REVISE
Research type
Research Study
Full title
Re-Evaluating the Inhibition of Stress Erosions: Gastrointestinal Bleeding Prophylaxis in ICU
IRAS ID
278077
Contact name
Marlies Ostermann
Contact email
Sponsor organisation
St. Joseph’s Healthcare, McMaster University
Eudract number
2020-000483-27
Duration of Study in the UK
3 years, 1 months, 1 days
Research summary
When patients are critically ill, they have an increased risk of developing a stress ulcer in the gut. Sometimes, the ulcers can bleed and patients may need a blood transfusion or other treatments to stop the bleeding. It is common practice to give patients medications like proton pump inhibitors (PPIs) with the aim to prevent these bleeding complications. Despite several studies in the past, it remains unclear whether these medications are effective. There is also concern that these medications may increase the risk of pneumonia, bowel infections and kidney failure.
Together with experts across the world, we would like to do a large study to find out whether PPIs are effective and safe. We plan to study 4800 patients who are critically ill in the Intensive Care Unit and receiving treatment with the breathing machine. Randomly, one half of patients will be given a PPI daily and the other half will be given placebo (dummy medication). We will test whether the daily use of PPIs prevents bleeding from an ulcer in the gut and whether there is a risk of pneumonia, bowel infections, kidney failure or dying. Patients who are known to have a high risk of bleeding will be excluded from taking part. In the current COVID-19 pandemic, we are particularly interested in exploring the role of PPI treatment in this cohort.
The study will last while patients are in ICU up to 90 days or until treatment with the breathing machine has been stopped for >48 hours, bleeding from the stomach has developed, or the patient dies.The study is called REVISE. It will be led by experts from across the world in collaboration with the Canadian Critical Care Trials Group, the Australian and New Zealand Critical Care Trials Group and the International Forum for Acute Care Trialists.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0221
Date of REC Opinion
20 Aug 2020
REC opinion
Further Information Favourable Opinion