Effects of proton pump inhibitors for stress ulcer prophylaxis in critically ill patients: A randomized control trial

Background: Critically ill patients are prone to gastrointestinal bleeding, leading to hemodynamic instability, transfusions, and prolonged hospitalization. Stress ulcer prophylaxis with proton pump inhibitors is commonly used in intensive care, but their benefit is uncertain and may increase hospital-acquired pneumonia risk. This study aimed to evaluate the efficacy and safety of proton pump inhibitors (PPIs) for stress ulcer prophylaxis, focusing on the occurrence of gastrointestinal bleeding and pneumonia. Method: An open label, randomized controlled trial was conducted at Chiangrai Prachanukroh Hospital between January and October 2022. Critically ill patients were randomly assigned to receive a once-daily dose of omeprazole 40 mg intravenously or without prophylaxis; all received enteral nutrition. The primary outcome was the rate of gastrointestinal bleeding at 30 days, and hospital-acquired pneumonia was a safety outcome. Results: One hundred thirty patients were enrolled (65 per group). Baseline characteristics, disease severity, laboratory values, and feeding parameters were comparable between groups. The duration of mechanical ventilation was longer in the PPI group, and all patients received enteral nutrition with similar feeding profiles. Gastrointestinal bleeding occurred in 6.15% of patients in the proton pump inhibitor group and 3.08% of controls, with no statistically significant difference. Hospital-acquired pneumonia occurred more frequently in the PPI group than in the control group (23.08% vs. 9.23%) in the crude analysis; however, PPI use was not independently associated with hospital-acquired pneumonia after multivariate adjustment. Mortality was higher in the PPI group (9.23% vs. 1.54%), but the difference was not statistically significant. Conclusions: Critically ill patients on PPIs have comparable rates of gastrointestinal bleeding. Although the incidence of hospital-acquired pneumonia is higher in the PPI group, the multivariable analysis shows no statistically significant difference. Trial registration: TCTR20260116007