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.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study did not receive any funding.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present work are contained in the manuscript.

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