molecular weight solute clearance on patient mortality. As in the original, the updated ClinicalPractice Guidelines on Hemodialysis Adequacy apply to adult and pediatric hemodialysis patients who have ESRD,experience negligible kidney function (glomerular filtration rate [GFR] <5 mL/min), and receive outpatient HD three timesper week.RESULTS OF THE UPDATEComparison to the Original CPGBased on a structured identification and review of the literature since 1996, no evidence was found that resulted in theinclusion of new guideline statements. Similarly, there was no new literature that necessitated the deletion of any of theoriginal guideline statements. Only one CPG statement was modified (Guideline 16: Strategies to Minimize HypotensiveSymptoms). On the other hand, a substantial amount of new evidence in support of the rationale for the existing CPGstatements has appeared in the literature and is summarized below in the context of the individual CPG statements.GUIDELINE 1: Regular Measurement of the Delivered Dose of Hemodialysis(Evidence)The dialysis care team should routinely measure and monitor the delivered doseof hemodialysis.Since 1997, two additional large retrospective studies were published demonstrating the relationship between the dose ofHD and patient mortality.37,38GUIDELINE 2: Method of Measurement of Delivered Dose of Hemodialysis(Evidence)The delivered dose of hemodialysis in adult and pediatric patients should bemeasured using formal urea kinetic modeling (UKM), employing the single-pool,variable volume model.The evidence model supporting this statement used the following criteria: (1) comparative accuracy of alternative methodsof measuring HD dose; (2) completeness of information provided by alternative methods (eg, does the method supportcalculation of normalized protein catabolic rate [NPCR], which is equivalent to the dietary protein intake in steady-state;capacity to account for the impact of residual kidney function on the delivered dose of hemodialysis and NPCR); (3)availability of dialysis unit staff to collect blood samples properly and record information from the HD session, such as thetype of dialysis membrane used, intradialytic weight loss, blood and dialysate flows, true dialysis time; and (4) time torecord, enter, and process this information. Recognizing that a minority of providers is unable or unwilling to performUKM, one alternative method for calculating Kt/V (Kt/V natural logarithm [Ln] formula)39 and one other measurement of http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (4 of 20) [05/25/2001 4:48:36 PM]
  11. 11. K/DOQI Update 2000the delivered dose of hemodialysis (urea reduction ratio [U])40 were recommended for routine use in adults.Since 1997, a small analysis validated the second generation Kt/V Ln formula for children.39,41 Moreover, the measuredHD dose was equivalent whether using formal UKM or the Kt/V Ln formula for children,41 but the HD Adequacy WorkGroup continues to favor the use of UKM to derive the Kt/V for pediatric ESRD patients. HD doses measured by Uhavenot been validated for pediatric patients, so use of Uinstead of Kt/V may be problematic for this patient subset. Childrenhave smaller anthropometric attributes and relatively higher TBW, so they are at increased risk for significant amounts ofurea rebound.Again, the dialysate collection method was recognized as an alternative approach for quantifying the delivered HD dose.However, the HD Adequacy Work Groups decision not to support use of this technique was strengthened by recentliterature demonstrating the possibility of exaggeration of systematic collection errors.42,43 For example, a 7% error indialysate collection can result in a 20% error in the equilibrated Kt/V (Kt/Vequil). The Solute (or Urea) Removal Index,defined as the percentage of total body urea nitrogen that is removed by a dialysis treatment or direct device measurementof urea removal during an HD session, could not be evaluated by the HD Adequacy Work Group because of the lack ofexperience with their accuracy and utility.42,43 As was the case during the original Work Group deliberations, consensusagain could not be reached about the use of the duration of HD as an independent surrogate of HD dose. Some WorkGroup members felt that, independent of the HD delivered dose calculated using a single-pool or equilibrated variablevolume model of urea kinetics, the duration of HD should not be permitted to fall to less than 2.5 hours. Despite newliterature describing the relationship between blood pressure and mortality in ESRD patients,44-46 and the putative benefitsof dialyzer flux,12-16 consensus remained elusive.Dialysis time and rate of clearance (K/V) was considered extensively in the context of double-pool effects of urea removal,which can substantially reduce the accuracy of single-pool urea kinetic calculations. Some patients, whose HD dose ismeasured by the single pool model alone, are at risk for unappreciated underdelivery of HD. Although not yet achievingthe status of a clinical practice guideline (CPG) recommendation, the HD Adequacy Work Group strongly encourages theuse of Kt/Vequil measurements, especially in patients with a large K/V.47 Use of Kt/Vequil is considerably easier now thatthe Daugirdas rate formula has been validated48 by the prospective randomized controlled NIHs HEMOdialysis Study.49In a prospective analysis that compared Kt/Vequil calculated using a 30-minute postdialysis sample and Kt/Vequil calculatedusing the Daugirdas rate formula, an r value of 0.85 was observed. The Work Group still did not find literature thatdemonstrates a mortality benefit of Kt/Vequil over single-pool models of urea clearance, and so did not express a preferencefor Kt/Vequil. However, at the completion of the HEMO Study, definitive evidence will be provided of the best measure ofdialysis dose and its association with mortality and morbidity.GUIDELINE 3: Uniformity of Method of Measurement (Opinion)All patients receiving hemodialysis in the same dialysis facility should have thedelivered dose of hemodialysis measured using the same method.Minor changes were made to the rationale.GUIDELINE 4: Minimum Delivered Dose of Hemodialysis (Adults Evidence,Children Opinion)The dialysis care team should deliver a Kt/V of at least 1.2 (single-pool, variablevolume) for both adult and pediatric hemodialysis patients. For those using theU, the delivered dose should be equivalent to a Kt/V of 1.2 (ie, an average U of65%). Ucan vary substantially as a function of fluid removal, however. http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (5 of 20) [05/25/2001 4:48:36 PM]
  12. 12. K/DOQI Update 2000This clinical practice guideline statement was strengthened by a new analysis by Gotch et al37 in which severalretrospective studies of the relationship between HD dose and mortality were converted to Kt/Vequil measurements. In thelarger studies that used data from the US Renal Data System (USRDS) and Fresenius Medical Care, the mortality-HD doserelationship behaved as a 1 knot spline, ie, no further improvement in survival was observed at Kt/Vequil >1.05. Onaverage, the Kt/Vequil is 0.2 units less than the single-pool Kt/V.48,50 These analyses thus suggest that a minimum Kt/Vvalue of 1.20 is appropriate. Moreover, the paper offered an additional explanation for why some smaller studies observeda putative benefit associated with higher HD doses. If the improvement in survival for ESRD patients occurs as a stepfunction above some minimum Kt/V, increasing the dialysis dose for the population of patients will result in a decrease inmortality for the group. With a normal distribution, increasing the group mean minimizes the number of patients at risk, sothe false impression of continued benefit from higher dialysis doses is portrayed.In the revised HD Adequacy guidelines, the recommended minimum delivered dose in selected patient populations was notmodified. The Work Group scrutinized a retrospective analysis of mortality by race and gender that suggested a relativeinsensitivity of mortality to HD delivered dose in blacks.38 This counterintuitive finding seems to be a consequence of thearithmetic construction of Kt/V, in which V behaves as a biologic-based, independent outcome predictor reflecting thepatients nutritional health.38,51,52GUIDELINE 5: Prescribed Dose of Hemodialysis (Opinion)To prevent the delivered dose of hemodialysis from falling below therecommended minimum dose, the prescribed dose of hemodialysis should beKt/V 1.3. In terms of U, a Kt/V of 1.3 corresponds to an average Uof 70%, but theUcorresponding to a Kt/V of 1.3 can vary substantially as a function ofultrafiltration.Several new publications