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    • Prospective, Observational, Multicenter Study ofGastrointestinal Dysfunction in Critically Ill Patients. Development of Gastrointestinal Failure Score. Study protocol Date: 16/04/2009 10:00AM Template as developed by the Clinical Trials Workgroup Of the World Society of the Abdominal Compartment Syndrome 1
    • PART A. Summary of the studyPrincipal investigators:Joel Starkopf MD, PhDUniversity of Tartu, Tartu, EstoniaTartu University Clinics, Tartu, EstoniaManu Malbrain, MD, PhDZNA StuivenbergAntwerpen, BelgiumMartin Björck, MD, PhDUppsala University HospitalUppsala, SwedenAnnika Reintam MD, PhDUniversity of Tartu, Tartu, EstoniaStudy centers and number of patients planned: 25 centers, 500 patients.Study participants (Name plus affiliation, listed alphabetically):…..Study period Enrollment of first patient: dd/mmm/yyyy Estimated date of last patient in study: dd/mmm/yyyy 2
    • ObjectivesPrimary objective• To create the best GIF score in prediction of ICU and 28-day mortality of adult, mechanically ventilated intensive care patients.Secondary objective(s)• To describe the incidence and impact on 28-days mortality of GI symptoms, food intolerance/underfeeding and IAH among mechanically ventilated, adult intensive care patients.• To evaluate the additive effect of GIF score on SOFA score in prediction of 28-days mortality in adult, mechanically ventilated intensive care patients.Study designProspective, observational, multicenter studyPatient populationConsecutive adult mechanically ventilated patients, admitted to the participating ICU-sduring one week of study period.Duration of the study periodFor the individual patient1. Study period 7 days2. Follow-up period of 28 daysEndpointsPrimary endpointPrognostication of 28 days mortality in adult mechanically ventilated intensive carepatients.Secondary endpointsEvaluation of the prognostic value of GIF sub-score in combination with SOFA score.Identification of the incidence of GI symptoms, food intolerance/underfeeding and IAHamong mechanically ventilated, adult intensive care patients. 3
    • PART B. Study protocol1. INTRODUCTION1.1 BackgroundVarious symptoms of gastrointestinal (GI) dysfunction – diarrhoea, decreased bowelsounds, abdominal distension, etc. – are frequent in critically ill patients [1]. Foodintolerance is evident in 46% to 57% of ICU patients [2,3,4]. Intra-abdominalhypertension (IAH), defined as sustained intra-abdominal pressure (IAP) above 12mmHg, occurs in 50% and abdominal compartment syndrome (IAP > 20 mmHg withonset of new organ failure) in 8% of ICU patients of mixed population [5]. Significantimpact of both food intolerance and IAH on ICU outcome has been demonstrated[2,3,5,6,7].The hypothesis that the GI tract could be a source of secondary organ dysfunction hasexisted for several decades [8,9]. Even though the GI tract was called “the motor oforgan failure” [10], gastrointestinal failure (GIF) itself is not routinely assessed as a partof multiorgan failure (MOF). For complex evaluation of all vital organs, several scoringsystems for MOF have developed. The GI system, however, is not included in any of thescores (APACHE; SOFA, etc) widely used today. To characterize GI function incritically ill patients, we have proposed a new GIF score, which combines foodintolerance and IAH into one grading system (Table 1) [11]. Preliminary, single-centreprospective study demonstrated high prognostic value of this score [12]. This particularscore, however, has important limitation such as the estimation of food intolerance,which may be observer dependent. Another potential problem is that the variables in thescore may not represent truly continuous variables [13]. Therefore, in the present studythe aim is to create the best possible gastrointestinal failure score in critically ill patients.After validation, the major applications of the future score would be the monitoring ofdynamics of organ failure and to assess the effects of therapeutic interventions on itscourse. Future usage of the GIF-score together with SOFA-score would allow betterunderstanding of interrelation between the failures of the various organs.1.2. Rationale for the studyPresent study evaluates the different variations of possible gastrointestinal failure (GIF)score by their prognostic value in prediction of ICU and 28-day mortality in adult,mechanically ventilated critically ill