Trial Review

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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
Scientific title
Re-EValuating the Inhibition of Stress Erosions (REVISE) - COVID-19 Cohort Study
Secondary ID [1] 0 0
COVID-19 REVISE_Cohort_22
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
GastroIntestinal Bleeding 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of clinically important gastro-intestinal bleeding
Timepoint [1] 0 0
90 days
Primary outcome [2] 0 0
Primary Safety Outcome: 90 Day Mortality
Timepoint [2] 0 0
90 days after randomization
Secondary outcome [1] 0 0
Ventilator-associated pneumonia
Timepoint [1] 0 0
90 Days (while in ICU,censored at 90 days after randomization)
Secondary outcome [2] 0 0
C. difficile infection
Timepoint [2] 0 0
90 days (during the index hospital admission, censored at 90 days)
Secondary outcome [3] 0 0
Renal replacement therapy
Timepoint [3] 0 0
While in ICU,censored at 90 days after randomization
Secondary outcome [4] 0 0
Hospital mortality
Timepoint [4] 0 0
While in hospital, censored at 90 days after randomization
Secondary outcome [5] 0 0
Patient important GI bleeding
Timepoint [5] 0 0
Censored at 90 days after randomization

Eligibility
Key inclusion criteria
Adults =18 years old projected to receive invasive mechanical ventilation for =48 hours
according to the treating physician
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Physicians' Services Incorporated Foundation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05715567
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Deborah Cook, MD
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Deborah J Cook, MD
Address 0 0
Country 0 0
Phone 0 0
9055221155
Fax 0 0
Email 0 0
debcook@mcmaster.ca
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05715567