Background: There is uncertainty about which end points should be used for Phase II trials in critically ill patients.
Objective: To systematically evaluate potential end points for Phase II trials in critically ill patients.
Design and setting: A report outlining a process of literature review and recommendations from a consensus meeting conducted on behalf of the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) in October 2011.
Results and conclusions: The consensus panel concluded that there are no adequately validated end points for Phase II trials in critically ill patients. However, the following were identified as potential Phase II end points: hospital-free days to Day 90, ICU-free days to Day 28, ventilator-free days to Day 28, cardiovascular support-free days to Day 28, and renal replacement therapy-free days to Day 28. We recommend that these end points be evaluated further.