NCT02467621

Stress Ulcer Prophylaxis in the Intensive Care Unit

Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,350 (actual)
• Sponsor: Dr. Morten Hylander Møller · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Bleeding
• Stress Ulcers

Interventions

Type	Name	Description
DRUG	Pantoprazole	40 mg x 1 daily intravenously from ICU admission to ICU discharge
OTHER	Saline (0.9%)	10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-10-22
• Completion: 2018-01-21
• First posted: 2015-06-10
• Last updated: 2022-11-15
• Results posted: 2019-06-07

Locations

33 sites across 6 countries: Denmark, Finland, Netherlands, Norway, Switzerland, United Kingdom