patients. Consecutive patients, admitted to the ICUduring one week will be studied. At the baseline, admission parameters will be collec-ted. During the following 7 days, the SOFA score, precisely defined GI symptoms, foodintolerance/underfeeding and IAP/APP will be documented. The patients will thereafterbe followed for outcome for 28 days, and prognostic value for GI symptoms, food intol-erance/underfeeding and IAP/APP on the 28-day survival will be evaluated. Variables(GI symptoms, food intolerance/underfeeding and IAH/APP) with greatest impact, i.e.independent risk factors of mortality will be identified and combined into new 5 gradeGIF score, build up of which follows the logic of organ failure sub-scores in SOFAscore. The following analysis will investigate the predictive power of a possible GIFscore variants on mortality, and thereby makes it possible to identify the best GIF score. 4
    • If the GIF score will appear highly predictive for ICU mortality, it can be suggested as astandardized measurement tool in interventional studies, investigating strategies aimedto improve GI function in critically ill patients.2. STUDY OBJECTIVESPrimary objective• To evaluate the prognostic value of developed GIF score in prediction of 28-day mortality of adult, mechanically ventilated intensive care patients.Secondary objective• To describe the incidence and impact on 28-day mortality of GI symptoms, food intolerance/underfeeding and IAH among mechanically ventilated, adult intensive care patients.• To evaluate the additive effect of GIF score on SOFA score in prediction of 28-day mortality in adult, mechanically ventilated intensive care patients.3. STUDY PLAN AND PROCEDURES3.1. Overall designThis is a prospective, observational, multicenter study, designed to validate the GIFscore in adult, and mechanically ventilated, ICU patients. Consecutive adultmechanically ventilated patients, admitted to the participating ICU-s during one week ofstudy period will be enrolled. Approval of local ethic committee will be obtained priorstudy initialization. The study will consist of three phases:1. Screening assessment, documentation of admission parameters2. Study period of 7 days3. Follow-up period of 28 days 5
    • The study design will be as follows Screening assessment, admission parameters - Day 1.1. Informed consent will be obtained from the subject or nominated representative if requested by local Ethics Committee.2. The inclusion and exclusion checklists will be completed and suitability of the subject for entry into the study will thus be confirmed.3. The following data will be recorded at baseline, i.e. on admission to ICU (Appendix 1): • Gender, age, weight, height, intensive care profile, reason for ICU admission, principal pathology, site of surgery, site and severity of infection, lactate, APACHE II score. • The clinical conditions associated with IAH according to WSACS consensus [15] (Table 5). Study period – day 1 to 7 in ICU.Data collectionThe following data of 1st, 2nd, 4th and 6th day will be collected:1. Feeding • The amount of enterally given calories • The route of enteral feeding (pre- or postpyloric) • The type of enteral nutrition in regards to kcal/ml • The specific type of enteral nutrition (fibre etc.) • The amount of parenterally given calories2. The GI symptoms and the reason(s) for the reduction of enteral feeding: • abdominal surgery within 3 previous days • elective • emergency • decompressive laparatomy due to ACS • absent or pathological bowel sounds • vomiting • high gastric residual volume 6
    • • diarrhoea • IAH • bowel distension • short bowel syndrome • GI bleeding • constipation • other (describe) • other than GI reasons for withholding/reduction of enteral feeding (i.e. shock, procedures etc.)3. Medications used to influence the gastrointestinal function and procedures to lower the IAP • prokinetic: metoclopramide, cisapride, prostygmin or neostygmin, other (specify) • laxative: lactulose, bisacodyl, other (specify) • sedation/analgesia/neuromuscular blockade • nasogastric/rectal decompression • drainage for removal of abdominal/retroperitoneal fluids • aimed negative fluid balance (diuretics/hemofiltration) • other (specify)4. Intra-abdominal pressure (IAP):IAP will be measured either continuously or intermittently and registered at least once inevery 6 hrs. When intermittent measurements are performed they can either be with themodified Kron’s