"CRRT Complications and Troubleshooting"


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  • The USP MER Program results of KCL error reports led to the following FDA labeling changes #1 - to give more prominence to the need to dilute the product prior to use;
  • Endotoxins are potent activators of the complement system and other immunoregulators (IL6, TNF  , cytokines) host responses to endotoxin are dose dependent and include pyrogenic reactions, shock, decrease in SBP, and death bicarbonate concentrate unlike acetate concentrate can support rapid bacterial growth and endotoxin production HD with non sterile dialysate has been shown to be associated with greater interleukin 1 production than with sterile dialysate in a grp of HD patients shifted for one month from non sterile bicarbonate dialysate to ultrapure bicarbonate dialysate, plasma levels of IL 1 and TNF were found to decrease significantly levels of  2 microglobulin and and the incidence of carpel tunnel syndrome were lower in patients on ultrapure dialysate use of sterile endotoxin free dialysate is advocated bacterial products such as endotoxins are potent stimuli of inflammatory reactions through complement activation, increased monokine production & up regulation at the surface of leukocytes of molecules involved in cell adhesion and activation Tielemans showed that bacterial contamination of bicarbonate dialysate, at levels associated with clinical hemodialysis, neither enhanced the level of complement activation nor the secretion of monokines IL6 and TNF  (Tielemans C et al. Effects of ultrapure and non-sterile dialysate on the inflammatory response during in vitro hemodialysis. KI 1996; 49: 236-243.)
  • Replacement fluid must be sterile Whether dialysate must be sterile or ultra pure depend on whether there is back filtration or back diffusion Back filtration depends on pressure profiles and membrane permeability Synthetic high flux membranes allow less back diffusion than cellulose high or low flux membranes
  • "CRRT Complications and Troubleshooting"

    1. 1. CRRT Complications and Troubleshooting Sheldon Tobe, Sunnybrook Health Sciences Centre
    2. 2. Objectives <ul><li>At the end of this presentation, the health care provider will be able to: </li></ul><ul><li>List the potential errors associated with pharmacy prepared solutions </li></ul><ul><li>Review actual errors associated with CRRT solutions that have occurred in different institutions </li></ul><ul><li>Apply the information to a case study </li></ul>
    4. 4. Potential for Errors in CRRT <ul><li>Physician errors when using non standard orders for dialysate or replacement solutions </li></ul><ul><li>Nursing administration errors in choice of solutions </li></ul><ul><li>Pharmacy transcription errors in dialysate orders </li></ul><ul><li>Pharmacy calculation errors in compounding </li></ul><ul><li>Pharmacy product selection errors in compounding </li></ul>
    6. 6. Administration Errors <ul><li>Confusion of calcium chloride infusion bags for sodium bicarbonate replacement solution bags </li></ul><ul><li>Labeling of calcium chloride infusion bags with bright fluorescent stickers by pharmacy </li></ul><ul><li>Separation of replacement fluids from calcium chloride bags in separate bins </li></ul>
    7. 7. Administration Errors <ul><li>Nursing mixed concentrated Normocarb dialysate with normal saline instead of sterile water </li></ul><ul><li>Pharmacy mixing of Normocarb? </li></ul>
    8. 9. Dialysate Compounding Errors <ul><li>Foothills Medical Centre, Calgary Health Region </li></ul><ul><ul><li>83 yo female in CV ICU died suddenly in the presence of family and physicians </li></ul></ul><ul><ul><li>ICU physician suspected dialysate used for CRRT </li></ul></ul><ul><ul><li>An analysis of dialysate solutions revealed potassium chloride was used in place of sodium chloride </li></ul></ul><ul><ul><li>Attributed to another death that occurred one week prior </li></ul></ul>
    9. 10. Foothills Medical Centre, CHR <ul><li>3 liter bags prepared in batches of 36 bags </li></ul><ul><li>Dialysate concn Na 110 mEq/L, Mg 0.7 mEq/L </li></ul><ul><li>Prepared by 4 pharmacy technicians involved in setup and documentation, checking of setup, product transfer, final check </li></ul><ul><li>No empty bottle verification against worksheet </li></ul><ul><li>No pharmacist check of final product </li></ul>
    10. 11. Foothills Medical Centre, CHR <ul><li>At FMC, 34% of the pharmacy staff were pharmacists </li></ul><ul><li>National averages are 44% pharmacists </li></ul><ul><li>“ Tech check tech” delegation endorsed by CSHP </li></ul><ul><li>Over delegation of pharmacist responsibilities? </li></ul>