have continued to identify the disparity between prescribed and delivered HD doses,6,7,53,59 andthe fact that many of these deficiencies can be detected and corrected if a structured approach, such as is offered in theK/DOQI HD Adequacy Clinical Practice Guidelines, is employed. However, underprescription of HD remains a difficultchallenge to overcome.6,7,54 A recent survey of hemodialysis practices demonstrated that a low dialysis prescription wasone of the strongest predictors of inadequate HD dose.7 Recognizing that some dialysis care teams prefer to monitor HDdosing using Kt/Vequil, the Work Group recommends that the minimum prescribed Kt/Vequil be 1.05. In the updatedK/DOQI HD Adequacy clinical practice guidelines, a new table is provided to quantify the relationship between dialysistreatment time, single-pool Kt/V, and Kt/Vequil.GUIDELINE 6: Frequency of Measurement of Hemodialysis Adequacy (Opinion)The delivered dose of hemodialysis should be measured at least once a monthin all adult and pediatric hemodialysis patients. The frequency of measurementof the delivered dose of hemodialysis should be increased when: (1) patients arenoncompliant with their hemodialysis prescriptions (missed treatments, late fortreatments, early sign-off from hemodialysis treatments, etc), (2) frequentproblems are noted in delivery of the prescribed dose of hemodialysis (such asvariably poor blood flows, or treatment interruptions because of hypotension orangina pectoris), (3) wide variability in urea kinetic modeling results is observedin the absence of prescription changes, and (4) the hemodialysis prescription ismodified. http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (6 of 20) [05/25/2001 4:48:36 PM]
  13. 13. K/DOQI Update 2000Minor changes were made to the rationale.GUIDELINE 7: Blood Urea Nitrogen (BUN) Sampling (Evidence)Predialysis and postdialysis blood samples for measurement of BUN levels mustbe drawn at the same hemodialysis session. The same machine should be usedfor estimation of both samples. (Evidence)Strong quantitative support for this guideline statement was offered by an analysis of individual variability in measures ofHD adequacy that standardized for blood sampling technique (4.0% and 2.4% coefficient of variation for Kt/V and U,respectively).55 Most of the variation was attributable to variation in the laboratorys BUN measurement.GUIDELINE 8: Acceptable Method for BUN Sampling (Evidence)Blood samples for BUN measurement must be drawn in a particular manner.Predialysis BUN samples should be drawn immediately prior to dialysis, using atechnique that avoids dilution of the blood sample with saline or heparin.Postdialysis BUN samples should be drawn using the Slow Flow/Stop PumpTechnique that prevents sample dilution with recirculated blood and minimizesthe confounding effects of urea rebound.Minor changes were made to the rationale.GUIDELINE 9: Standardization of BUN Sampling Procedure (Opinion)Hemodialysis facilities should adopt a single BUN sampling method. If severaldifferent methods are used, the sampling method should be routinely recorded.The sampling method used for a given patient should remain consistent. Thepredialysis and postdialysis BUN samples for a given patient should beprocessed in the same batch analysis at the laboratory.Minor changes were made to the rationale.GUIDELINE 10: Use of the Association for the Advancement of MedicalInstrumentation (AAMI) Standards and Recommended Practices forHemodialyzer Reprocessing (Opinion)When hemodialyzers are reused, they should be reprocessed following theAssociation for the Advancement of Medical Instrumentation (AAMI) Standardsand Recommended Practices for reuse of hemodialyzers, with the exception ofthe AAMI guideline regarding baseline measurement of the total cell volume.The HD Adequacy Work Group was impressed that, among dialysis units that reprocess dialyzers, the median of theaverage number of reuses has increased from 9 in 1986 to 14 in 1994.56 The median of the maximum number of reportedreuses has increased from 23 to 30 over the same interval. The expanded literature on the impact of dialyzer reuse on themortality of dialysis patients was examined57 in response to previous reports of a 10% increase in death risk for patients http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (7 of 20) [05/25/2001 4:48:36 PM]
  14. 14. K/DOQI Update 2000who used hemodialyzers reprocessed in selected hemodialysis settings with the use of certain germicides.58 It isnoteworthy that the finding of increased risk of death has not been observed consistently,57 even with uniform data setextraction and risk modeling. The Work Group was concerned that this variability might be a consequence ofunappreciated, thence unadjusted for differences in HD dose. The HEMO study, however, shows virtually no effect ofreuse on urea clearance as contrasted to þ2M clearance.59 This concern was increased by the finding that hemodialyzerreprocessing can substantially affect solute clearance, and hence the delivered dialysis dose, if measured using blood sideurea clearance.59-62 In a study examining polysulfone high-flux hemodialyzers reprocessed with formaldehyde and bleach,urea clearance decreased at least 20% by 10 reuses, even though conventional AAMI dialyzer practices were followed.59GUIDELINE 11: Baseline Measurement of Total Cell Volume (Evidence)If a hollow fiber dialyzer is to be reused, the total cell volume (TCV) of thathemodialyzer should be measured prior to its first use. Batch testing and/or useof an average TCV for a group of hemodialyzers is not an acceptable practice.Minor changes were made to the rationale.GUIDELINE 12: Monitoring Total Cell Volume (Evidence)During each reprocessing, the total cell volume (TCV) of reused dialyzers shouldbe checked.A new report supports the HD Adequacy Work Groups appeal for the development of new techniques that can provide abetter indication of anticipated dialyzer performance than that provided by TCV. Using a novel dilution technique for invivo determination of fiber bundle volume (FBV), a substantial disparity was observed; volumetric TCV overestimatedFBV.62GUIDELINE 13: Minimum Required Total Cell Volume (Opinion)Dialyzers having a total cell volume (TCV) < 80% of original measured valueshould not be reused.Minor changes were made to the rationale.GUIDELINE 14: Inadequate Delivery of Hemodialysis (Opinion)If the delivered Kt/V falls below 1.2 or the Udeclines to <65% on a singledetermination, at least one of the following actions should be performed: (1)investigate potential errors in the delivery of the prescribed hemodialysis dose,(2) increase empirically the prescribed dose of hemodialysis, and/or (3) suspenduse of the reprocessed hollow fiber hemodialyzer. The impact of thesecorrective interventions should be followed by performing more frequentmeasurements of Kt/V or U.Minor changes were made to the rationale. http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (8 of 20) [05/25/2001 4:48:36 PM]
  15. 15. K/DOQI Update 2000GUIDELINE 15: Optimizing Patient Comfort and Adherence (Opinion)Without compromising the delivered dose of hemodialysis, efforts should beundertaken to modify the hemodialysis prescription to prevent the occurrence ofintradialytic symptoms that adversely affect patient comfort and adherence.A substantial amount of in literature documenting the frequency of HD noncompliance (missing, arriving late, and/orinterrupting HD treatments) and illustrating its deleterious effects has appeared since 1997. These studies validated theWork Groups concerns about patient discomfort contributing to noncompliance.7,63,64GUIDELINE 16: Strategies to Minimize Hypotensive Symptoms (Evidence)Without compromising the delivered dose of hemodialysis, efforts should beundertaken to minimize intradialytic symptoms that compromise the delivery ofadequate hemodialysis, such as hypotension and cramps. These efforts mayinclude one or more of the following: avoid excessive ultrafiltration, slow theultrafiltration rate, perform isolated ultrafiltration, increase the dialysate sodiumconcentration, switch from acetate to bicarbonate-buffered dialysate, reduce thedialysate temperature, administer midodrine predialysis, correct anemia to therange recommended by the K/DOQI Anemia Guidelines, and/or administersupplemental oxygen.Evidence of the safety and efficacy of reducing the dialysate temperature from 37ƒC to 34ƒC to 35ƒC has been extended,65so the rationale for this CPG statement has been expanded. Since the original DOQI HD Adequacy guidelines, midodrine,an oral selective ²1-adrenergic agonist, has been evaluated for treatment of symptomatic intradialytic hypotension.Midodrine