ANZCTR - Registration

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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]

COVID-19 REVISE_Cohort_22

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Condition category

Condition code

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

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?

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)

Funding & Sponsors

Primary sponsor type

Other

Name

McMaster University

Address

Country

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/study/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

Deborah Cook, MD

Address

McMaster University

Country

Phone

Fax

Contact person for public queries

Name

Deborah J Cook, MD

Address

Country

Phone

9055221155

Fax

debcook@mcmaster.ca

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05715567

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05715567