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Recruiting
NCT05715567
Re-EValuating the Inhibition of Stress Erosions (REVISE) - COVID-19 Cohort Study
Conditions: COVID-19, GastroIntestinal Bleeding
Sex: All
Ages: 18 Years – N/A
Enrollment: 600
Sponsor: McMaster University
Location: Canada
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.
Eligibility Criteria
Inclusion Criteria:Adults ≥18 years old projected to receive invasive mechanical ventilation for ≥48 hours according to the treating physicianExclusion Criteria:Already received invasive mechanical ventilation >72 hours during this hospital admissionAcid 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 antagonistDual antiplatelet therapyCombined antiplatelet and therapeutic anticoagulationPantoprazole contraindication per local product informationPalliative care or anticipated withdrawal of advanced life supportPregnancyPrevious enrolment in REVISE, or a related trial, or trial for which co-enrolment is prohibitedPatient, proxy or physician declines
Source: ClinicalTrials.gov (NCT05715567). StuddyBuddy aggregates publicly available trial information.