Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU)
Overview
- Phase
- Phase 4
- Intervention
- Pantoprazole
- Conditions
- Gastrointestinal Bleeding
- Sponsor
- Dr. Morten Hylander Møller
- Enrollment
- 3350
- Locations
- 33
- Primary Endpoint
- Mortality
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however the quantity and quality of evidence is low and potential harm has been reported.
The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton pump inhibitor in adult critically ill patients in the ICU.
Detailed Description
Critically ill patients in the ICU are at risk of stress related gastrointestinal (GI) bleeding, and SUP is recommended. However, the quantity and quality of evidence supporting SUP is low and has been questioned. Furthermore studies have shown that proton pump inhibitors (PPIs) may increase the risk of pneumonia, clostridium difficile infection and acute myocardial ischemia. The aim of the SUP-ICU trial is to assess the benefits and harms of SUP with PPI in adult critically ill patients in the ICU.
Investigators
Dr. Morten Hylander Møller
Principal investigator
Scandinavian Critical Care Trials Group
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Proton pump inhibitor (PPI)
Pantoprazole 40 mg
Intervention: Pantoprazole
Normal saline
Saline (0.9%)
Intervention: Saline (0.9%)
Outcomes
Primary Outcomes
Mortality
Time Frame: 90 days
Landmark mortality 90-days after randomization
Secondary Outcomes
- Number of Participants With Clinically Important GI Bleeding(Until ICU discharge, maximum 90 days)
- Number of Serious Adverse Reactions(Until ICU discharge, maximum 90 days)
- Percentage of Days Alive Without Organ Support(Within 90 days)
- Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia(Until ICU discharge, maximum 90 days)
- Number of Participants With One or More Infectious Adverse Events(Until ICU discharge, maximum 90 days)
- Mortality(1 year)
- A Health Economic Analysis(90 days)