01784nas a2200325   4500000000100000008004100001260001700042100000500059700001500064700001400079700001400093700001400107700001400121700001200135700001700147700001600164700002000180700001300200700001300213700001200226700001400238700001500252700001400267245015200281250001500433300001000448490000700458520095200465020004101417       2012                            d  c2418800932021 a1 aHodgson C.1 aDavies A.1 aKruger P.1 aLipman J.1 aStreat S.1 aWebb S.1 aFinfer Simon1 aDulhunty J.1 aBellomo Rinaldo1 aYoung P.1 aPeake S.1 aTate R.1 aBailey M.1 aSeppelt I.1 aM. Saxena00aEnd points for phase II trials in intensive care: recommendations from the Australian and New Zealand Clinical Trials Group consensus panel meeting  a2012/09/12  a211-50 v143 a<p>
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.
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