method (instillation of 25 ml) or with the Foley Manometer method.Pressure measurements technique should be in accordance with the Guidelines of WorldSociety on Abdominal Compartment Syndrome [15].Mean arterial pressure will be documented at the same time with IAP measurement forcalculation of abdominal perfusion pressure (APP).Abdominal perfusion pressure will be calculated as APP = MAP – IAP.Intra-abdominal hypertension (IAH) is defined as sustained IAP ≥ 12mmHg.Abdominal compartment syndrome (ACS) is defined as sustained IAP > 20mmHgwith new organ failure.Based on collected data different variations of GIF score will be calculated by investig-ators for each patient in post-hoc analyses. GIF score combines the GI symptoms, foodintolerance/underfeeding and/or IAP into five-graded scale. The possible examples areprovided in Table 1 and Table 2. The best score will be determined with the ultimateaim to find a score, which allows the best prediction of ICU outcome. 7
    • 5. Sequential Organ Failure Assessment (SOFA) scoreThe score is based on serial assessment of respiratory, coagulation, cardiovascular,central nervous, liver and renal function, Appendix 2 [16]. The worst recordings fromlast 24 hours will accounted for calculations. The sub-scores for each organ system willbe documented. For scoring, the following blood analyses, at least once daily, arenecessary: • arterial blood gases; • platelet count; • serum bilirubin; • serum creatinin;For scoring, the following assessments, at least once daily, are necessary: • use of vasopressors, inotropes • FiO2 • Urine output • Glasgow Coma Scale (assumable in deeply sedated patients)6. Additional assessments and analyses • Fluid balance per 24 h (calculated with absolute losses) • Serum albumin (lowest) • C-reactive protein (lowest) 8
    • Follow-up period – day 7 to 28Follow-up period lasts until 28 days after enrolment. At the end of this period, thefollowing data are recorded by ticking in CRF1. Survival2. The decision of withdrawal/withholding the treatment will be documented, if taken3. ICU length of stay If patient is still in the ICU at day 28, ongoing intensive care will be ticked in CRF.4. Duration of mechanical ventilation If the patient is still on mechanical ventilation at day 28, ongoing ventilation will be ticked in CRF. 9
    • 3.2. Selection of the study populationAll patients, consequently admitted to the participating ICU during the study week, willbe screened for study inclusion.3.2.2. Inclusion criteriaFor inclusion in the study, subjects must fulfil all of the following criteria:1. Admission to ICU during the study week (the patients already in the ICU at the time the study starts will not be included)2. Age at least 18 years3. Mechanical ventilation started at the day of admission or earlier and expected to be continued for at least 6 hours4. Possibility to implement intra-abdominal pressure monitoring via bladder5. Signed informed consent (if requested by local Ethics Committee)3.2.3. Exclusion criteria.Any of the following is regarded as a criterion for exclusion from the study:1. Age <18 years2. Spontaneous ventilation, or mechanical ventilation for less than 6 hours3. Intra-abdominal pressure monitoring not applicable for any reason3.2.4. Sample size calculationSince this study is epidemiological no sample size calculation may be performed3.3. Rationale for the study designProspective, multicenter study would be the only opportunity to create the best scorewidely applicable for ICU patients. 10
    • 4. STUDY MEASUREMENTS AND ENDPOINTS 4.1. Primary endpoint Prognostication of 28-day survival. 4.2. Screening and demographic measurementsThe following data will be recorded at baseline, i.e. on admission to ICU. • Gender • Age • Body weight and height • Serum lactate • Profile (Appendix 1) • Reason for ICU admission (Appendix 1) • Principal pathology (Appendix 1) • Site of surgery (Appendix 1) • Site and severity of infection (Appendix 1) • Acute Physiology and Chronic Health Evaluation (APACHE) II score (Appendix 2)[14]. Worst score in first 24 hrs after ICU admission will be documented. • The clinical conditions associated with IAH according to WSACS consensus [15] (Appendix 2). 4.3. Measurements during the study, performed on days 2, 3, 5 and 7 4.3.1. Intra-abdominal pressure (IAP), data for the last 24 hours • Mean of the measurements • Maximum • Minimum 4.3.2. Abdominal perfusion pressure (APP), data for the last 24 hours • Mean of the measurements • Maximum • Minimum 4.3.3Presence or absence of abdominal compartment syndrome (yes/no, primary/secondary) during the last 24 hours 4.3.4Feeding during last 24 hours • The calculated requirements according to Harris-Benedict equation 11
