6/29/23, 11:57 PM SUP-ICU Pathway Feedback Search Clinical Topics Home Studies SUP ICU SUP ICU Disease Disease Disease Lower gastrointestinal bleeding Non-variceal upper gastrointesti Variceal h Trial question What is the role of pantoprazole in patients at risk for gastrointestinal bleeding in the ICU? Study design Multi-center Double blinded RCT Population Characteristics of study participants 36.0% female N = 3298 64.0% male 3298 patients (1185 female, 2106 male) Inclusion criteria: adults admitted to the ICU for an acute condition who were at risk for gastrointestinal bleeding Key exclusion criteria: ongoing daily treatment with acid suppressants, gastrointestinal bleeding during index hospital admission, withdrawn from active therapy or brain dead, organ transplantation during index hospital admission, peptic ulcer, contraindication to pantoprazole, pregnant Interventions N=1645 pantoprazole (intravenous injection of 40 mg suspended in 10 ml of 0.9% sodium chloride daily for a maximum of 90 days) https://web.pathway.md/studies/recfwufeSkj58BX5P 1/2 6/29/23, 11:57 PM SUP-ICU Pathway N=1653 placebo (intravenous injection of matching placebo suspended in 10 ml of 0.9% sodium chloride daily for a maximum of 90 days) Primary outcome Death at 90 days 31.1 % 31.1 30.4 23.3 % 15.6 % 7.8 % No significant difference 0.0 % Pantoprazole Placebo No significant difference in death at 90 days (31.1% vs. 30.4%; RR 1.02, 95% CI 0.91 to 1.13) Secondary outcomes No significant difference in clinically important gastrointestinal bleeding, pneumonia, C. difficile infection, or myocardial ischemia, during the ICU stay (21.9% vs. 22.6%; RR 0.96, 96% CI 0.83 to 1.11) Safety outcomes No significant differences in serious adverse reactions, number of patients with infections and the percentage of days alive without life support within 90 days. Conclusion In adults admitted to the ICU for an acute condition who were at risk for gastrointestinal bleeding, pantoprazole was not superior to placebo with respect to death at 90 days. Reference Krag M, Marker S, Perner A et al. Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU. N Engl J Med. 2018 Dec 6;379(23):2199-2208. Open reference URL https://web.pathway.md/studies/recfwufeSkj58BX5P 2/2