To conduct a randomized clinical trial to assess the benefits and harms of treatment with SUP in adult critically ill patients in the ICU.
SUP is not different from placebo.
A randomized double-blind placebo-controlled trial.
General ICUs in Europe, Australia, New Zealand, Canada and US.
Mechanically ventilated adult critically ill patients in the ICU.
SUP with proton pump inhibitor.
Primary: 90-day mortality; secondary: GI bleeding, pneumonia, Clostridium difficile infection, and use of blood products.
Demographic, clinical, and prognostic variables.
Intention-to-treat (ITT) analysis, and sensitivity analyses. Crude and adjusted RRs with 95% CIs. Interrim analysis.
3000 patients (2 x 1500) are needed to show a 15% relative risk reduction (5% absolute risk reduction) in the primary outcome measure, assuming a baseline 90-day mortality rate of 35%, α=0.05 (two-sided), and β=0.2.
Registration and approval
Approval by The National Data Protection Agencies, Medicines Agencies, and Ethics Committees. Registration at ClinicalTrials.gov. External monitoring by the national GCP units. Independent data monitoring by a and safety committee. The manuscript will be prepared according to the CONSORT statement.