TY - JOUR
AU - 
AU - Hodgson C.
AU - Davies A.
AU - Kruger P.
AU - Lipman J.
AU - Streat S.
AU - Webb S.
AU - Finfer Simon
AU - Dulhunty J.
AU - Bellomo Rinaldo
AU - Young P.
AU - Peake S.
AU - Tate R.
AU - Bailey M.
AU - Seppelt I.
AU - M. Saxena
AB - <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.
</p>

AD - Wellington Regional Hospital, Capital and Coast District Health Board, Wellington, New Zealand.
AN - 22963216
BT - Critical Care and Resuscitation
DA - 241880093202
DP - NLM
ET - 2012/09/12
LA - eng
M1 - 3
N1 - Young, PaulHodgson, CarolDulhunty, JoelSaxena, ManojBailey, MichaelBellomo, RinaldoDavies, AndrewFinfer, SimonKruger, PeterLipman, JeffreyMyburgh, JohnPeake, SandraSeppelt, IanStreat, StephenTate, RhiannonWebb, StevenANZICS Clinical Trials GroupAustraliaCrit Care Resusc. 2012 Sep;14(3):211-5.
N2 - <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.
</p>

PY - 2012
SN - 1441-2772 (Print)1441-2772 (Linking)
SP - 211
EP - 5
T2 - Critical Care and Resuscitation
TI - End points for phase II trials in intensive care: recommendations from the Australian and New Zealand Clinical Trials Group consensus panel meeting
VL - 14
ER -