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Table 2 Overview of study outcomes

From: Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial

  Indicator Timeline
Primary outcome Mortality 90 days
Secondary outcomes
 Logistical Days free of ICU 30 days
Days free of ventilation 30 days
Days free of RRTa 30 days
Days free of hospital 30 days
 Physiological APACHE IIb scores Up to 30 daysc
SOFAd scores Up to 30 daysc
Pa02/Fi02e ratios Up to 30 daysc
ARDSf scores Up to 30 daysc
 Safety Enterocutaneous fistula 30 days
ACSg and/or severe IAHh 30 days
Intra-abdominal abscess 30 days
 Biological Il-6 Up to 30 daysi
IL-10 Up to 30 daysi
Procalcitonin Up to 30 daysi
Activated protein C Up to 30 daysi
High mobility group box protein 1 Up to 30 daysi
Mitochondrial DNA Up to 30 daysi
C3a and C5a Up to 30 daysi
 Microbiological Intra-abdominal Up to 30 daysj
Microbiological cultures  
 Mass cytometry Intra-peritoneal inflammatory cells Up to 30 daysk
 Economic Micro-costed resource consumption 1 year
 Quality of life Euroqol EQ-5D-5L 90 days and 1 year
SF-36 90 days and 1 year
  1. aRRT renal replacement therapy
  2. bAcute Physiology and Chronic Health Evaluation Score
  3. cMeasured daily using the worst value of that day
  4. dSOFA Sequential Organ Failure Assessment
  5. ePa0 2 /Fi0 2 partial pressure of oxygen over inspired fraction of oxygen
  6. fARDS Acute Respiratory Distress Syndrome
  7. gACS Abdominal Compartment Syndrome
  8. hIAH intraabdominal hypertension
  9. iMeasured as per Table 3
  10. jMeasured as clinically indicated by the treating team
  11. kMeasured on intra-peritoneal fluid obtained in Calgary