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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05715567
Registration number
NCT05715567
Ethics application status
Date submitted
3/02/2023
Date registered
8/02/2023
Date last updated
8/02/2023
Titles & IDs
Public title
Re-EValuating the Inhibition of Stress Erosions (REVISE) - COVID-19 Cohort Study
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Scientific title
Re-EValuating the Inhibition of Stress Erosions (REVISE) - COVID-19 Cohort Study
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Secondary ID [1]
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COVID-19 REVISE_Cohort_22
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID-19
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GastroIntestinal Bleeding
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial (NCT03374800)
Patients with COVID-19 -
Patients without COVID-19 -
Other interventions: Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial (NCT03374800)
Following the intervention of the Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial (NCT03374800)
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of clinically important gastro-intestinal bleeding
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Assessment method [1]
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The primary efficacy outcome is clinically important GI bleeding occurring in the ICU or resulting in ICU readmission during the index hospital stay.
The definition of clinically important GI bleeding is overt GI bleeding (i.e., hematemesis, frank blood or coffee ground nasogastric aspirate, melena or hematochezia) plus 1 of the following in the absence of other causes:
Hemodynamic change defined as a spontaneous decrease in invasively monitored mean arterial pressure or non-invasive systolic or diastolic blood pressure of >20 mmHg, or an orthostatic increase in pulse rate of >20 beats/minute and a decrease in systolic blood pressure of >10 mmHg, with or without vasopressor initiation or increase;
vasopressor initiation;
hemoglobin decrease of >2 g/dl (20 g/L) within 24 h of bleeding;
transfusion of >2 units red blood cells within 24 h of bleeding; or
therapeutic intervention (e.g., therapeutic endoscopy, angiography, surgery).
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Timepoint [1]
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90 days
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Primary outcome [2]
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Primary Safety Outcome: 90 Day Mortality
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Assessment method [2]
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Mortality status at day 90 post randomization
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Timepoint [2]
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90 days after randomization
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Secondary outcome [1]
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Ventilator-associated pneumonia
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Assessment method [1]
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VAP is diagnosed in patients who received invasive mechanical ventilation for >48 hours when there is a new, progressive or persistent radiographic infiltrate plus at least 2 of the following without other obvious cause: 1) fever (temperature>38 °C) or hypothermia (temperature <36 °C); 2) leukopenia (<4.0x106/L) or leukocytosis (>12x106/L); 3) purulent sputum; or 4) gas exchange deterioration.
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Timepoint [1]
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90 Days (while in ICU,censored at 90 days after randomization)
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Secondary outcome [2]
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C. difficile infection
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Assessment method [2]
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Defined as clinical features (diarrhea [>3 episodes of unformed stools or Bristol type 6 or 7), ileus, or toxic megacolon) and either microbiological evidence of toxin-producing C. difficile or pseudomembranous colitis on colonoscopy in hospital.
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Timepoint [2]
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90 days (during the index hospital admission, censored at 90 days)
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Secondary outcome [3]
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Renal replacement therapy
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Assessment method [3]
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Defined as initiation of new renal replacement therapy in the ICU.
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Timepoint [3]
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While in ICU,censored at 90 days after randomization
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Secondary outcome [4]
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Hospital mortality
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Assessment method [4]
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Defined as all-cause mortality in hospital.
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Timepoint [4]
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While in hospital, censored at 90 days after randomization
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Secondary outcome [5]
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Patient important GI bleeding
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Assessment method [5]
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Defined as overt GI bleeding, plus an invasive intervention (e.g., therapeutic endoscopy, angiography, surgery), acknowledging how some clinically important GI bleeds in prior studies did not actually require any tests or treatments, and thus may not be important to patients. This outcome will be refined by an ongoing mixed methods study with an overarching instrument-building aim.
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Timepoint [5]
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Censored at 90 days after randomization
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Eligibility
Key inclusion criteria
Adults =18 years old projected to receive invasive mechanical ventilation for =48 hours
according to the treating physician
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Already received invasive mechanical ventilation >72 hours during this hospital
admission
2. Acid suppression for active gastrointestinal bleeding or high risk of bleeding (e.g.,
current bleeding, peptic ulcer bleeding within 8 weeks, recent severe esophagitis,
Barrett's esophagus, Zollinger-Ellison syndrome); [dyspepsia or gastroesophageal
reflux is not an exclusion criterion]
3. Acid suppression in the intensive care unit for >1 daily dose equivalent of a proton
pump inhibitor or histamine-2-receptor antagonist
4. Dual antiplatelet therapy
5. Combined antiplatelet and therapeutic anticoagulation
6. Pantoprazole contraindication per local product information
7. Palliative care or anticipated withdrawal of advanced life support
8. Pregnancy
9. Previous enrolment in REVISE, or a related trial, or trial for which co-enrolment is
prohibited
10. Patient, proxy or physician declines
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Funding & Sponsors
Primary sponsor type
Other
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Name
McMaster University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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The Physicians' Services Incorporated Foundation
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Commonly employed medications used in critically ill patients requiring life support include
proton pump inhibitors (PPIs). These medications are thought to prevent gastrointestinal (GI)
bleeding from stress-induced ulceration. Despite their widespread use, they do hold some
risks which include infection in the form of pneumonia and diarrheal illnesses such as
Clostridioides difficile infection (C. difficile). Emerging high-quality studies suggest PPI
usage does not influence susceptibility to COVID-19 infection, however some studies suggest
PPI use leads to poor outcomes in this population, including prolonged time on life-support
and death. While we can appreciate the negative effects of PPI may be magnified in the
sickest of patients, namely hospitalized patients with COVID-19, the beneficial or
potentially harmful role they play in this population remains unclear.
We aim to build a clinical profile to further describe critically ill patients with COVID-19
in Ontario using the infrastructure of an ongoing multicenter clinical trial of acid
suppression. We will identify characteristics that predict poor outcomes among sick COVID
patients, examining the impact of PPIs on this population.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05715567
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Deborah Cook, MD
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Address
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McMaster University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Deborah J Cook, MD
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Address
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Country
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Phone
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9055221155
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05715567
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