Brittany B Dennis, Lehana Thabane, Diane Heels-Ansdell, Joanna C Dionne, Alexandra Binnie, Jennifer Tsang, Gordon Guyatt, Aijaz Ahmed, François Lauzier, Adam Deane, Yaseen Arabi, John Marshall, Nicole Zytaruk, Lois Saunders, Simon Finfer, John Myburgh, John Muscedere, Shane English, Marlies Ostermann, Miranda Hardie, Serena Knowles, Deborah Cook
BACKGROUND: Critically ill patients commonly receive proton pump inhibitors (PPIs) to prevent gastrointestinal (GI) bleeding from stress-induced ulceration. Despite widespread use in the intensive care unit (ICU), observational data suggest that PPIs may be associated with adverse outcomes in patients with COVID-19 infection. This preplanned study is nested within a large randomized trial evaluating pantoprazole versus placebo in invasively ventilated patients. The 3 objectives are as follows: (1) to describe the characteristics of patients with COVID-19 in terms of demographics, biomarkers, venous thromboembolism, tracheostomy incidence and timing, and other clinical outcomes; (2) to evaluate the impact of COVID-19 infection on clinically important GI bleeding, 90-day mortality, and other outcomes compared to a propensity-matched non-infected cohort; and (3) to explore whether pantoprazole has a differential treatment effect on clinically important GI bleeding, 90-day mortality, and other outcomes in patients with and without COVID-19 infection...
August 30, 2023: Trials