    • • The amount of enterally given calories/24 hrs (carbohydrates, proteins and lipids) • The route of enteral feeding (pre- or postpyloric) • The type of enteral nutrition in regards to kcal/ml • The specific type of enteral nutrition (fibre etc.) • The amount of parenterally given calories/24 hrs (carbohydrates, proteins and lipids)4.3.5 GI symptoms and the reason(s) for the reduction of enteral feeding for the last 24hours:For each variable the presence of it is marked, and whether the presence of this variableis the reason for the reduction of enteral feeding. Several reasons may be marked forthe same day. • abdominal surgery within 3 previous days • elective • emergency • decompressive laparatomy due to ACS • absent or pathological bowel sounds • vomiting (document the approximate volume as regurgitation/moderate/profuse and the times per day) • high GRV (document the maximum amount per one measurement and the total per 24 hrs) • diarrhoea (document the times per day or the amount of stool) • IAH • bowel distension (suspected or radiologically confirmed - document the location and diameter) • short bowel syndrome (previous or after recent surgery) • GI bleeding (mild – no specific treatment, moderate – up to 2 packs of red cells, severe – more than 2 packs of red cells) • upper • lower • constipation (days without stool) • other GI symptom (describe) • other than GI reasons for withholding/reduction of enteral feeding • shock • scheduled procedures or operations • other (describe) 12
    • 4.3.6 Medications and procedures used during the previous 24 hoursto influence the gastrointestinal function: • prokinetic: metoclopramide, cisapride, prostygmin or neostygmin, other (specify) • laxative: lactulose, bisacodyl, other (specify) • other (specify)to lower the IAP: • sedation/analgesia/neuromuscular blockade • nasogastric/rectal decompression • drainage for removal of abdominal/retroperitoneal fluids • aimed negative fluid balance (diuretics/hemofiltration) • other (specify)4.3.7 SOFA (Table 4)In electronic CRF the values for each variable for respective sub-score are documented,the sub/scores and the total score will be calculated automaticallyFor scoring, the following blood analyses (at least once in days 1 ,2 ,4 and 6) arenecessary: • arterial blood gases • platelet count • serum bilirubin • serum creatininFor scoring, the following assessments (in days 1 ,2 ,4 and 6) are necessary: • use of vasopressors, inotropes • FiO2 • urine output in 24 hours • Glasgow Coma Scale (assumable in deeply sedated patients)4.3.8 Additional assessments and analyses • mechanical ventilation (any respiratory support ≥ 6 h in last 24 hours) • fluid balance of last 24 h (calculated with absolute losses) • serum albumin, if measured (lowest in last 24 hours) • C-reactive protein, if measured (highest in last 24 hours) 13
    • 4.4. Primary endpoint and method of assessment.Univariate analyses of admission parameters will be applied to identify the risk factorsfor 28-days mortality. Parameters with p<0.2 are thereafter entered into the multiplelogistic regression model to identify the independent risk factors. The impact of differentvariations of GIF score on prediction of mortality will be evaluated.4.5. Secondary endpoints and methods of assessment.Multiple logistic regression analysis will be performed to evaluate the prognostic valueof first three days SOFA score alone or in combination with the best GIF sub-score on28-day mortality.5. DATA MANAGEMENT AND STATISTICSElectronic case report forms will be provided for the recording of the data.Statistical analysisData analysisGeneral linear model and the Receiver Operating Characteristics (ROC) curves will beused for evaluation of prognostic value of GIF score. 14