has been demonstrated to minimize intradialytic hypotensive symptoms and events, to raise the lowestintradialytic blood pressure, and to decrease interventions for hypotension.66-69 When administered within 30 minutes ofthe initiation of hemodialysis, midodrine raises blood pressure by increasing peripheral vascular resistance (arteriolarvasoconstriction) and enhancing venous return and cardiac output (venular constriction).70 The drug is well tolerated andassociated with few side effects. The hemodynamic benefits of hypothermic dialysis alone, or in combination withmidodrine, were comparable across interventions.69APPENDIX C: Anthropometric Determination of the Urea Distribution VolumeThe Mellits-Cheek formulae are now included to calculate TBW for pediatric ESRD patients.71REFERENCES 1. Owen WF: Status of hemodialysis adequacy in the United States. Does it account for improved patient survival? Am J Kidney Dis 32:S39-S43, 1998 (suppl 4) 2. Port FK, Orzol SM, Held PJ, Wolfe RA: Trends in treatment and survival for hemodialysis patients in the United States. Am J Kidney Dis 32:S34-S38, 1998 (suppl 4) 3. Health Care Financing Administration: 1999 Annual Report, End Stage Renal Disease Core Indicators Project. Department of Health and Human Services, Health Care Financing Administration, Office of Clinical Standards and Quality, Baltimore, MD, December, 1999 4. Frankenfield D, McClellan WM, Helgerson SD, Lowrie EG, Rocco M, Owen WF: Relationship between urea reduction ratio, demographic characteristics, and body weight for patients in 1996 National ESRD Core Indicators Project. Am J Kidney Dis 33:584-591, 1999 http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (9 of 20) [05/25/2001 4:48:36 PM]
  16. 16. K/DOQI Update 2000 5. Owen WF, Chertow G, Lazarus JM, Lowrie EG: The dose of hemodialysis: Mortality responses by race and gender. JAMA 280:1764-8, 1998 6. Ifudu O, Mayers JD, Matthew JJ, Fowler AM, Homel P, Friedman EA: Standardized hemodialysis prescriptions promote inadequate treatment in patients with large body mass. Ann Intern Med 128:451-454, 1998 7. Sehgal A, Snow RJ, Sinder ME, Amini SB, DeOreo PB, Silver MR., Cebul RD: Barriers to adequate delivery of hemodialysis. Am J Kidney Dis 31:593-601, 1998 8. Coyne DW, Delmez J, Spence G, Windus DW: Impaired delivery of hemodialysis prescriptions: An analysis of causes and an appropach to evaluation. J Am Soc Nephrol 8:1315-1318, 1997 9. van Ypersele de Strihou, Jadoul M, Malghem J: Effect of dialysis membrane and a patients age on signs of dialysis-related amyloidosis. The Working party on Dialysis Amyloidosis. Kidney Int 39:1012-1019, 199110. Koch KM: Dialysis-related amyloidosis (clinical conference). Kidney Int 41:1416-1429, 199211. Hakim RM: Influence of high-flux biocompatible membrane on carpal tunnel syndrome and mortality. Am J Kidney Dis 32:338-343, 199812. Koda Y, Nishi S, Miyazaki S, Haginoshita S, Sakurabayashi T, Suzuki M, Sakai S, Yuasa Y, Hirasawa Y, Nishi T: Switch from conventional to high-flux membrane reduces the risk of carpal tunnel syndrome and mortality of hemodialysis patients. Kidney Int 52:1096-1101, 199713. Locatelli F, Marcelli D, Conte M, Limido A, Malberti F, Spotti D, Registro Lombardo Dialisi E Trapianto: Effect of dialysis membranes and middle molecule removal on chronic hemodialysis patient survival. Kidney Int 55:286-293, 199914. Seres DS, Strain GW, Hashim SA, et al: Improvement of plasma lipoprotein profiles during high-flux dialysis. J Am Soc Nephrol 3:1409-1415, 199315. Hakim RM, Held PJ, Stannard DC, Wolfe RA, Port FK, Daugirdas JT, Agodoa L: Effect of dialysis membranes on mortality of chronic hemodialysis patients. Kidney Int 50:566-570, 199616. Levin NW, Zasuwa G: Relationship between dialyser type and signs and symptoms. Nephrol Dial Transplant 8:S30-S39, 1993 (suppl 2)<17. Hakim RM, Breillatt J, Lazarus JM, Port FK: Complement activation and hypersensitivity reactions to dialysis membranes. N Engl J Med 311:878-882, 1984<18. Schoels M, Jahn B, Hug F, et al: Stimulation of mononuclear cells by contact with cuprophan membranes: further increase of beta 2-microglobulin synthesis by activated late complement components. Am J Kidney Dis 21:394-399, 199319. Lazarus JM, Owen WF: Role of bioincompatability in dialysis morbidity and mortality. Am J Kidney Dis 24:1019-1032, 1994 [Abstract]20. Hakim R: Clinical implications of hemodialysis membrane: Effect of chronic complement activation. Kidney Int 44:484-494, 199321. Hakim R, Fearon DT, Lazarus JM: Biocompatibility of dialysis membranes: Effects of chronic complement activation. Kidney Int 26:194-200, 198422. Himmelfarb J, Gerard NP, Hakim RM: Intradialytic modulation of granulocyte C5a receptors. J Am Soc Nephrol 2:920-926, 1997 [Abstract]23. Craddock PR, Fehr J, Dalmasso AP, et al: Hemodialysis leukopenia. Pulmonary vascular leukostasis resulting from complement activation by dialyzer cellophane membranes. J Clin Invest 59:879-888, 197724. Himmelfarb J, Lazarus J, Hakim R: Reactive oxygen species production by monocytes and polymorphonuclear leukocytes during dialysis. Am J Kidney Dis 17:271-276, 1991 [Abstract]25. Vanholder R, Ringoir S: Infectious morbidity and defects of phagocytic function in end-stage renal disease; a review (editorial). J Am Soc Nephrol 3:1541-1554, 1993 [Abstract]http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (10 of 20) [05/25/2001 4:48:36 PM]
  17. 17. K/DOQI Update 200026. Vanholder R, DellAquila R, Jacobs V, et al: Depressed phagocytosis in hemodialyzed patients: In vivo and in vitro mechanisms. Nephron 63:409-453, 199327. Vanholder R, Van Loo A, Dhondt AM, Ringoir S: The role of dialysis membranes in infection. Nephrol Dial Transplant 11:101-103, 199628. Parker TF, Wingard RL, Husni L, et al: Effect of membrane biocompatibility on nutritional parameters in chronic hemodialysis patients. Kidney Int 49:551-556, 199629. Himmelfarb J, Hakim RM: Biocompatibility and risk of infection in haemodialysis patients. Nephrol Dial Transplant 9:S138-S144, 1994 (suppl)<30. Hakim RM, Lazarus JM: Initiation of dialysis. J Am Soc Nephrol 6:1319-1328, 199531. National Kidney Foundation: NKF-DOQI Clinical Practice Guidelines for Peritoneal Dialysis Adequacy. Am J Kidney Dis 30:S69-S133, 1997 (suppl 2)32. Lindsay RM, Spanner E: A hypothesis: The protein catabolic rate is dependent upon the type and amount of treatment in dialyzed uremic patients. Am J Kidney Dis 13:S382-S389, 1989 (suppl)33. Lindsay RM, Spanner E, Heidenheim P, et al: Which comes first, Kt/V or PCRChicken or egg? Kidney Int 41:S267-S273, 1993 (suppl)<34. National Kidney Foundation: NKF-DOQI clinical practice guidelines for nutrition in chronic renal failure. Am J Kidney Dis 35:S1-S140, 2000 (suppl)35. DeOreo P: Hemodialysis patient assessed functional health status predicts continued survival, hospitalization, and dialysis-attendance compliance. Am J Kidney Dis 30:204-212, 199736. Kimmel PL, Peterson RA, Weihs KL, Simmens SJ, Alleyne S, Cruz I, Veis JH: Psychosocial factors, behavioral compliance and survival in urban hemodialysis patients. Kidney Int 54:245-254, 199837. Gotch F, Levin NW, Port FK, Wolfe RA, Uehlinger E: Clinical outcome relative to the dose of dialysis is not what you think: The fallacy of the mean. Am J Kidney Dis 30:1-15, 199738. Owen WF, Chertow G, Lazarus JM, Lowrie EG: The dose of hemodialysis: Mortality responses by race and gender. JAMA 280:1-6, 199839. Daugirdas JT: Second generation logarithmic estimates of single-pool variable volume Kt/V: An analysis of error. J Am Soc Nephrol 4:1205-1213, 199340. Owen WF, Lew NL, Liu Y, Lowrie EG, Lazarus JM: The urea reduction ratio and serum albumin concentration as predictors of mortality in patients undergoing hemodialysis. N Engl J Med 329:1001-1006, 199341. Goldstein SL, Sorof JM, Brewer E: Natural logarithmic estimates of Kt/V in the pediatric hemodialysis population. Am J Kidney Dis 33:518-522, 199942. Depner TA, Greene T, Gotch FA, Daugirdas JT, Keshaviah PR, Star RA, Hemodialysis Study Group: Imprecision of the hemodialysis dose when measured directly from urea removal. Kidney Int 55:635-647, 199943. Cheng YL, Shek CC, Wong FKM, Choi KS, Chau KF, Ing T, Li CS: Determination of the solute removal index for urea by using a partial spent dialysate collection method. Am J Kidney Dis 31:986-990, 199844. Fishbane S, Natke E, Maesaka JK: Role of volume overload in dialysis-refractory hypertension. Am J Kidney Dis 28:257-261, 199645. Rahman M, Dixit A, Donley V, Gupta S, Hanslik T, Lacson E, Ogundipe A, Weigel K, Smith MC: Factors associated with inadequate blood pressure control in hypertensive hemodialysis patients. Am J Kidney Dis 33:498-506, 199946. Sorof JM, Brewer ED, Portman RJ: Ambulatory blood pressure monitoring and interdialytic weight gain in children receiving chronic hemodialysis. Am J Kidney Dis 33:667-674, 199947. Kloppenburg WD, Stegeman CA, Hooyschuur M, Van der Ven J, De Jong PE, Huisman RM: Assessing dialysis adequacy and dietary intake in the individual patient. Kidney Int 55:1961-1969, 1999http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (11 of 20) [05/25/2001 4:48:36 PM]
