Pantoprazole for Gastrointestinal Bleeding
(REVISE Trial)

Recruiting in Palo Alto (17 mi)

+74 other locations

Overseen byDeborah Cook, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: McMaster University

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Deborah Cook, MD

Principal Investigator

McMaster University

Eligibility Criteria

The REVISE trial is for adults over 18 in the ICU on a ventilator, expected to remain so for at least two more days. It's not for those with severe liver disease, certain drug treatments (HIV protease inhibitors, high-dose methotrexate), or who've been on mechanical ventilation for over 72 hours. Pregnant women and patients already treated with similar drugs are excluded.

Inclusion Criteria

Age 18 years or more

Receiving invasive mechanical ventilation in an ICU and in the opinion of the treating ICU physician mechanical ventilation will not be discontinued before the end of the day after tomorrow.

Exclusion Criteria

The treating clinician considers either Pantoprazole or placebo are indicated or contraindicated for this patient

Pantoprazole contraindicated for patient due to local product information (Australia/New Zealand)

Being treated with HIV protease inhibitors atazanavir or nelfinavir (Australia/New Zealand)

See 12 more

Treatment Details

Interventions

Pantoprazole (Proton Pump Inhibitor)
Placebo (0.9% saline) (Other)

Trial OverviewThis study tests if pantoprazole prevents stomach ulcers and bleeding in critically ill ventilated patients versus a saline placebo. The aim is to see if pantoprazole reduces such bleeding without causing lung or bowel infections, compared to no treatment.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Stress Ulcer Prophylaxis (Pantoprazole)Active Control1 Intervention

pantoprazole 40mg powder for injection reconstituted with 0.9% saline

Group II: Placebo (0.9% saline)Placebo Group1 Intervention

Withholding Stress ulcer prophylaxis (intravenous 0.9% saline as placebo)

Pantoprazole is already approved in Canada, Japan, China, Switzerland for the following indications: