SUP-ICU Trial
Research type
Research Study
Full title
Stress ulcer prophylaxis with proton pump inhibitor (pantoprazole) in adult critically ill patients in the intensive care unit: a randomised, blinded, placebo-controlled trial (Stress Ulcer Prophylaxis in the Intensive Care Unit SUP-ICU trial)
IRAS ID
188732
Contact name
Matt Wise
Contact email
Sponsor organisation
Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet
Eudract number
2015-000318-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
In critically ill patients it has long been recognised that there is an increased incidence of bleeding into the gut which is due to ulceration of the gut lining (stress ulcers). It is now standard practice to use drugs which reduce acid secretion in the stomach to prevent stress ulcers and bleeding. Termed stress ulcer prophylaxis (SUP), these drugs are either histamine-2 receptor antagonists (commonly rantidine) or proton pump inhibitors (PPIs). The majority of intensive care units use PPIs started on admission in patients at high risk of bleeding, usually those who are mechanically ventilated via a breathing machine. However, the trials which demonstrated a reduction in bleeding with SUP are >20 years old and had a high risk of bias. A recent systematic review and meta-analysis showed no benefit of SUP compared to placebo. SUP may also be associated with untoward effects such as infections (pneumonia, Clostridium difficile diarrhoea) or an increase in cardiovascular events. The current trial therefore aims to assess if SUP offers a benefit over placebo. The primary outcome measure is death at 90 days, with secondary outcomes of bleeding and adverse events including infections and cardiovascular events.
REC name
Wales REC 3
REC reference
16/WA/0315
Date of REC Opinion
9 Dec 2016
REC opinion
Further Information Favourable Opinion