Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation
Deborah Cook, Adam M. Deane, François Lauzier, Nicole Zytaruk, Gordon Guyatt, Lois Saunders, M.J. Hardie, Diane Heels‐Ansdell, Waleed Alhazzani, John C. Marshall, John Muscedere, John Myburgh, Shane English, Yaseen M. Arabi, Marlies Ostermann, Serena Knowles, Naomi Hammond, Kathleen Byrne, Marianne J. Chapman, Balasubramanian Venkatesh, Paul J. Young, Dorrilyn Rajbhandari, Alexis Poole, Abdulrahman Al‐Fares, Gilmar Reis, Daniel Johnson, Mobeen Iqbal, Richard Hall, Maureen O. Meade, Lori Hand, Erick Duan, France Clarke, Joanna C. Dionne, Jennifer Tsang, Bram Rochwerg, Timothy Karachi, François Lamontagne, Frédérick D’Aragon, Charles St. Arnaud, Brenda Reeve, Anna Geagea, Daniel J. Niven, Gloria Vázquez‐Grande, Ryan Zarychanski, Daniel Ovakim, Gordon Wood, Karen E. A. Burns, Alberto Goffi, M. Elizabeth Wilcox, William R. Henderson, David M. Forrest, Rob Fowler, Neill K. J. Adhikari, Ian Ball, Tina Mele, Alexandra Binnie, Sébastien Trop, Sangeeta Mehta, Ingrid Morgan, Osama Loubani, Meredith Vanstone, Kirsten M. Fiest, Emmanuel Charbonney, Yiorgos Alexandros Cavayas, Patrick Archambault, Oleksa Rewa, Vincent Lau, Arnold S. Kristof, Kosar Khwaja, David Williamson, Salmaan Kanji, Eric Sy, Brittany B. Dennis, Steve Reynolds, François Marquis, François Lellouche, Adam Rahman, Paul Hosek, Jeffrey F. Barletta, Robert Cirrone, Mark Tutschka, Feng Xie, Laurent Billot, Lehana Thabane, Simon Finfer
Abstract
BACKGROUND: Whether proton-pump inhibitors are beneficial or harmful for stress ulcer prophylaxis in critically ill patients undergoing invasive ventilation is unclear. METHODS: infection, and patient-important bleeding. RESULTS: A total of 4821 patients underwent randomization in 68 ICUs. Clinically important upper gastrointestinal bleeding occurred in 25 of 2385 patients (1.0%) receiving pantoprazole and in 84 of 2377 patients (3.5%) receiving placebo (hazard ratio, 0.30; 95% confidence interval [CI], 0.19 to 0.47; P<0.001). At 90 days, death was reported in 696 of 2390 patients (29.1%) in the pantoprazole group and in 734 of 2379 patients (30.9%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.85 to 1.04; P = 0.25). Patient-important bleeding was reduced with pantoprazole; all other secondary outcomes were similar in the two groups. CONCLUSIONS: Among patients undergoing invasive ventilation, pantoprazole resulted in a significantly lower risk of clinically important upper gastrointestinal bleeding than placebo, with no significant effect on mortality. (Funded by the Canadian Institutes of Health Research and others; REVISE ClinicalTrials.gov number, NCT03374800.).