Status:
COMPLETED
Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Canadian Critical Care Trials Group
Conditions:
Gastrointestinal Hemorrhage (Clinically Important, Upper)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 pat...
Detailed Description
Background: For 40 years, pharmacologic prevention of stress ulcer-related gastrointestinal (GI) bleeding with acid suppression has been the standard of care for invasively mechanically ventilated ICU...
Eligibility Criteria
Inclusion
- 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
- 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
- being treated with high dose methotrexate (i.e., greater than 300 mg as part of a chemotherapy regimen).
- documented cirrhosis or severe liver disease (for example as indicated by an INR greater than 5.0 due to underlying liver disease).
- Canada;
- being treated with rilpivirine or atazanavir
- patients who are hypersensitive to pantoprazole, substituted benzimidazoles, or to any ingredient in the formulation
- Patients in whom a PPI or histamine 2 receptor antagonist (H2RA) is indicated due to active bleeding or increased bleeding risk, defined as patients with acute GI bleeding, severe oesophagitis or peptic ulcer disease within the previous 8 weeks, Zollinger Ellison syndrome, Barrett's oesophagus or any previous admission to hospital because of upper GI bleeding (patients receiving PPIs for mild dyspepsia or mild gastroesophageal reflux disease or an uncertain indication are not excluded).
- Received invasive mechanical ventilation during this ICU admission for 72 hours or more.
- Patients who have received more than 24 hours treatment (i.e., more than one daily dose equivalent) with a PPI or H2RA during this ICU admission.
- Being treated with or need for dual anti-platelet therapy.
- Admitted for palliative care or the ICU physician is not committed to continuing life-sustaining therapies at the time of enrolment.
- Known or suspected pregnancy.
- Physician, patient, or substitute decision maker (SDM) declines.
- Previously enrolled in the REVISE trial
- Enrolled in another trial for which co-enrolment is not approved.
Key Trial Info
Start Date :
July 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
4800 Patients enrolled
Trial Details
Trial ID
NCT03374800
Start Date
July 9 2018
End Date
January 31 2024
Last Update
September 20 2024
Active Locations (67)
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1
University of Nebraska - Nebraska Medical Center
Omaha, Nebraska, United States, 987400
2
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia, 2200
3
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
4
Sutherland Hospital
Caringbah, New South Wales, Australia, 2050