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Proton Pump Inhibitor

Pantoprazole for Gastrointestinal Bleeding (REVISE Trial)

Phase 3
Waitlist Available
Led By Deborah Cook, MD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days (in the icu, censored at 90 days)
Awards & highlights

REVISE Trial Summary

This trial is testing whether a drug called pantoprazole decreases acid production in the stomach to prevent ulcers and bleeding in ICU patients who need breathing machines. The trial will also study whether pantoprazole has any harmful effects, such as lung or bowel infections.

Who is the study for?
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.Check my eligibility
What is being tested?
This 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.See study design
What are the potential side effects?
Potential side effects of pantoprazole may include an increased risk of lung infections like pneumonia and bowel infections such as Clostridium difficile.

REVISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days (in the icu, censored at 90 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days (in the icu, censored at 90 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Safety Outcome: 90 Day Mortality
Rate of clinically important upper gastro-intestinal bleeding
Secondary outcome measures
New initiation of treatment with renal replacement therapy in ICU
Rate of Clostridioides difficile associated infection
Rate of ICU mortality
+3 more
Other outcome measures
Duration of mechanical ventilation (days)
Hospital length of stay (days)
ICU length of stay (days)
+2 more

REVISE Trial Design

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)

Find a Location

Who is running the clinical trial?

Australian and New Zealand Intensive Care Society Clinical Trials GroupNETWORK
13 Previous Clinical Trials
39,670 Total Patients Enrolled
National Health and Medical Research Council, AustraliaOTHER
165 Previous Clinical Trials
470,337 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,448,714 Total Patients Enrolled

Media Library

Pantoprazole (Proton Pump Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03374800 — Phase 3
Upper Gastrointestinal Bleeding Research Study Groups: Stress Ulcer Prophylaxis (Pantoprazole), Placebo (0.9% saline)
Upper Gastrointestinal Bleeding Clinical Trial 2023: Pantoprazole Highlights & Side Effects. Trial Name: NCT03374800 — Phase 3
Pantoprazole (Proton Pump Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03374800 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other scientific papers have been published about Stress Ulcer Prophylaxis (Pantoprazole)?

"Stress Ulcer Prophylaxis (Pantoprazole) was first observed in 2008 at National Taiwan University Hospital. So far, there have been 109 completed studies with 13 more currently underway. Many of these active clinical trials are based in Kitchener, Alberta."

Answered by AI

How does Pantoprazole help patients with stress ulcers?

"While commonly used to treat erosive esophagitis, Pantoprazole (Stress Ulcer Prophylaxis) can also help those who have gastroesophageal reflux disease and require a reduction in gastric acid secretion."

Answered by AI

How many total people are enrolled in this experiment?

"Indeed, the clinical trial is ongoing and is recruiting patients as of October 19th, 2022. The trial was initially posted on July 9th, 2018 and has 45 different sites. The aim is to enroll 4800 people in total."

Answered by AI

What is the goal of this medical study?

"The primary objective of this study is to assess the 90-day mortality rate of patients. Secondary objectives include the rate of important gastrointestinal (GI) bleeding in ICU or resulting in ICU readmission, the rate of Clostridium difficile associated infection, and the rate of ventilator associated pneumonia (VAP) in ICU."

Answered by AI

Could you explain the potential risks of taking Pantoprazole for stress ulcer prevention?

"There is some efficacy data and multiple rounds of safety data, meaning that Stress Ulcer Prophylaxis (Pantoprazole) is likely safe and received a score of 3."

Answered by AI

Where are the different sites where this study is taking place?

"There are 45 sites enrolling patients in this study, which are located in cities including Kitchener, North York, and Toronto. Patients are encouraged to choose the site closest to them to reduce the amount of travel required."

Answered by AI

Is this clinical trial currently looking for more participants?

"Clinicaltrials.gov reports that this clinical trial is open and presently recruiting individuals. The study was originally posted on 2018-07-09 with the most recent update being on 2022-10-19."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial
2018. "Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03374800.
~711 spots leftby May 2025
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