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Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial
NCT03374800 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03374800 reports 20 study locations spanning 5 distinct geographic areas — top geographies include New South Wales, Victoria, Queensland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03374800?
The interventions under investigation include: Placebo (0.9% saline) (DRUG), Pantoprazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03374800?
This trial is sponsored by McMaster University, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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