Stress Ulcer Prophylaxis in the Intensive Care Unit
- Conditions
- Gastrointestinal BleedingStress Ulcers
- Interventions
- Other: Saline (0.9%)
- Registration Number
- NCT02467621
- Lead Sponsor
- Dr. Morten Hylander Møller
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal saline Saline (0.9%) Saline (0.9%) Proton pump inhibitor (PPI) Pantoprazole Pantoprazole 40 mg
- Primary Outcome Measures
Name Time Method Mortality 90 days Landmark mortality 90-days after randomization
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinically Important GI Bleeding Until ICU discharge, maximum 90 days Number of participants with one or more episodes of clinically important GI bleeding in the ICU
Number of Serious Adverse Reactions Until ICU discharge, maximum 90 days Serious adverse reactions are: anaphylactic reactions, agranulocytosis, pancytopenia, acute hepatic failure, Steven Johnsons Syndrome and toxic epidermal necrolysis, interstitial nephritis and angioedema.
Percentage of Days Alive Without Organ Support Within 90 days Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia Until ICU discharge, maximum 90 days Composite outcome of the number of participants with one or more of the mentioned conditions in the ICU
Number of Participants With One or More Infectious Adverse Events Until ICU discharge, maximum 90 days Number of participants with one or more episodes of pneumonia or clostridium difficile infection in the ICU
Mortality 1 year Data for landmark mortality 1 year after randomization.
A Health Economic Analysis 90 days This has not been completed yet.
Trial Locations
- Locations (33)
Dept. of Intensive Care, Aalborg University Hospital
🇩🇰Aalborg, Denmark
Dept. of Intensive Care, Århus University Hospital Nørrebrogade
🇩🇰Aarhus, Denmark
Dept. of Intensive Care, Århus University Hospital Skejby
🇩🇰Arhus, Denmark
Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet
🇩🇰Copenhagen, Denmark
Dept. of Neurointensive Care, Copenhagen University Hospital Rigshospitalet
🇩🇰Copenhagen, Denmark
Dept. of Intensive Care, Bispebjerg Hospital
🇩🇰Copenhagen, Denmark
Dept. of Intensive Care, Copenhagen University Hospital Herlev
🇩🇰Herlev, Denmark
Dept. of Intensive Care, Herning Hospital
🇩🇰Herning, Denmark
Dept. of Intensive Care, Hillerød Hospital
🇩🇰Hillerød, Denmark
Dept. of Intensive Care, Hjørring Hospital
🇩🇰Hjørring, Denmark
Scroll for more (23 remaining)Dept. of Intensive Care, Aalborg University Hospital🇩🇰Aalborg, Denmark