    • 6. REFERENCES.1. Dark DS, Pingleton SK. Nonhemorrhagic gastrointestinal complications in acute respiratory failure. Crit Care Med. 1989; 17(8): 755-82. Mentec H, Dupont H, Bocchetti M, Cani P, Ponche F, Bleichner G. Upper digestive intolerance during enteral nutrition in critically ill patients: frequency, risk factors, and complications. Crit Care Med. 2001; 29(10): 1955-613. Montejo JC, Grau T, Acosta J et al. Multicenter, prospective, randomized, single- blind study comparing the efficacy and gastrointestinal complications of early jejunal feeding with early gastric feeding in critically ill patients. Crit Care Med. 2002; 30(4): 796-8004. Chang RW, Jacobs S, Lee B. Gastrointestinal dysfunction among intensive care unit patients. Crit Care Med. 1987; 15(10): 909-145. Malbrain ML, Chiumello D, Pelosi Pet al. Prevalence of intra-abdominal hypertension in critically ill patients: a multicentre epidemiological study. Intensive Care Med. 2004; 30(5): 822-96. Malbrain ML, Chiumello D, Pelosi P et al. Incidence and prognosis of intraabdominal hypertension in a mixed population of critically ill patients: a multiple-center epidemiological study. Crit Care Med. 2005; 33(2): 315-227. Reintam A, Parm P, Kern H, Starkopf J. Impact of intraabdominal pressure on ICU mortality. Intensive Care Med. 2005; 31, Suppl 1: S88. Carrico CJ, Meakins JL, Marshall JC, Fry D, Maier RV. Multiple organ failure syndrome. Arch Surg. 1986; 121: 196-2089. Mainous MR, Tso P, Berg RD, Deitch EA. Studies of the route, magnitude, and time course of bacterial translocation in a model of systemic inflammation. Arch Surg. 1991; 126: 33-3710. Wiest R, Rath HC. Bacterial translocation in the gut. Best Practice & Research Clinical Gastroenterology. 2003; 17(3): 397-42511. Reintam A, Kern H, Starkopf J. Defining gastrointestinal failure. Acta Clin Belg. Suppl. 2007;(1):168-72.12. Reintam A, Parm P, Kitus R, Starkopf J, Kern H. Gastrointestinal Failure Score in critically ill patients: a prospective observational study. Crit Care,12(4):R90, 2008 [Epub ahead of print]13. Khadaroo RG, Marshall JC.Gastrointestinal dysfunction in the critically ill: can we measure it? Crit Care. 2008, 24;12(5):180. [Epub ahead of print]14. Knaus WA, Draper EA, Wagner DP, Zimmerman JE (1985) APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-2915. Malbrain ML, Cheatham ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppaniemi A, Olvera C, Ivatury R, DAmours S, Wendon J, Hillman K, Johansson K, Kolkman K, Wilmer A. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. I. Definitions. Intensive Care Med 2006; 32:1722-32.16. Vincent JL et al. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction / failure. Intensive Care Med. 1996; 22:707-710 15
    • APPENDIX 1DEFINITIONSProfile will be recorded as follows: 1. medical – no surgery in 4 weeks preceding ICU admission 2. elective surgical – surgery in 4 weeks preceding admission, scheduled > 24 hrs in advance 3. emergency surgical - surgery in 4 weeks preceding admission, scheduled within 24 hrs of operationIntra-abdominal hypertension (IAH) is defined as sustained IAP ≥ 12mmHgAbdominal Compartment Syndrome (ACS) is defined as sustained IAP > 20mmHg withnew organ failureSeverity of infection will be evaluated according to the Surviving SepsisGuidelines/Definitions as follows: 1. no sepsis – no suspected or confirmed infection 2. sepsis – suspected or confirmed infection with the symptoms of systemic inflammatory reaction 3. severe sepsis – sepsis with at least 1 organ failure 4. septic shock – severe sepsis with hypotension sustained despite adequate fluid resuscitationCODESReason for ICU admission 1. Neurological 2. Respiratory 3. Cardiac 4. Thoracic surgery 5. Vascular Surgery 6. Hepatic 7. Renal 8. Metabolic disorders 9. Multiple organ failure 10. Shock 11. Postoperative mechanical ventilation 12. Other 16
    • In case of shock please state 1. Septic shock 2. Cardiogenic shock 3. Hemorrhagic shock 4. Hypovolemic shock 5. Anaphylactic shock 6. Mixed 7. OtherPrincipal pathology 1. Neurological pathology 2. Pulmonary pathology 3. Cardiac pathology 4. Peripheral vascular pathology 5. Hepatic pathology 6. Renal pathology 7. Pancreatic pathology 8. Gastrointestinal pathology 9. Polytrauma with abdominal lesion 10. Polytrauma without abdominal lesion 11. Burns 12. OtherSite of surgery 1. Neurosurgery 2. Thoracic 3. Cardiac 4. Peripheral vascular 5. Hepatic 6. Renal- urinary tract 7. Pancreatic 8. Gastrointestinal 9. Orthopedic 10. Other 17
