Re-EValuating the Inhibition of Stress Erosions (REVISE) - COVID-19 Cohort Study

NCT05715567 | Unknown DMC

• 1 other identifier: COVID-19 REVISE_Cohort_22
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Rate of clinically important gastro-intestinal bleeding

  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: 1. 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; 2. vasopressor initiation; 3. hemoglobin decrease of \>2 g/dl (20 g/L) within 24 h of bleeding; 4. transfusion of \>2 units red blood cells within 24 h of bleeding; or 5. therapeutic intervention (e.g., therapeutic endoscopy, angiography, surgery).

  90 days

• Primary Safety Outcome: 90 Day Mortality

  Mortality status at day 90 post randomization

  90 days after randomization

Secondary Outcomes (5)

• Ventilator-associated pneumonia

  90 Days (while in ICU,censored at 90 days after randomization)

• C. difficile infection

  90 days (during the index hospital admission, censored at 90 days)

• Renal replacement therapy

  While in ICU,censored at 90 days after randomization

• Hospital mortality

  While in hospital, censored at 90 days after randomization

• Patient important GI bleeding

  Censored at 90 days after randomization

Study Arms (2)

Patients with COVID-19

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

Patients without COVID-19

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

Interventions

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

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

Patients with COVID-19; Patients without COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are eligible according to the inclusion and exclusion criteria of the REVISE trial, regardless of COVID status

You may qualify if:

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

You may not qualify if:

• Already received invasive mechanical ventilation \>72 hours during this hospital admission
• Acid suppression in the intensive care unit for \>1 daily dose equivalent of a proton pump inhibitor or histamine-2-receptor antagonist
• Dual antiplatelet therapy
• Combined antiplatelet and therapeutic anticoagulation
• Pantoprazole contraindication per local product information
• Palliative care or anticipated withdrawal of advanced life support
• Pregnancy
• Previous enrolment in REVISE, or a related trial, or trial for which co-enrolment is prohibited
• Patient, proxy or physician declines

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Related Publications (1)

• Dennis BB, Thabane L, Heels-Ansdell D, Dionne JC, Binnie A, Tsang J, Guyatt G, Ahmed A, Lauzier F, Deane A, Arabi Y, Marshall J, Zytaruk N, Saunders L, Finfer S, Myburgh J, Muscedere J, English S, Ostermann M, Hardie M, Knowles S, Cook D; REVISE Investigators the Canadian Critical Care Trials Group. Proton pump inhibitors in critically ill mechanically ventilated patients with COVID-19: protocol for a substudy of the Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial. Trials. 2023 Aug 30;24(1):561. doi: 10.1186/s13063-023-07589-2.

  PMID: 37644556 DERIVED

MeSH Terms

Conditions

COVID-19; Gastrointestinal Hemorrhage; Pneumonia

Interventions

Reoperation; Clinical Trials as Topic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Deborah Cook, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Brittany Dennis, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah J Cook, MD

CONTACT

9055221155; debcook@mcmaster.ca

Nicole Zytaruk, RN

CONTACT

9055221155; zytaruk@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 8, 2023
• Study Start: December 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)