Stress Ulcer Prophylaxis Prescribing Options for Critically Ill Patients in Hospitals Participating in a Randomized Controlled Trial: A Protocol and Statistical Analysis Plan

Abstract Background Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) predominate as stress ulcer prophylaxis (SUP) agents in intensive care units (ICUs). Prescribing patterns may change over time as randomized controlled trials evaluate SUP in critically ill patients. Objective This study aims to compare site-specific, self-reported SUP prescribing practices before and after the REVISE trial in participating ICUs. Methods This is a pre-planned study as part of the REVISE trial ( NCT03374800 ), which compared intravenous pantoprazole with placebo in mechanically ventilated patients. The REVISE trial showed that intravenous pantoprazole reduced the risk of clinically important upper gastrointestinal bleeding (GIB) and patient-important upper GIB, without a significant effect on mortality or other clinical outcomes. We conducted a survey of all research teams (paired research coordinators and site physicians) in 68 participating trial centers, both before they enrolled patients and after the completion of the trial to record their self-reported SUP practice patterns. Results We will report ICU-level data on the typical SUP agent prescribed, the presence and content of preprinted orders or electronic admission order sets, and SUP discontinuation practices. We will apply descriptive statistics to summarize these patterns and compare them between the pre- and post-trial phases. Conclusions This study will describe contemporary data on SUP prescribing and discontinuation patterns before and after an international randomized controlled trial in participating trial centers.