  18. 18. K/DOQI Update 200048. HEMO Study Group, Daugirdas JT, Depner TA, Gotch F, Greene T, Keshaviah P, Levin NW, Schulman G: Comparison of methods to predict equilibrated Kt/V in the HEMO Pilot Study. Kidney Int 52:1395-1405, 199749. Eknoyan G, Levey AS, Beck GJ, Agodoa LY, Daugirdas JT, Kusek JW, Levin NW: The Hemodialysis (HEMO) Study: Rationale for selection of interventions. Semin Dial 9:24-33, 199650. Spiegel DM, Baker PL, Babcock S, Contiguglia R, Klein M. Hemodialysis urea rebound: The effect of increasing dialysis efficiency. Am J Kidney Dis 25:26-29, 199551. Chertow GM, Owen WF, Lazarus JM, Lew SM, Lowrie EG: The interplay of uremia and malnutrition: An hypothesis for the reverse J-shaped curve between Uand mortality. Kidney Int 56:1872-1878, 199952. Lowrie EG, Chertow G, Lazarus JM Owen WF: The mortality effect of the clearance x time product. Kidney Int 56:729-737, 199953. Coyne DW, Delmez J, Spence G, Windus DW: Impaired delivery of hemodialysis prescriptions: An analysis of causes and an approach to evaluation. J Am Soc Nephrol 8:1315-1318, 199754. Frankenfield D, McClellan WM, Helgerson SD, Lowrie EG, Rocco M, Owen WF: Relationship between urea reduction ratio, demographic characteristics, and body weight for patients in 1996 National ESRD Core Indicators Project. Am J Kidney Dis 33:584-591, 199955. Kloppenburg WD, Stegeman CA, Hooyschuur M, Van der Ven J, De Jong PE, Huisman RM: Assessing dialysis adequacy and dietary intake in the individual patient. Kidney Int 55:1961-1969, 199956. Tokars J, Alter MJ, Favero MS, Moyer LA, Miller E, Bland LA: National surveillance of dialysis associated disease in the United States, 1994. ASAIO J 42:119-129, 199657. Collins AJ, Ma JZ, Constantini EG, Everson SE: Dialysis unit and patient characteristics associated with reuse practices and mortality: 1989-1993. J Am Soc Nephrol 9:2108-2117, 199858. Feldman HI, Kinosian M, Bilker WB, Simmons C, Holmes JH, Pauly MV, Escarce JJ: Effect of dialyzer reuse on survival of patients treated with hemodialysis. JAMA 276:620-625, 199659. Murthy BVR, Sundaram S, Jaber BL, Perrella C, Meyer KB, Pereira BJG: Effect of formaldehyde/bleach reprocessing on in vivo performances of high efficiency cellulose and high flux polysulfone dialyzers. J Am Soc Nephrol 9:464-472, 199860. Cheung AK, Agodoa LY, Daugirdas JT, Depner TA, Gotch FA, Greene T, Levin NW, Leypoldt JK, Hemodialysis Study Group: Effects of hemodialyzer reuse on clearances of urea and þ2-microglobulin. J Am Soc Nephrol 10:117-127, 199961. Garred LJ, Canuad B, Flavier J-L, Poux C, Polito-Bouloux C, Mion C: Effect of reuse on dialyzer efficacy. Artif Organs 14:80-84, 199062. Krivitski M, Kislukhin VV, MacGibbon DR, Kuznetsova OA, Reasons AM, Depner TA: In vivo measurement of hemodialyzer fiber bundle volume: Theory and validation. Kidney Int 1751-1758, 199863. Bleyer AJ, Hylander B, Sudo S, Nomoto Y, de la Torre E, Chen RA, Burkart JM: An international study of patient compliance with hemodialysis. JAMA 281:1211-1213, 199964. Leggat JE, Orzol SM, Hulbert-Shearon TE, Golper TA, Jones CA, Held PJ, Port FK: Noncompliance in hemodialysis patients: Predictors and survival analysis. Am J Kidney Dis 32:139-145, 199865. Kaufman A, Morris AT, Lavarias VA, Wang Y, Leung JF, Glabman MB, Yusuf SA, Levoci AL, Polaschegg HD, Levin NW: Effects of controlled blood cooling on hemodynamic stability and urea kinetics during high efficiency hemodialysis. J Am Soc Nephrol 44:606-612, 1997<66. Fynn JJ, Mitchell MC, Caruso FS, McElligott MA: Midodrine treatment for patients with hemodialysis hypotension. Clin Nephrol 45:261-7, 199667. Cruz DN, Mahnensmith RL, Perazella MA: Intradialytic hypotension: Is midodrine beneficial in symptomatic hemodialysis patients? Am J Kidney Dis 101-107, 199668. Cruz DN, Mahnensmith RL, Brickel HM, Perazella MA: Midodrine is effective and safe therapy for intradialytichttp://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (12 of 20) [05/25/2001 4:48:36 PM]
  19. 19. K/DOQI Update 2000 hypotension over 8 months of follow-up. Clin Nephrol 101-107, 1998 69. Cruz DN, Mahnensmith RL, Brickel HM, Perazella MA: Midodrine and cool dialysate are effective therapies for symptomatic intradialytic hypotension. Am J Kidney Dis 33:920-926, 1999 70. Janvokic J, Gilden JL, Hiner BC, Kaufman H, Brown DC, Coghlan CH, Rubin M, Fouad-Tarazi FM: Neurogenic orthostatic hypotension: A double-blind, placebo-controlled study with midodrine. Am J Med 95:38-48, 1993 71. Jabs K, Warady BA: The impact of the Dialysis Outcomes Quality Initiative guidelines on the care of the pediatric end-stage renal disease patient. Adv Renal Replace Ther 6:97-106, 1999Peritoneal Dialysis AdequacyThomas Golper, MDFrom the Baylor College of Medicine, Houston, TX; the Renal Research Institute, New York, NY; Beth Israel Hospital Center, Boston, MA;Minor & James Medical Center, Seattle, WA; Vanderbilt University, Nashville, TN; Duke University Medical Center, Durham, NC; CovanceHealth Economics and Outcomes Services Inc; and The Johns Hopkins University, Baltimore, MD.IN 1999 THE PERITONEAL Dialysis (PD) Adequacy Work Group was reconstituted to include several original membersand four new members. The original members who continued were Tom Golper (chair), John Burkart (vice-chair), DavidChurchill, Cathy Firanek, Karl Nolph, Frank Gotch, Tony Tzamaloukas, and Brad Warady. New members were PeterBlake, Dinesh Chatoth, Alan Kliger, and Steve Korbet. The Workgroup made two major changes to the clinical practiceguidelines published in 1997. In addition to these major changes, there were several newly derived formulae that wereincluded, as well as clarifications and occasional corrections of other statements in the text and rationales. No newguidelines were added. What follows is a brief overview that highlights the changes, additions, clarifications, andcorrections that have been made in the update.MAJOR CHANGESNutritional Indications for the Initiation of Renal Replacement TherapyJoel Kopple and Brad Maroni, representing the Nutrition Work Group, and John Burkart and Tom Golper from the PDAdequacy Work Group formed a subgroup to reconcile differences between the recently issued Nutritional Guidelines andthe original 1997 PD Clinical Practice Guideline 2: Nutritional Indications for Dialysis. The key discrepancies were relatedto the efficacy and role of prescribed low-protein diets in slowing the progression of kidney disease, the role ofspontaneous low-protein intake due to uremia as a potential cause of malnutrition, and the ability of dialysis to reverse themalnutrition associated with progressive uremia. The subgroup rapidly reconciled the differences and both Work Groupsthen agreed to use the same clinical practice guideline. The lengthy version of the clinical practice guideline, including therelevant references, now appears in the Clinical Practice Guidelines for Nutrition in Chronic Renal Failure as Guideline 27.The same text, but without the references, appears as Guideline 2 of the updated guidelines related to PD Adequacy. Whilethe new guideline reconciles the differences between the low-protein diet proponents and those less inclined to use thatapproach, it also articulates specific criteria to follow and states clearly the interventions recommended to correct variousproblems. The new CPG is opinion based and reads as follows: "In patients with chronic kidney failure (ie, GFR <20mL/min) who are not undergoing maintenance dialysis, if protein-energy malnutrition develops or persists despite vigorousattempts to optimize protein and energy intake and there is no apparent cause for malnutrition, initiation of maintenancedialysis or a renal transplant is recommended. (Opinion)"Within the rationale, there is a particularly important statement regarding institution of protein restriction; namely that it "ismandatory to document a negative inquiry for clinical signs or symptoms of uremia... ." The rationale describes thepotential role for low protein diets and emphasizes the importance of adequate energy intake in this setting. Furthermore,the rationale goes on to state that the initiation of renal replacement therapy (RRT) should be considered if any of thefollowing nutritional indicators shows evidence of deterioration despite vigorous attempts to optimize protein and energyintake: (1) more than 10% reduction in usual body weight in nonobese individuals or to less than 90% of standard body http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (13 of 20) [05/25/2001 4:48:36 PM]
