CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,800 enrolled
Drug / intervention
Placebo (0.9% saline) +1 moredrug
Likely dose
Pantoprazole 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03374800
NCT03374800Phase 3Completed

Re-EValuating the Inhibition of Stress Erosions: Prophylaxis Against Gastrointestinal Bleeding in the Critically Ill (The REVISE) Trial

McMaster University·interventional·Posted Dec 15, 2017·Updated Sep 20, 2024

In Brief

A Phase 3 clinical trial evaluating Placebo (0.9% saline) and Pantoprazole for Gastrointestinal Hemorrhage (Clinically Important, Upper). Completed, enrolled 4,800 participants across 67 sites in 8 countries.

Detailed 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 upper 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 (Clostridioides 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 (Clostridioides 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Brazil, Canada, Kuwait, Pakistan, Saudi Arabia, United Kingdom, United States

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedDec 15, 2017
Enrollment StartJul 9, 2018
Primary CompletionOct 31, 2023
Study CompletionJan 31, 2024
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 8.5 years ago

Interventions

Placebo (0.9% saline)drug

normal saline

Pantoprazoledrug

40 mg powder for injection reconstituted with 0.9% saline