Prospective, Observational, Multicenter Study of

Gastrointestinal Dysfunction in Critically Ill Patients.

Development of Gastrointestinal Failure Score.

Study protocolDate: 16/04/2009 10:00AM

Template as developed by the

Clinical Trials Workgroup

Of the

World Society of the Abdominal Compartment

Syndrome

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PART A. Summary of the study

Principal investigators:

Joel Starkopf MD, PhD

University of Tartu, Tartu, Estonia

Tartu University Clinics, Tartu, Estonia

Manu Malbrain, MD, PhD

ZNA Stuivenberg

Antwerpen, Belgium

Martin Björck, MD, PhD

Uppsala University Hospital

Uppsala, Sweden

Annika Reintam MD, PhD

University of Tartu, Tartu, Estonia

Study 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

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Objectives

Primary 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 design

Prospective, observational, multicenter study

Patient population

Consecutive adult mechanically ventilated patients, admitted to the participating ICU-s during one week of study period.

Duration of the study period

For the individual patient

1. Study period 7 days

2. Follow-up period of 28 days

Endpoints

Primary endpoint

Prognostication of 28 days mortality in adult mechanically ventilated intensive care

patients.

Secondary endpoints

Evaluation of the prognostic value of GIF sub-score in combination with SOFA score.

Identification of the incidence of GI symptoms, food intolerance/underfeeding and IAH

among mechanically ventilated, adult intensive care patients.

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PART B. Study protocol

1. INTRODUCTION

1.1 Background

Various symptoms of gastrointestinal (GI) dysfunction – diarrhoea, decreased bowel sounds, abdominal distension, etc. – are frequent in critically ill patients [1]. Food intolerance is evident in 46% to 57% of ICU patients [2,3,4]. Intra-abdominal hypertension (IAH), defined as sustained intra-abdominal pressure (IAP) above 12 mmHg, occurs in 50% and abdominal compartment syndrome (IAP > 20 mmHg with onset of new organ failure) in 8% of ICU patients of mixed population [5]. Significant impact 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 has existed for several decades [8,9]. Even though the GI tract was called “the motor of organ failure” [10], gastrointestinal failure (GIF) itself is not routinely assessed as a part of multiorgan failure (MOF). For complex evaluation of all vital organs, several scoring systems for MOF have developed. The GI system, however, is not included in any of the scores (APACHE; SOFA, etc) widely used today. To characterize GI function in critically ill patients, we have proposed a new GIF score, which combines food intolerance and IAH into one grading system (Table 1) [11]. Preliminary, single-centre prospective study demonstrated high prognostic value of this score [12]. This particular score, however, has important limitation such as the estimation of food intolerance, which may be observer dependent. Another potential problem is that the variables in the score may not represent truly continuous variables [13]. Therefore, in the present study the 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 of dynamics of organ failure and to assess the effects of therapeutic interventions on its course. Future usage of the GIF-score together with SOFA-score would allow better understanding of interrelation between the failures of the various organs.

1.2. Rationale for the study

Present 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 ICU during 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, food intolerance/underfeeding and IAP/APP will be documented. The patients will thereafter be 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 grade GIF score, build up of which follows the logic of organ failure sub-scores in SOFA score. The following analysis will investigate the predictive power of a possible GIF score variants on mortality, and thereby makes it possible to identify the best GIF score.

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If the GIF score will appear highly predictive for ICU mortality, it can be suggested as a standardized measurement tool in interventional studies, investigating strategies aimed to improve GI function in critically ill patients.

2. STUDY OBJECTIVES

Primary 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 PROCEDURES

3.1. Overall design

This is a prospective, observational, multicenter study, designed to validate the GIF score in adult, and mechanically ventilated, ICU patients. Consecutive adult mechanically ventilated patients, admitted to the participating ICU-s during one week of study period will be enrolled. Approval of local ethic committee will be obtained prior study initialization.

The study will consist of three phases:

1. Screening assessment, documentation of admission parameters

2. Study period of 7 days

3. Follow-up period of 28 days

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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 collection

The 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 calories

2. 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

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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 in every 6 hrs. When intermittent measurements are performed they can either be with the modified Kron’s method (instillation of 25 ml) or with the Foley Manometer method. Pressure measurements technique should be in accordance with the Guidelines of World Society on Abdominal Compartment Syndrome [15].

