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NCT03374800 · ClinicalTrials.gov registry record · Phase 3
Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial
A Phase 3 study of Gastrointestinal Hemorrhage (Clinically Important, Upper), sponsored by McMaster University.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,800
- Enrollment target
- 20
- Study locations
NCT03374800 is a Phase 3 study of Gastrointestinal Hemorrhage (Clinically Important, Upper) that has completed, run by McMaster University. The registered enrollment target is 4,800 participants. The trial reports 20 study locations across 5 states.
The verdict
NCT03374800, a Phase 3 study of Gastrointestinal Hemorrhage (Clinically Important, Upper), has completed, sponsored by McMaster University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,800 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo (0.9% saline)
- DRUG Pantoprazole
Study Locations (20)
New South Wales
- Bankstown-Lidcombe Hospital - Bankstown
- Blacktown Hospital - Blacktown
- Sutherland Hospital - Caringbah
- Gosford Hospital - Gosford
- Nepean Hospital - Kingswood
- St George Hospital - Kogarah
- Royal North Shore Hospital - Saint Leonards
- Wollongong Hospital - Wollongong
Victoria
- Bendigo Health - Bendigo
- Geelong University Hospital - Geelong
- Austin Hospital - Heidelberg
- Alfred Hospital - Melbourne
- Royal Melbourne Hospital - Melbourne
- Epworth Hospital - Melbourne
Queensland
- Royal Brisbane Womens Hospital - Brisbane
- Ipswich Hospital - Ipswich
- Mater Hospital - South Brisbane
- Princess Alexandra Hospital - Woolloongabba
Nebraska
- University of Nebraska - Nebraska Medical Center - Omaha
South Australia
- Royal Adelaide Hospital - Adelaide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,800 participants |
| Start Date | 2018-07-09 |
| Est. Completion | 2024-01-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03374800
The ClinicalTrials.gov registry entry for NCT03374800 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is McMaster University, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gastrointestinal Hemorrhage (Clinically Important, Upper) appearing as the primary indexed condition, and to 2 interventions - of which Placebo (0.9% saline) is the first listed.
NCT03374800 reports 20 study locations spanning 5 distinct geographic areas - top geographies include New South Wales, Victoria, Queensland.
Frequently Asked Questions
What is clinical trial NCT03374800 about?
NCT03374800 is a clinical study titled "Re-EValuating the Inhibition of Stress Erosions (REVISE) 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, t...
What is the current status of trial NCT03374800?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,800 participants. The study started on 2018-07-09. Estimated completion is 2024-01-31.
What conditions does trial NCT03374800 study?
This clinical trial studies the following conditions: Gastrointestinal Hemorrhage (Clinically Important, Upper).
What interventions are being tested in trial NCT03374800?
The interventions under investigation include: Placebo (0.9% saline) (DRUG), Pantoprazole (DRUG).
Who is sponsoring clinical trial NCT03374800?
This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03374800 being conducted?
This trial has 20 study locations across Nebraska, New South Wales, Queensland, South Australia, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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