Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Patients who are critically ill in the in the Intensive Care Unit (ICU), especially those who
need a breathing machine, can develop ulcers in the stomach that bleed. To prevent bleeding,
many such patients around the world receive a drug called pantoprazole that decreases acid
production. However, today, compared to decades ago, critically ill patients rarely develop
gastrointestinal bleeding. This decrease is likely due to modern medicine, better
resuscitation and earlier feeding. There may also be harms associated with pantoprazole and
other drugs that reduce acid levels in the stomach including lung infections (pneumonia) and
bowel infections (clostridium difficile). Studies in this area are old and of modest quality.
Therefore, it is difficult to know whether pantoprazole does decrease stomach bleeding these
days, or whether the possible harms of lung and bowel infections are actually more common and
more serious problems. The goal of this international study is to determine if, in critically
ill patients using breathing machines, the use of pantoprazole is effective in preventing
bleeding from stomach ulcers or whether it causes more problems such as lung infection
(pneumonia) and bowel infection (Clostridium difficile), or whether pantoprazole has no
effect at all. Whether the harms are worth the benefits, and whether the benefits are worth
the costs, will be determined by an economic analysis to inform patients, families,
clinicians, and healthcare systems globally.
Phase:
Phase 3
Details
Lead Sponsor:
McMaster University
Collaborators:
Australian and New Zealand Intensive Care Society Clinical Trials Group Canadian Critical Care Trials Group Canadian Institutes of Health Research (CIHR) National Health and Medical Research Council, Australia