  20. 20. K/DOQI Update 2000weight (NHANES II) within 6 months, (2) greater than 10% decline in serum albumin (and below the lower end of thenormal range), or (3) a deterioration in SGA by one category.Dialysis Dose Targets and Transport StatusFor continuous ambulatory peritoneal dialysis (CAPD), the total delivered creatinine clearance dose target for low (L) andlow average (LA) transporters was lowered from 60 to 50 L/wk/1.73 m.2 The Kt/Vurea target for L and LA transportersremains at 2.0 per week. The creatinine and urea clearance targets for high (H) and high average (HA) transport types areunchanged.The rationale for lowering the creatinine target in L and LA transporters is that, even after controlling for delivered dose, Land LA transporters have better outcomes than do H and HA transporters.1 In the absence of adequate residual kidneyfunction (RKF), L and LA transporters may not be able to achieve a CCr of 60 L/wk/1.73 m2 on any reasonableprescription. However, because urea clearance is affected less than CCr by peritoneal transport status, L and LAtransporters can achieve a weekly Kt/V of 2.0. Therefore, it seems reasonable to lower the CCr target in L and LAtransporters without jeopardizing outcomes. These patients must be observed closely for evidence of inadequate PD. TheCanadian Society of Nephrology chose these targets because of new data that became available after the NKF-DOQIpublication of 1997.2 Thus, there was a broad consensus to make this change.ADDITIONS AND CLARIFICATIONSThe debate over whether peritoneal and residual kidney clearances are equivalent is not resolved. The clinical practiceguideline update elaborates on the debate. The rationale for the preservation of residual kidney function is emphasizedmore strongly.Throughout the guidelines update new data regarding the pediatric population have been added, which for the most part,corroborate the previous guidelines. In a few minor cases, some previous recommendations that were made for childrenwere withdrawn or qualified. The Nutrition guidelines include a major pediatric section that allowed for this to occursmoothly.The equations derived in the Modification of Diet in Renal Disease (MDRD) study to estimate GFR were added asmethods to estimate GFR in the setting of decreased kidney function. Specifically, the equations that use a combination ofdemographic, serum, and urine variables are now suggested for estimation of GFR.3Comments on the normalization of PD dosing measures using total body water and body surface area were expanded andupdated.Bergstrom et al derived new formulae to determine the normalized protein equivalent of nitrogen appearance, which wereadded to those included in the original guidelines.4 These formulae allow for inclusion or exclusion urinary and peritonealprotein losses.CORRECTIONSThe Dubois formula for body surface area was corrected to be in square meters rather than in square centimeters.Corrections also were made in the formulae for estimation of the total body water and body surface area of amputeepatients in Appendix E.ISSUES FOR FUTURE CONSIDERATION AND FOLLOW-UPAre the automated peritoneal dialysis (APD) therapies intermittent enough to require higher targets than continuoustherapies? This remains a dilemma and, in the absence of data to the contrary, the previous recommendations were notchanged. The argument is not over true intermittent therapies, such as nocturnal intermittent PD, but rather over whencontinuous cycling PD should be performed with one or two diurnal exchanges. These are asymmetric (over 24 hours) withregard to clearance, but is the asymmetry enough to require different dosing recommendations? This issue may have to be http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (14 of 20) [05/25/2001 4:48:36 PM]
  21. 21. K/DOQI Update 2000updated in the near future in light of the many studies underway to address it.REFERENCES 1. Churchill DN, Thorpe KE, Nolph KD, Keshaviah PR, Oreopoulos DG, Page D (CANUSA Study Group): Increased peritoneal membrane transport is associated with decreased patient and technique survival for continuous peritoneal dialysis patients. J Am Soc Neph 9:1285-1292, 1998 2. Clinical Practice Guidelines of the Canadian Society of Nephrology for Treatment of Patients with Chronic Renal Failure. Chapter 5: Guidelines for adequacy and nutrition in peritoneal dialysis. J Am Soc Nephrol 10:S289-S321, 1999 (suppl 13) 3. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D (MDRD Study Group): A more accurate method to estimate glomerular filtration rate from serum creatinine: A new prediction equation. Ann Int Med 130:461-470, 1999 4. Bergstrom J, Heimburger O, Lindholm B: Calculation of the protein equivalent of total nitrogen appearance from urea appearance. Which formulas should be used? Perit Dial Int 18:467-473, 1998.Vascular AccessSteve Schwab, MDFrom the Baylor College of Medicine, Houston, TX; the Renal Research Institute, New York, NY; Beth Israel Hospital Center, Boston, MA;Minor & James Medical Center, Seattle, WA; Vanderbilt University, Nashville, TN; Duke University Medical Center, Durham, NC; CovanceHealth Economics and Outcomes Services Inc; and The Johns Hopkins University, Baltimore, MD.THE VASCULAR Access Work Group reviewed all scientific literature published in English from the initial publicationof the NKF-DOQI guidelines in 1997 through 1999. Based on review of this literature, a limited number of significantchanges were made to the guidelines. In Guideline 3, it was the opinion of the Work Group that the weight of the evidencenow supports addition of a statement that a transposed brachiobasilic vein fistula is preferable to a PTFE graft providedsurgical expertise to establish a new AV fistula is available and venous anatomy is adequate. One published manuscriptshows the significantly better patency with a transposed brachiobasilic vein fistula compared to a PTFE graft,1 as do twomanuscripts that are currently in press.In addition, in Guideline 10, it was felt that there is now sufficient evidence to recommend intra-access flow monitoring asthe preferred technique for monitoring AV access. The primary reason for this recommendation is the superiority ofintra-access flow measurements in detecting venous outflow stenosis and in predicting stenosis in native AV fistula. Staticvenous pressures were considered to be the next most reliable technique, with dynamic venous dialysis pressures stillconsidered to be a satisfactory, but not preferred technique. A table for the interpretation of monthly intra-access flowmeasurements, as well as a method for monitoring static venous pressure changes,2-5 have been added to the Guideline.New evidence supports the use of antibiotic ointment at the catheter exit site in both cuffed and noncuffed catheters as amechanism for minimizing exit site infection and catheter-related bacteremia.6 Some manufacturers, however, haveindicated that ointments that contain glycol constituents should not be used on their polyurethane catheters. A specificrecommendation from C. R. Bard, Inc (Pittsburgh, PA), is identified in the guidelines.The Work Group identified an emerging body of evidence that suggests that lytic therapy applied to dialysis catheters,either by slow continuous infusion or by infusion throughout dialysis, has been shown to have significant benefit in thetreatment of fibrin sheaths. Preliminary trials using these techniques were indeed promising. However, the withdrawal ofUrokinase (Abbott, Abbott Park, IL) from the North American market limited additional studies that may have met theevidentiary basis to have this actually included as a guideline recommendation.7Novel subcutaneous dialysis access ports are also mentioned in the rationale of Guideline 5. Clinical trials regarding theirutility are currently underway and may result in the updating of their preferential use. http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (15 of 20) [05/25/2001 4:48:36 PM]