    11. 12. CHR Recommendations <ul><li>“ The feasibility of using commercially prepared dialysate solutions be explored.” </li></ul><ul><li>“ When patient care issues necessitate that in-house manufacturing of complex preparations be undertaken, process mapping be used to simplify the processes as much as possible.” </li></ul>
    12. 13. FDA Labeling Changes <ul><li>Death due to the accidental misadministration of concentrated KCl Injection led to: </li></ul><ul><ul><li>Changing the official USP name to Potassium Chloride for Injection Concentrate (emphasis added) </li></ul></ul><ul><ul><li>Labels must now bear a boxed warning &quot;Concentrate: Must be Diluted Before Use;&quot; </li></ul></ul><ul><ul><li>The cap must be black in color (the use of black caps is restricted to this drug product only) </li></ul></ul><ul><ul><li>The cap must be imprinted in a contrasting color with the words, &quot;Must be Diluted.&quot; </li></ul></ul>
    13. 14. Different Perspectives <ul><li>According to ISMP survey, 91% nurses vs 98% pharmacists consider IV KCL to be a high alert medication </li></ul><ul><li>73% nurses vs 94% pharmacists consider hypertonic sodium chloride inj to be a high alert medication </li></ul>
    14. 15. Time Requirements <ul><li>Pharmacy needs advanced notice to prepare dialysate, replacement fluids, calcium chloride, citrate infusions </li></ul><ul><li>Often the same patient requires pressors that need to be mixed by pharmacy </li></ul><ul><li>Daily rounding and ordering of solutions by ICU pharmacist to determine need </li></ul>
    15. 16. USP 797 <ul><li>Immediate Use Exemption from ISO Class 5 (Class 100) </li></ul><ul><li>Three or fewer sterile products may be prepared in worse than ISO Class 5 air when there is no direct contact contamination, and administration begins within 1 hour and is completed within 12 hours of preparation. </li></ul>
    16. 17. USP 797 <ul><li>Need for aseptic preparation? </li></ul><ul><ul><li>IHD data on bicarbonate dialysate </li></ul></ul><ul><ul><ul><li>Bacterial growth and endotoxin production </li></ul></ul></ul><ul><ul><ul><li>Sterile versus non sterile dialysate </li></ul></ul></ul><ul><ul><ul><li>IL 1 production </li></ul></ul></ul><ul><ul><li>Interleukin hypothesis </li></ul></ul>
    17. 18. Water and Dialysate Quality - 0.03 10 -6 Sterile - 0.03 0.1 Ultra-pure + 0.25 100 Tap water + 5 200 AAMI water + 5 2000 AAMI dialysate Cytokine induction Endotoxin EU/mL Bacterial Growth cfu/mL Classification
    18. 19. Case Study <ul><li>What happened? </li></ul><ul><li>Analysis of the replacement fluid revealed that the NaHCO3 was never placed in the solution and the total Na was 105 mEq/L </li></ul>
    19. 20. Case Study <ul><li>Root Cause Analysis </li></ul><ul><ul><li>Why was sodium bicarbonate not added to the solution? </li></ul></ul><ul><ul><li>Are the replacement solutions prepared in batches or on a patient by patient basis? </li></ul></ul><ul><ul><li>What is the process for pharmacy set-up, preparation, final check and documentation? </li></ul></ul><ul><ul><li>Are the products and syringes made available for final check? </li></ul></ul><ul><ul><li>Is the pharmacist involved in checking the final product? </li></ul></ul>
    20. 21. Extemporaneous Compounded Solutions *mEq/L unless otherwise stated 0 1.8 mg/ dL 2.35 mg/ dL 0 25 110 Per order 135 U of Michigan N/A 1.4 mg/ dL 0 3 37 107 3-4 144 Cleveland Clinic, LeBlanc/ Paganini 0.1% 1.5 mEq/L 0 0 0-40 121.5 0-5 117 UCSD, Mehta Dextrose Mg PO4 Ca HCO3 Cl K Na Solution
    21. 22. Comparison of Commercial Dialysate 55 mmol/L 0.75 0 1.5 30 0 117 2 140 Baxter HF 0 0.75 0 0 0 35 106.5 0 140 Normocarb 83 mmol/L 0.5-1.5 0 1.5 40 0 96-102 0 132 1.5% PD 0 0 0 1.5 28 0 109 4 130 RL Dextrose Mg PO4 Ca Lactate HCO3 Cl K Na Solution
    22. 23. 0 1 0 3 32 108 2 140 Prismasate BK2/0 110 1.5 0 3 32 120.5 4 140 Prismasate B25GK4/0 110 1.5 2.5 3 32 113 4 140 Prismasate BGK4/2.5 Glucose mg/dL Mg Ca Lactate HCO3 Cl K Na Solution 110 1.5 2.5 35 0 109 0 140 Prismasate LGK0/2.5 110 1 0 3 32 108 2 140 Prismasate BGK2/0 0 1 3.5 3 32 109.5 0 140 Prismasate BK0/3.5
    23. 24. Recommendations <ul><li>Use commercially available products whenever feasible </li></ul><ul><li>Standard physicians orders for CRRT solutions </li></ul><ul><li>Separate look alike drugs in the pharmacy </li></ul><ul><li>Ensure process for pharmacy prepared solutions is mapped out </li></ul><ul><li>Ensure pharmacist is the final check! </li></ul><ul><li>Training, training, training! </li></ul><ul><li>Label and separate solutions at the bedside in appropriate bins </li></ul>
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