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

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.

Conditions

• Gastrointestinal Hemorrhage (Clinically Important, Upper)

Interventions

DRUG

Placebo (0.9% saline)

normal saline

DRUG

Pantoprazole

40 mg powder for injection reconstituted with 0.9% saline

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Canadian Critical Care Trials Group

  collaborator OTHER

• Australian and New Zealand Intensive Care Society Clinical Trials Group

  collaborator NETWORK

• National Health and Medical Research Council, Australia

  collaborator OTHER

• McMaster University

  lead OTHER

Principal Investigators

• Deborah Cook, MD · McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-09

Primary Completion

2023-10-31

Completion

2024-01-31

FDA Drug

Yes

Countries

• United States
• Australia
• Brazil
• Canada
• Kuwait
• Pakistan
• Saudi Arabia
• United Kingdom

Study Locations