  22. 22. K/DOQI Update 2000REFERENCES 1. Matseura J, Rosenthal D, Clark M, et al: Transposed basillic vein versus PTFE for brachial axillary arteriovenous fistulae. Am J Surg 176:219-211, 1998 2. Bosman P, Boerboom FT, Smits H, et al: Pressure or flow recordings for surveillance of hemodialysis grafts. Kidney Int 52:1084-1088, 1998 3. May RE, Himmelfarb J, Ynicesu M, et al: Predicitive measures of vascular access thrombosis: A prospective study. Kidney Int 52:1656-1662, 1997 4. Neyra R, May R, Ikizler TA, et al: Time-dependent changes in intra-access blood flow is predicitive of subsequent vascular access thrombosis. Kidney Int 54:1714-1719, 1998 5. Besarab A, Frinak S, Sherman R, et al: Simplified measurement of intra-access pressure. J Am Soc Nephrol 9:284-289, 1998 6. Sesso R, Barbosa D, Leme I, et al: Staphylococcus aureus prophylaxis in hemodialysis patients using central venous catheters: Effect of mupirocin ointment. J Am Soc Nephrol 9:1085-1092, 1998 7. Twardowski Z: High dose intradialytic urokinase to restore the patency of permanent central vein hemodialysis catheters. Am J Kidney Dis 31:841-847, 1998Treatment of Anemia of Chronic Kidney DiseaseJoseph W. Eschbach, MDFrom the Baylor College of Medicine, Houston, TX; the Renal Research Institute, New York, NY; Beth Israel Hospital Center, Boston, MA;Minor & James Medical Center, Seattle, WA; Vanderbilt University, Nashville, TN; Duke University Medical Center, Durham, NC; CovanceHealth Economics and Outcomes Services Inc; and The Johns Hopkins University, Baltimore, MD.DURING THE 3 YEARS since the original 1997 guidelines regarding evidenced-based treatment of the anemia of chronickidney disease (CKD) were published, over 130 articles have been published on various aspects of anemia as it relates toeither erythropoietin (Epoetin) or CKD. The original Anemia Work Group was reconvened to evaluate these articles (onemember elected not to continue with the group) and concluded that 37 articles presented new data that supported theoriginal guidelines, or necessitated changes in a guideline, or should result in modification of the original rationale for aGuideline. Changes we have made in the guidelines are discussed below.Anemia causes many physiological abnormalities, which were well described in the original Introduction. New dataconfirm that intellectual performance decreases in pediatric patients with CKD who are anemic.1Perhaps the most significant new recommendation is that anemia should be quantified using hemoglobin rather thanhematocrit measurements. The rationale for this change is detailed in Guideline 1. Hematocrit, as measured by anautoanalyzer, is a product of the mean corpuscular volume (MCV) and the total erythrocyte count. Storage of ananticoagulated blood sample at room temperature for more than 8 hours (or for >24 hours when refrigerated), results inerythrocyte swelling and, therefore, in an erroneously high hematocrit. In contrast, the hemoglobin level remains constantunder the same conditions. Since many dialysis centers ship blood samples to distant laboratories, under poorly controlledenvironmental conditions, the risk of erythrocyte swelling is significant. Also, hyperglycemia increases the MCV, resultingin a falsely elevated hematocrit. Automated analyzers also vary a great deal in estimating the number and size oferythrocytes in a blood sample, such variability does not occur for measurement of hemoglobin. For these reasons,hemoglobin is the measurement of choice for all patients.The target hemoglobin/hematocrit (Guideline 4) of 11 to 12 g/dL/33% to 36% has been reaffirmed by new data showingthat patient survival is better when these values are >11 g/dL or >32% to 33%, respectively. An Italian study2 showed thatsurvival was better in those maintained at hematocrit values >32% compared with <32%. In the United States, a hematocritof 33% to 36% was associated with a 10% reduction in the risk of death when compared with patients maintained in a http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (16 of 20) [05/25/2001 4:48:36 PM]
  23. 23. K/DOQI Update 2000hematocrit range of 30% to 33%.3 In another study, 1,200 anemic hemodialysis patients with underlying heart disease wererandomized to be maintained at either a normal or low hematocrit group.4 The study was terminated early because therewas a detectable, albeit still nonstatistically significant, increased incidence of nonfatal myocardial infarctions or death inthose that were randomized to the normal hematocrit group. However, the 200 patients who attained and maintained anormal hematocrit (42% ± 3%) for at least 6 months had approximately a 15% mortality/year compared with a 40%mortality in patients maintained at a hematocrit of approximately 30%. This study also showed that in those cardiacpatients who were randomized to be maintained at a hematocrit of 30% ± 3%, survival improved in those who achievedhigher hematocrit levels.Additional studies that have been reported also confirm the value of maintaining hemoglobin values >11 and hematocrit>33%. Hospitalization rates were lower when the hematocrit was 33% to 36% compared with lower values5 and variousphysiological parameters: physical performance,6 cognitive function,7 and brain oxygen supply8 were better at a normalhemoglobin level than at lower levels. In striving to maintain the Hgb/Hct within this target range, the Hgb/Hct will likely,at times, rise above this range. The reasons why some patients will temporarily exceed an Hbg/Hct of 12g/dL/36% is thatthe response to Epoetin varies among patients, the interplay between IV iron supplementation and Epoetin dosing may beunpredictable, and it is mathematically impossible for the bell-shaped distribution for all patients to be limited to between11 and 12 g/dL of hemoglobin or 33% and 36% hematocrit. As of June 1999, HCFA will continue to providereimbursement for the cost of Epoetin alfa even if the Hct temporarily rises above their target range, as long as the rolling3-month average Hct is <37.5%. Medical justification is needed for maintaining the Hct above 36%.Guideline 7: Monitoring Iron Status, and Guideline 8: Administration of Supplemental Iron, have been modified to accountfor the availability of a new intravenous iron preparation, sodium ferric gluconate complex in sucrose (iron gluconate), andto eliminate the recommendation to wait 2 to 3 weeks after the last weekly dose of intravenous iron for an accuratemeasurement of serum ferritin and serum iron. If the weekly dose is 125 mg or less, these tests are accurate after 7 daysfollowing iron administration. However, for doses of 500 to 1,000 mg of IV iron, it is best to wait at least 2 weeks to obtainaccurate iron measurements. Iron gluconate, in contrast to iron dextran, comes in a preparation containing 62.5 mg/5 mL.Weekly dosing can be done with any fraction of this amount, just as occurs with iron dextran (12.5, 25, 50, or 100 mgdosing). In contrast to the situation for iron dextran, there are no data from experience in the United States that a singleinfusion of 500 to 1,000 mg of iron gluconate is safe. On the other hand, intravenous administration of iron gluconate hasnot been reported to cause fatal anaphylaxis, as can occur with iron dextran.Previously, there was concern that rapid intravenous administration of iron gluconate would result in "oversaturation" oftransferring, resulting in hypotension from circulating free iron. It is now known that this may be a laboratory artifactdepending on how serum iron is measured. When the laboratory method uses a buffer with ascorbic acid and guanidine,more iron is released from recently administered IV iron compounds, thus artificially raising the serum iron level andleading to the apparent "oversaturation" of transferrin, thus overestimating availability of "free iron." A better methodutilizes an acetate buffer with hydroxylamine hydrochloride, which measures iron bound to transferrin (true bioavailableserum iron).9Two new studies examine the relationship between serum ferritin levels (iron overload) and the incidence of infection indialysis patients. The author of a French study10 noted previously (prior to Epoetin) that an elevated serum ferritin levelwas one of three factors associated with an increased incidence of infection (the presence of a central dialysis catheter andhistory of previous infections being more important), but in a follow-up study11 in patients treated with Epoetin, the sameauthor noted that anemia (Hgb 9 g/dL), but not an elevated serum ferritin, was associated with an increased incidence ofbacteremia. Another study12 noted that in vitro neutrophil function was abnormal in a small group (n = 8) of hemodialysispatients who were receiving 30 mg of intravenous iron weekly and had a serum ferritin level >650 ng/mL (911 ± 69[SEM]). The patients also had transferrin saturation values <20% (16.5 ± 1.2), however. By definition, these patients werenot iron overloaded (because of their low transferrin saturation values), but the significance of this study awaits furtherresolution.Guideline 9: Administration of a Test Dose of IV Iron, has been rewritten to include iron gluconate. http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (17 of 20) [05/25/2001 4:48:36 PM]