Mean arterial pressure will be documented at the same time with IAP measurement for calculation 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 > 20mmHg with 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, food intolerance/underfeeding and/or IAP into five-graded scale. The possible examples are provided in Table 1 and Table 2. The best score will be determined with the ultimate aim to find a score, which allows the best prediction of ICU outcome.

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5. Sequential Organ Failure Assessment (SOFA) score

The score is based on serial assessment of respiratory, coagulation, cardiovascular, central nervous, liver and renal function, Appendix 2 [16]. The worst recordings from last 24 hours will accounted for calculations. The sub-scores for each organ system will be documented. For scoring, the following blood analyses, at least once daily, are necessary:

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)

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Follow-up period – day 7 to 28

Follow-up period lasts until 28 days after enrolment. At the end of this period, the following data are recorded by ticking in CRF

1. Survival

2. The decision of withdrawal/withholding the treatment will be documented, if taken

3. 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.

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3.2. Selection of the study population

All patients, consequently admitted to the participating ICU during the study week, will be screened for study inclusion.

3.2.2. Inclusion criteria

For 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 years

3. Mechanical ventilation started at the day of admission or earlier and expected to be continued for at least 6 hours

4. Possibility to implement intra-abdominal pressure monitoring via bladder

5. 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 years

2. Spontaneous ventilation, or mechanical ventilation for less than 6 hours

3. Intra-abdominal pressure monitoring not applicable for any reason

3.2.4. Sample size calculation

Since this study is epidemiological no sample size calculation may be performed

3.3. Rationale for the study design

Prospective, multicenter study would be the only opportunity to create the best score

widely applicable for ICU patients.

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4. STUDY MEASUREMENTS AND ENDPOINTS

4.1. Primary endpoint

Prognostication of 28-day survival.

4.2. Screening and demographic measurements

The 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

4.3.3 Presence or absence of abdominal compartment syndrome (yes/no, primary/secondary) during the last 24 hours

4.3.4 Feeding during last 24 hours

The calculated requirements according to Harris-Benedict equation

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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 24 hours:

For each variable the presence of it is marked, and whether the presence of this variable is the reason for the reduction of enteral feeding. Several reasons may be marked for the 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)

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4.3.6 Medications and procedures used during the previous 24 hours

to 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 automatically

For scoring, the following blood analyses (at least once in days 1 ,2 ,4 and 6) are necessary:

arterial blood gases

platelet count

serum bilirubin

serum creatinin

For 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)

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4.4. Primary endpoint and method of assessment.

Univariate analyses of admission parameters will be applied to identify the risk factors

for 28-days mortality. Parameters with p<0.2 are thereafter entered into the multiple

logistic regression model to identify the independent risk factors. The impact of different

variations 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 value

of first three days SOFA score alone or in combination with the best GIF sub-score on

28-day mortality.

5. DATA MANAGEMENT AND STATISTICS

Electronic case report forms will be provided for the recording of the data.

Statistical analysis

Data analysis

General linear model and the Receiver Operating Characteristics (ROC) curves will be used for evaluation of prognostic value of GIF score.

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6. REFERENCES.

1. Dark DS, Pingleton SK. Nonhemorrhagic gastrointestinal complications in acute respiratory failure. Crit Care Med. 1989; 17(8): 755-8

2. 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): 1955-61

3. 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): 796-800

4. Chang RW, Jacobs S, Lee B. Gastrointestinal dysfunction among intensive care unit patients. Crit Care Med. 1987; 15(10): 909-14

5. 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): 822-9

6. 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): 315-22

7. Reintam A, Parm P, Kern H, Starkopf J. Impact of intraabdominal pressure on ICU mortality. Intensive Care Med. 2005; 31, Suppl 1: S8

8. Carrico CJ, Meakins JL, Marshall JC, Fry D, Maier RV. Multiple organ failure syndrome. Arch Surg. 1986; 121: 196-208

9. 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: 33-37

10. Wiest R, Rath HC. Bacterial translocation in the gut. Best Practice & Research Clinical Gastroenterology. 2003; 17(3): 397-425

11. 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):818-29

15. Malbrain ML, Cheatham ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppaniemi A, Olvera C, Ivatury R, D'Amours 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

