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

McMaster University

Status

Enrolling

Conditions

COVID-19

GastroIntestinal Bleeding

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT05715567

COVID-19 REVISE_Cohort_22

Details and patient eligibility

About

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.

Full description

The overall aims are to further characterize the high-risk population of COVID-19 patients nested within the multicenter REVISE trial. Specifically, we plan 1) to explore the impact of PPIs on mechanically ventilated critically ill COVID-19 patients, 2) describe the clinical course for patients with COVID-19 and identify characteristics that predict poor prognosis, and 3) compare outcomes to patients without COVID-19. The overall research questions are as follows:

Do critically ill patients projected to receive mechanical ventilation for >48 hours with COVID-19 have different clinical outcomes without PPIs?
Are there prognostically relevant demographic, biomarker and clinical data to characterize critically ill patients with COVID-19?
Do critically ill patients with COVID-19 have significant higher rates of clinically important GI bleeding, 90-day mortality, and rates of infection when compared to a propensity-matched non-COVID REVISE cohort?

To accomplish this, the investigators propose to gather information in patients' medical charts including biomarkers drawn by the ICU team, venous thromboembolism (VTE) and tracheostomy timing, to link with extensive baseline characteristics and outcomes already collected in the REVISE trial (NCT03374800)

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Already received invasive mechanical ventilation >72 hours during this hospital admission
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]
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