  24. 24. K/DOQI Update 2000Guideline 11: Route of Administration of Epoetin, states that the preferred route of Epoetin administration is subcutaneous(SC) in hemodialysis patients. The largest study to date, based on male United States veterans, noted a 30% decrease in theaverage amount of Epoetin needed to maintain a hematocrit of 30% to 33% when Epoetin was administered SC comparedwith IV administration. However, 23% of the 208 patients required more Epoetin when switched from IV to SCadministration.13 On the other hand, a European study failed to show any greater efficiency of one route compared to theother.14 In aggregate, the bulk of the published data still suggest that SC administration results in a more efficient use ofEpoetin.Guideline 20: Causes for Inadequate Response to Epoetin. Two studies note that an elevated C-reactive protein level (oftenassociated with inflammation and/or infection) is a predictor of resistance to Epoetin.15,16 Previously, there was notenough data to list the use of angiotensin-converting enzyme (ACE) inhibitors as a potential cause of inadequate responseto Epoetin. Two new studies continue to provide conflicting data: one study noted that patients taking enalapril for bloodpressure control required approximately 75% more Epoetin to maintain the same hemoglobin than did patients treated withnifedipine or control patients not requiring antihypertensive drugs.17 On the other hand, another study failed to documentany resistance to Epoetin when ACE inhibitors were used in hemodialysis patients.18 Therefore, if patients on ACEinhibitors are noted to be requiring a greater than average amount of Epoetin, a change to another antihypertensive drug isnow worth considering.Guideline 24: Possible Adverse Effects Related to Epoetin Therapy: Hypertension. The etiology of this adverse effectcontinues to be investigated. Two in vitro studies demonstrate conflicting results: in one study, Epoetin inhibitedinterleukin-1þinduced apoptosis of vascular smooth muscle cells (which might induce hypertension since nitric oxideproduction is inhibited),19 whereas another study noted that longer-term exposure of human endothelial cells in culturewith Epoetin had a vasodilatory effect.20 These in vitro studies are contrasted to recent in vivo studies suggesting that asingle intravenous infusion (100 U/Kg) of Epoetin will increase mean arterial pressure (MAP), but that this effect does notoccur if the dose of Epoetin is given subcutaneously.21 The increase in MAP has been reported to be associated with anincrease in the ratio of plasma endothelin to proendothelin and/or an elevated cytosolic ionic calcium and nitric oxideresistance. Regardless of the mechanism, it does not seem to be related to the hemoglobin level, since two investigatorsnoted that the incidence of hypertension did not increase when the hemoglobin was increased to normal levels.4,22 Thecause of the Epoetin-associated clinical hypertension continues to remain unresolved.Guidelines 26 and 27 have been combined into a single guideline regarding Possible Adverse Effects Related to EpoetinTherapy: Increased Clotting Tendency. One new study notes that Epoetin therapy does not increase the risk of progressivestenosis in native fistulae,23 whereas another study noted that the incidence of access thrombosis increased in both nativefistulae and synthetic arteriovenous grafts in patients randomized to achieve a normal hematocrit.4 However, there was nocorrelation between the hematocrit level achieved, the dose of Epoetin and the occurrence of access thrombosis.Nevertheless, there still is the perception, by some, that Epoetin therapy increases the incidence of vascular clotting. In anattempt to allay concerns associated with this perception, we refer to the results of an autopsy study of Austrianhemodialysis patients treated with Epoetin that failed to note any increased incidence of preterminal pulmonarythromboembolism.24REFERENCES 1. Burke JR: Low-dose subcutaneous recombinant erythropoietin in children with chronic renal failure. Pediatr Nephrol 9:558-561, 1995 2. Locatelli F, Conte F, Marcelli D: The impact of haematocrit levels and erythropoietin treatment on overall and cardiovascular mortality and morbidityThe experience of the Lombardy Dialysis Registry [news]. Nephrol Dial Transplant 13:1642-1644, 1998 3. Ma JZ, Ebben J, Xia H, Collins AJ: Hematocrit level and associated mortality in hemodialysis patients. J Am Soc Nephrol 10:610-619, 1999 4. Besarab A, Bolton WK, Browne JK, et al: The effects of normal as compared with low hematocrit values in patients http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (18 of 20) [05/25/2001 4:48:36 PM]
  25. 25. K/DOQI Update 2000 with cardiac disease who are receiving hemodialysis and Epoetin. N Engl J Med 339:584-590, 1998 5. Xia H, Ebben J, Ma JZ, Collins AJ: Hematocrit levels and hospitalization risks in hemodialysis patients. J Am Soc Nephrol 10:1309-1316, 1999 6. McMahon LP, McKenna MJ, Sangkabutra T, Mason K, Sostaric S, Skinner SL, Burge C, Murphy B, Crankshaw D: Physical performance and associated electrolyte changes after haemoglobin normalization: A comparative study in haemodialysis patients. Nephrol Dial Transplant 14:1182-1187, 1999 7. Picket JL, Theberge DC, Brown WS, Schweitzer SU, Nissenson AR: Normalizing hematocrit in dialysis patients improves brain function. Am J Kidney Dis 33:1122-1130,1999 8. Metry G, Wikstrom B, Valind S, Sandhagen B, Linde T, Beshara S, Langstrom B, Danielson BG: Effect of normalization of hematocrit on brain circulation and metabolism in hemodialysis patients. J Am Soc Nephrol 10:854-863, 1999 9. Seligman PA, Schleicher RB: Comparison of methods used to measure serum iron in the presence of iron gluconate or iron dextran. Clin Chem 45:898-901, 199910. Hoen B, Kessler M, Hestin D, Fondu P: Risk factors for bacterial infections in chronic haemodialysis adult patients: A multicenter prospective survey. Nephrol Dial Transplant 10:377-381, 199511. Hoen B, Paul-Dauphin A, Hestin D, et al: EPIBACDIAL: A multicenter prospective study of risk factors for bacteremia in chronic hemodialysis patients. J Am Soc Nephrol 199912. Patruta SI, Edlinger R, Sunder-Plassmann G, et al: Neutrophil impairment associated with iron therapy in hemodialysis patients with functional iron deficiency. J Am Soc Nephrol 9:655-663, 199813. Kaufman JS, Reda DJ, Fye CL, et al: Subcutaneous versus intravenous administration of erythropoietin in hemodialysis patients. N Engl J Med 339:578-583, 199814. de Schoenmakere G, Lameire N, Dhondt A, et al: The haematopoietic effect of recombinant human erythropoietin in haemodialysis is independent of the mode of administration. Nephrol Dial Transplant 13:1770-1775, 199815. Barany P, Divino Filho JC, Bergstrom J: High C-reactive protein is a strong predictor of resistance to erythropoietin in hemodialysis patients. Am J Kidney Dis 29:565-568, 199716. Gunnell J, Yeun JY, Depner TA, et al: Acute-phase response predicts erythropoietin resistance in hemodialysis and peritoneal dialysis patients. Am J Kidney Dis 33:63-72, 199917. Albitar S, Genin R, Fen-Chong M, et al: High dose enalapril impairs the response to erythropoietin treatment in haemodialysis patients. Nephrol Dial Transplant 13:1206-1210, 199818. Abu-Alfa AK, Cruz D, Perazella MA, Mahnensmith RL, Simon D, Bia MJ: ACE inhibitors do not induce recombinant erythropoietin resistance in hemodialysis patients. Am J Kidney Dis 35:1076-1082, 200019. Angnostou A, Liu Z, Steiner M, Chin K, Lee ES, Kessimian N, Noguchi CT: Erythropoietin receptor mRNA expression in human endothelial cells. Proc Natl Acad Sci USA 91:3974-3978, 199920. Banerjee D, Rodriguez M, Nag M, Adamson JW: Exposure of endothelial cells to recombinant human erythropoietin induces nitric oxide synthase activity. Kidney Int 57:1895-1904, 200021. Kang D, Yoon K, Han D: Acute effects of recombinant human erythropoietin on plasma levels of proendothelin-1 and endothelin-1 in haemodialysis patients. Nephrol Dial Transplant 13:2877-2883, 199822. Berns JS, Rudnick MR, Cohen RM, et al: Effects of normal hematocrit on ambulatory blood pressure in epoetin-treated hemodialysis patients with cardiac Disease. Kidney Int 56:253-260, 199923. de Marchis, Cecchin E, Falleti E, et al: Long-term effects of erythropoietin therapy on fistula stenosis and plasma concentrations of PDGF and MCP-1 in hemodialysis patients. J Am Soc Nephrol 8:1147-1156, 199724. Wiesholzer M, Kitzwogerer M, Harm F, Barbieri G, Hauser A-C, Pribasnig A, Bankl H, Balcke P: Prevalence of preterminal pulmonary thromboembolism among patients on maintenance hemodialysis treatment before and after introduction of recombinant erythropoietin. Am J Kidney Dis 33:702-708, 1999http://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (19 of 20) [05/25/2001 4:48:36 PM]
