NCT03374800: REVISE

Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial

Completed Phase 3 Last updated 20 September 2024

What this trial tests

Phase 3 trial testing Placebo (0.9% saline) in Gastrointestinal Hemorrhage (Clinically Important, Upper) in 4,800 participants. Completed in 31 January 2024.

Timeline

9 July 2018

Primary endpoint
31 October 2023

31 January 2024

Quick facts

Lead sponsor	McMaster University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	4,800
Start date	9 July 2018
Primary completion	31 October 2023
Estimated completion	31 January 2024
Sites	67 locations across Pakistan, Saudi Arabia, United Kingdom, Canada, Australia, Kuwait, United States, Brazil

Drugs / interventions tested

• Placebo (0.9% saline)
• Pantoprazole (pantoprazole) — full drug profile →

Conditions studied

• Gastrointestinal Hemorrhage (Clinically Important, Upper) — all drugs for Gastrointestinal Hemorrhage (Clinically Important, Upper) →

Sponsor

McMaster University

Who can join

18 and older, any sex, with Gastrointestinal Hemorrhage (Clinically Important, Upper). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation.
   Cook D, Deane A, Lauzier F, Zytaruk N, et al · · 2024 · cited 55× · PMID 38875111 · DOI 10.1056/nejmoa2404245
2. REVISE: <i>R</i>e-<i>Ev</i>aluating the <i>I</i>nhibition of <i>S</i>tress <i>E</i>rosions in the ICU: a randomised trial protocol.
   Deane AM, Alhazzani W, Guyatt G, Finfer S, et al · · 2023 · cited 14× · PMID 37968012 · DOI 10.1136/bmjopen-2023-075588
3. Barriers, Solutions, and Opportunities for Adapting Critical Care Clinical Trials in the COVID-19 Pandemic.
   Cook D, Taneja S, Krewulak K, Zytaruk N, et al · · 2024 · cited 5× · PMID 38995645 · DOI 10.1001/jamanetworkopen.2024.20458
4. Special Announcement: Guidelines to the Practice of Anesthesia-Revised Edition 2023.
   Dobson GR. · · 2023 · cited 5× · PMID 36690904 · DOI 10.1007/s12630-022-02367-1
5. REVISE: re-evaluating the inhibition of stress erosions in the ICU-statistical analysis plan for a randomized trial.
   Heels-Ansdell D, Billot L, Thabane L, Alhazzani W, et al · · 2023 · cited 4× · PMID 38057875 · DOI 10.1186/s13063-023-07794-z
6. Protocol implementation during the COVID-19 pandemic: experiences from a randomized trial of stress ulcer prophylaxis.
   Dennis B, Deane A, Lauzier F, Zytaruk N, et al · · 2024 · cited 3× · PMID 38704520 · DOI 10.1186/s12874-024-02233-2
7. Adjudication of a primary trial outcome: Results of a calibration exercise and protocol for a large international trial.
   Cook D, Deane A, Dionne JC, Lauzier F, et al · · 2024 · cited 2× · PMID 38559746 · DOI 10.1016/j.conctc.2024.101284
8. Proton pump inhibitors in critically ill mechanically ventilated patients with COVID-19: protocol for a substudy of the Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial.
   Dennis BB, Thabane L, Heels-Ansdell D, Dionne JC, et al · · 2023 · cited 2× · PMID 37644556 · DOI 10.1186/s13063-023-07589-2