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APPENDIX 1

DEFINITIONS

Profile 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 operation

Intra-abdominal hypertension (IAH) is defined as sustained IAP 12mmHg

Abdominal Compartment Syndrome (ACS) is defined as sustained IAP > 20mmHg with new organ failure

Severity of infection will be evaluated according to the Surviving Sepsis Guidelines/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 resuscitation

CODES

Reason 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

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In case of shock please state

1. Septic shock

2. Cardiogenic shock

3. Hemorrhagic shock

4. Hypovolemic shock

5. Anaphylactic shock

6. Mixed

7. Other

Principal 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. Other

Site 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

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APPENDIX 2

TABLES

Table 1. Gastrointestinal Failure (GIF) Score version I

points 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 syndrome

Table 2. Possible other versions of Gastrointestinal Failure (GIF) score. The exact weight 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 4

IAP (mmHg) <12 12-14 15-19 20-24 >25

APP (mmHg) >60 Mean >60,

Min <60

Mean 50-60

Mean 50-60, min <50

<50

GI symptoms none 1 symptom 2 symp-toms

3 symptoms 4 or more symptoms

Enteral feeds Normal or mildly re-duced (>80% of daily caloric needs

Moderately reduced (50-80% of daily caloric needs

Severely reduced (20-50%)

Very se-verely re-duced (5-20%)

Food intol-erance (<5%)

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A. Acute Physiology 0 1 2 3 4

Core 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 >= 41,0

Mean Arterial Pressure (mmHg)

70-109 50-69 <= 49

110-129 130-159 >=160

Heart Rate (beats/min)

70-109 55-69 40-54 <=39

110-139 140-179 >=180

Breath Rate (breaths/min)

12-24 10-11 6-9 <=5

25-34 35-49 >=50

Oxygenation

a. If FiO2 ≥ 0,5 calculate A-aDO2=FiO2(713)-PaCO2-PaO2

b. If FiO2 < 0,5 record PaO2 (mmHg)

<200 200-349 350-499 >= 500

>70 61-70 55-60 < 55

Arterial pH

7.33-7.49 7.25-7.32 7.15-7.24 < 7.15

7.50-7.59 7.60-7.69 >=7.70

Serum Sodium (mmol/L)

130-149 120-129 111-119 <= 110

150-154 155-159 160-179 >=180

Serum 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 >=7.0

Serum Creatinine (mol/L)

54-129 <54

130-169 170-304 >=305

Haematocrit (%)

30.0-45.9 20.0-29.9 <20

46.0-49.9 50.0-59.9 > 60

WBC (x109/L)

3.0-14.9 1.0-2.9 <1.0

15.0-19.9 20.0-39.9 >= 40

Glasgow Coma Scale (15 - patient`s score)

B. Age points

< 44 0

45-54 2

55-64 3

65-74 5

≥ 75 6

C. Chronic Health points

Non operative or emergency postoperative 5

Elective postoperative 2

Liver 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 IV

Respiratory 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 Receiving chronic dialysis

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Immuno-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.

Table 3. APACHE II (Acute Physiology and Chronic Health Evaluation) Score

Table 4. Sequential Organ Failure Assessment (SOFA) score.

Organ system 0 1 2 3 4

Respiratory PaO2/FiO2 mmHg > 400 < 400 < 300 < 200 < 100

mechanical ventilation MV +/- MV +/- MV MV

Coagulation PLT x 103 > 150 < 150 < 100 < 50 < 20

Cardiovascular MAP (mmHg) > 70 < 70 Dopa <5 or Dobutamine

Dopa >5 or Epi/Nor <=0.1

Dopa>15 or Epi/Nor >0.1

vasopressors mkg/kg/min

Central nervous Glasgow coma scale 15 13 - 14 10-12 6-9 < 6

Liver Bilirubin umol/L < 20 20-32 33-101 102-204 > 204

Renal Creatinin umol/L < 110 110-170 171-299 300-440 or > 440 or

urine output <500mL/day <200mL/day

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Table 5. Clinical conditions associated with risk of IAH (immediate prior ICU

admission 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 degrees

B. Related to increased intra-luminal contents

- gastroparesis

- ileus

- colonic pseudo-obstruction

- Damage control laparotomy

C. Related to increased abdominal contents

- Ascites/liver failure

- Haemoperitoneum/Pneumoperitoneum

D. 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

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