    • APPENDIX 2TABLESTable 1. Gastrointestinal Failure (GIF) Score version Ipoints clinical symptomatology 0 normal GI function 1 enteral feeding < 50% of calculated needs or no feeding three days after abdominal surgery 2 food intolerance (enteral feeding not applicable due to high gastric aspirate volume, vomiting, bowel distension or severe diarrhoea) or IAH 3 food intolerance and IAH 4 abdominal compartment syndromeTable 2. Possible other versions of Gastrointestinal Failure (GIF) score. The exactweight of each point will be determined during the analysis of data. The possible ver-sions as well as the combinations of them will be tested according to the preliminary re-sults of the study.Points 0 1 2 3 4IAP (mmHg) <12 12-14 15-19 20-24 >25APP (mmHg) >60 Mean >60, Mean Mean 50-60, <50 50-60 min <50 Min <60GI symptoms none 1 symptom 2 symp- 3 symptoms 4 or more toms symptomsEnteral feeds Normal or Moderately Severely Very severe- Food intoler- mildly re- reduced reduced ly reduced ance (<5%) duced (50-80% of (20-50%) (5-20%) (>80% of daily caloric daily caloric needs needs 18
    • Table 3. APACHE II (Acute Physiology and Chronic Health Evaluation) Score Table 4. SequentialPhysiology A. Acute Organ Failure Assessment 0(SOFA) score. 1 2 3 4Core temperature (º C) 36.0-38.4 34.0-35.9 32.0-33.9 30.0-31.9 <=29.9 38,5-38,9 39,0-40,9 >= 41,0Mean Arterial Pressure (mmHg) 70-109 50-69 <= 49 110-129 130-159 >=160Heart Rate (beats/min) 70-109 55-69 40-54 <=39 110-139 140-179 >=180Breath Rate (breaths/min) 12-24 10-11 6-9 <=5 25-34 35-49 >=50Oxygenationa. If FiO2 ≥ 0,5 calculate A-aDO2=FiO2(713)-PaCO2-PaO2 <200 200-349 350-499 >= 500b. If FiO2 < 0,5 record PaO2 (mmHg) >70 61-70 55-60 < 55Arterial pH 7.33-7.49 7.25-7.32 7.15-7.24 < 7.15 7.50-7.59 7.60-7.69 >=7.70Serum Sodium (mmol/L) 130-149 120-129 111-119 <= 110 150-154 155-159 160-179 >=180Serum Potassium (mmol/L) 3.5-5.4 3.0-3.4 2.5-2.9 < 2.5 5.5-5.9 6.0-6.9 >=7.0Serum Creatinine (mmol/L) 54-129 <54 130-169 170-304 >=305Haematocrit (%) 30.0-45.9 20.0-29.9 <20 46.0-49.9 50.0-59.9 > 60WBC (x109/L) 3.0-14.9 1.0-2.9 <1.0 15.0-19.9 20.0-39.9 >= 40Glasgow Coma Scale (15 - patient`s score) B. Age points< 44 045-54 255-64 365-74 5≥ 75 6C. Chronic Health pointsNon operative or emergency postoperative 5Elective postoperative 2Liver insufficiency Biopsy proven cirrhosis. Documented portal hypertension, episodes of past upper GI bleeding attributed to portal hypertension. Prior episodes of hepatic failure / encephalopathy / coma.Cardiovascular insufficiency NYHA Class IVRespiratory insufficiency Documented chronic hypoxia, hypercapnia, secondary polycythemia , severe pulmonary hypertension (> 40 mmHg), or respirator dependency. Chronic restrictive, obstructive or vascular disease resulting in severe exercice restriction, i.e. unable to climb stairs or perform household duties.Renal insufficiency 19 Receiving chronic dialysisImmuno-depression The patient has received therapy that suppresses resistance to infection e.g. immuno-suppression, chemotherapy, radiation, long term or recent hight dose steroids, or has a disease that is sufficiently advanced to suppress resistance to infection, e.g. leukemia, lymphoma, AIDS.
    • Organ system 0 1 2 3 4Respiratory PaO2/FiO2 mmHg > 400 < 400 < 300 < 200 < 100 mechanical ventilation MV +/- MV +/- MV MVCoagulation PLT x 103 > 150 < 150 < 100 < 50 < 20Cardiovascular MAP (mmHg) > 70 < 70 Dopa <5 or Dopa >5 or Dopa>15 or Dobutamine Epi/Nor <=0.1 Epi/Nor >0.1 vasopressors mkg/kg/minCentral nervous Glasgow coma scale 15 13 - 14 10-12 6-9 <6Liver Bilirubin umol/L < 20 20-32 33-101 102-204 > 204Renal Creatinin umol/L < 110 110-170 171-299 300-440 or > 440 or urine output <500mL/day <200mL/day 20
    • Table 5. Clinical conditions associated with risk of IAH (immediate prior ICUadmission or during the first 24 h in ICU)A. Related to diminished abdominal wall compliance - Acute respiratory failure - Abdominal (incl. vascular) surgery with primary fascial or tight closure - Major trauma/burns - Prone positioning or head of bed elevated >30 degreesB. Related to increased intra-luminal contents - gastroparesis - ileus - colonic pseudo-obstruction - Damage control laparotomyC. Related to increased abdominal contents - Ascites/liver failure - Haemoperitoneum/PneumoperitoneumD. Related to capillary leak and fluid resuscitation - Acidosis (pH below 7.2) - Hypothermia (core temperature below 33°C) - Polytransfusion (> 10 units of packed red cells / 24 hours) - Coagulopathy (platelet count below 50000/mm3 OR an activated partial thromboplastin time (APTT) more than 2 times normal OR a prothrombin time (PTT) below 50% OR an international standardised ratio (INR) more than 1.5) - Massive fluid resuscitation (> 5 liters / 24 hrs) - Oliguria 21