A randomized clinical trial

Aim

To conduct a randomized clinical trial to assess the benefits and harms of treatment with SUP in adult critically ill patients in the ICU.  

 

Hypothesis

SUP is not different from placebo.  

 

Design

A randomized double-blind placebo-controlled trial.

 

Setting

General ICUs in Europe, Australia, New Zealand, Canada and US.  

 

Population

Mechanically ventilated adult critically ill patients in the ICU.

 

Intervention

SUP with proton pump inhibitor.

 

Comparator

Placebo.

 

Outcome measures

Primary: 90-day mortality; secondary: GI bleeding, pneumonia, Clostridium difficile infection, and use of blood products.

 

Data

Demographic, clinical, and prognostic variables.

 

Statistics

Intention-to-treat (ITT) analysis, and sensitivity analyses. Crude and adjusted RRs with 95% CIs. Interrim analysis.

 

Sample size

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.

 

Time frame

2015-2016.