Recruiting

Observational Study

Sponsor:

McMaster University

Code:

NCT05715567

Conditions

COVID-19

GastroIntestinal Bleeding

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial (NCT03374800)

Study Details

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.

Conditions

COVID-19

GastroIntestinal Bleeding

Study ID

NCT05715567

Start date

Dec 1, 2021

Status verified date

Feb, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Oct 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Adults ≥18 years old projected to receive invasive mechanical ventilation for ≥48 hours according to the treating physician

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

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with COVID-19

Patients without COVID-19

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)

Primary outcome measure

  • Rate of clinically important gastro-intestinal bleeding [ Time Frame: 90 days ]
  • Primary Safety Outcome: 90 Day Mortality [ Time Frame: 90 days after randomization ]

Central Contacts and Locations

Central contacts

Deborah J Cook, MD

9055221155debcook@mcmaster.ca

Nicole Zytaruk, RN

9055221155zytaruk@mcmaster.ca

Locations

St Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Deborah Cook, MD

905-522-1155debcook@mcmaster.ca

Nicole Zytaruk, Reg. N

905-522-1155zytaruk@mcmaster.ca

Principal Investigator:

Deborah Cook, MD

More Information

Sponsor

McMaster University

Last update posted

Feb 8, 2023

Last verified

Feb, 2023

Keywords

  • COVID-19
  • pandemic
  • gastrointestinal bleeding
  • pneumonia
  • Clostridioides difficile

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2023-02-08.