A 7-day inception cohort study

Aim

To describe the incidence and severity of GI bleeding in adult critically ill patients in the ICU, and to describe current practice of SUP.

 

Hypothesis

The incidence of GI bleeding is low, and current practice of SUP in the ICU is based on locale preferences (low/very low level of evidence). 

 

Design

A 7-day inception cohort study.

 

Setting

ICUs in Scandinavia, United Kingdom, Italy, The Netherlands, Spain, Australia and New Zealand (50 sites).  

 

Population

Adult critically ill patients in the ICU.

 

Data

Demographic, clinical, and prognostic variables.

 

Outcome measures

90-day mortality and GI bleeding.

 

Statistics

Proportions and percent. Crude and adjusted relative risks (RRs) with 95% confidence intervals (CIs). Statistical Analysis Plan

 

Sample size

With an estimated incidence of GI bleeding in the ICU of 2-4%, α=0.05, and β=0.2, inclusion of 1.000 patients is needed.

 

Registration and approval

The manuscript will be prepared according to the STROBE statement, and reported to the National Data Protection Agencies.

 

Status

Enrolment of sites.