  26. 26. K/DOQI Update 2000 © 2001 National Kidney Foundation, Inc web version created by cyberNephrologyTM and The Nephron Information Centerhttp://www.kidney.org/professionals/doqi/guidelines/doqi_upex.html (20 of 20) [05/25/2001 4:48:36 PM]
  27. 27. K/DOQI Update 2000 NKF K/DOQI GUIDELINES 2000Clinical Practice Guidelines for Nutrition in Chronic Renal FailureDOQI Home PageDisclaimerForewordK/DOQITM Advisory Board MembersK/DOQITM Nutrition Work Group Membership/Advisory Council/Steering CommitteeAcronyms and Abbreviations ListIntroductionMethodsCLINICAL PRACTICE GUIDELINESI. ADULT GUIDELINESA. Maintenance Dialysis 1. Evaluation of Protein-Energy Nutritional Status Guideline 1. Use of Panels of Nutritional Measures http://www.kidney.org/professionals/doqi/guidelines/doqi_nut.html (1 of 5) [05/25/2001 4:48:37 PM]
  28. 28. K/DOQI Update 2000 Guideline 2. Panels of Nutritional Measures for Maintenance Dialysis Patients Guideline 3. Serum Albumin Guideline 4. Serum Prealbumin Guideline 5. Serum Creatinine and the Creatinine Index Guideline 6. Serum Cholesterol Guideline 7. Dietary Interviews and Diaries Guideline 8. Protein Equivalent of Total Nitrogen Appearance (PNA) Guideline 9. Subjective Global Nutritional Assessment (SGA) Guideline 10. Anthropometry Guideline 11. Dual Energy X-Ray Absorptiometry (DXA) Guideline 12. Adjusted Edema-Free Body Weight (aBWef) 2. Management of Acid-Base Status Guideline 13. Measurement of Serum Bicarbonate Guideline 14. Treatment of Low Serum Bicarbonate 3. Management of Protein and Energy Intake Guideline 15. Dietary Protein Intake (DPI) in Maintenance Hemodialysis (MHD) Guideline 16. Dietary Protein Intake (DPI) for Chronic Peritoneal Dialysis (CPD) Guideline 17. Daily Energy Intake for Maintenance Dialysis Patients 4. Nutritional Counseling and Follow-Up Guideline 18. Intensive Nutritional Counseling With Maintenance Dialysis (MD)http://www.kidney.org/professionals/doqi/guidelines/doqi_nut.html (2 of 5) [05/25/2001 4:48:37 PM]
  29. 29. K/DOQI Update 2000 Guideline 19. Indications for Nutritional Support Guideline20. Protein Intake During Acute Illness Guideline 21. Energy Intake During Acute Illness 5. Carnitine Guideline 22. L-Carnitine for Maintenance Dialysis PatientsB. Advanced Chronic Renal Failure Without Dialysis Guideline 23. Panels of Nutritional Measures for Nondialyzed Patients Guideline 24. Dietary Protein Intake for Nondialyzed Patients Guideline 25. Dietary Energy Intake (DEI) for Nondialyzed Patients Guideline 26. Intensive Nutritional Counseling for Chronic Renal Failure (CRF) Guideline 27. Indications for Renal Replacement TherapyC. Appendices (Adult Guidelines) Appendix I. Methods for Measuring Serum Albumin Appendix II. Methods for Calculation and Use of the Creatinine Index Appendix III. Dietary Interviews and Diaries Appendix IV. Role of the Renal Dietitian Appendix V. Rationale and Methods for the Determination of the Protein Equivalent of Nitrogen Appearance (PNA) Appendix VI. Methods for Performing Subjective Global Assessment Appendix VII. Methods for Performing Anthropometry and Calculating Body Measurements and Reference Tables http://www.kidney.org/professionals/doqi/guidelines/doqi_nut.html (3 of 5) [05/25/2001 4:48:37 PM]
  30. 30. K/DOQI Update 2000 Appendix VIII. Serum Transferrin and Bioelectrical Impedance Analysis Appendix IX. Estimation of Glomerular Filtration Rate Appendix X. Potential Uses for L-Carnitine in Maintenance Dialysis PatientsD. References (Adult Guidelines)E. Index of Equations and Tables (Adult Guidelines)II. PEDIATRIC GUIDELINESA. Guidelines Guideline 1. Patient Evaluation of Protein-Energy Nutritional Status Guideline 2. Management of Acid-Base Status Guideline 3. Urea Kinetic Modeling Guideline 4. Interval Measurements Guideline 5. Energy Intake for Children Treated With Maintenance Dialysis Guideline 6. Protein Intake for Children Treated With Maintenance Dialysis Guideline 7. Vitamin and Mineral Requirements Guideline 8. Nutrition Management Guideline 9. Nutritional Supplementation for Children Treated With Maintenance Dialysis Guideline 10. Recommendations for the Use of Recombinant Human Growth Hormone (hGH) for Children Treated With Maintenance DialysisB. Appendix (Pediatric Guidelines) Appendix I. Procedures for Measuring Growth ParametersC. References (Pediatric Guidelines) http://www.kidney.org/professionals/doqi/guidelines/doqi_nut.html (4 of 5) [05/25/2001 4:48:37 PM]
  31. 31. K/DOQI Update 2000D. Index of Equations and Tables (Pediatric Guidelines)III. Biographical Sketches of the Work Group Members © 2000 National Kidney Foundation, Inc web version created by cyberNephrologyTM and The Nephron Information Center http://www.kidney.org/professionals/doqi/guidelines/doqi_nut.html (5 of 5) [05/25/2001 4:48:37 PM]
  32. 32. K/DOQI Update 2000 NKF K/DOQI GUIDELINES 2000K/DOQITM DisclaimerThese guidelines are based on the best information available at the time of publication. They are designed to provideinformation and assist in decision making. They are not intended to define a standard of care, and should not be construedas one. Neither should they be interpreted as prescribing an exclusive course of management. Variations in practice willinevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources,and limitations unique to an institution or type of practice. Every healthcare professional making use of these guidelines isresponsible for evaluating the appropriateness of applying them in the setting of any particular clinical situation.K/DOQI is a trademark of the National Kidney Foundation.FOREWORDFrom its rudimentary beginnings in the 1960s, renal replacement therapy has become a lifesaving treatment that canprovide end-stage renal disease (ESRD) patients with a good quality of life. As a result, the number of ESRD patients whoreceive renal replacement therapy has risen, and their survival has increased, but considerable geographic variability existsin practice patterns and patient outcomes. It was this realization, and the belief that substantial improvements in thequality and outcomes of renal replacement therapy were achievable with current technology, that prompted severalorganizations to seek to reduce variations in ESRD treatment with the goal of a more uniform delivery of the highestpossible quality of care to dialysis patients. Notable among these efforts were the report on "Measuring, Managing andImproving Quality in the ESRD Treatment Setting" issued by the Institute of Medicine in September 1993; the "Morbidityand Mortality of Dialysis" report issued by the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) inNovember 1993; the Core Indicator Project initiated by the ESRD Networks and the Health Care FinancingAdministration (HCFA) in 1993; the "Clinical Practice Guidelines on the Adequacy of Hemodialysis" issued by the RenalPhysicians Association in December 1993; and the Dialysis Outcomes Quality Initiative (DOQI) initiated by the NationalKidney Foundation (NKF) in 1995.In keeping with its longstanding commitment to the quality of care delivered to all patients with kidney and urologicdiseases, the NKF convened a Consensus Conference on Controversies in the Quality of Dialysis Care in March 1994.Following a series of nationwide town hall meetings held to obtain input into the recommendations made at the ConsensusConference, the NKF issued an "Evolving Plan for the Continued Improvement of the Quality of Dialysis Care" inNovember 1994. A central tenet of the plan was recognition of an essential need for rigorously developed clinical practiceguidelines for the care of ESRD patients that would be viewed as an accurate and authoritative reflection of currentscientific evidence. It was to this end that the NKF launched the "Dialysis Outcomes Quality Initiative" (DOQI) in March1995, supported by an unrestricted grant from Amgen, Inc.The objectives of DOQI were ambitious: to improve patient survival, reduce patient morbidity, improve the quality of lifeof dialysis patients, and increase efficiency of care. To achieve these objectives, it was decided to adhere to severalguiding principles that were considered to be critical to that initiatives success. The first of these principles was that theprocess used to develop the DOQI guidelines should be scientifically rigorous and based on a critical appraisal of all http://www.kidney.org/professionals/doqi/guidelines/nut_intro.html (1 of 10) [05/25/2001 4:48:39 PM]

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