• Crit Care Resusc · Sep 2012

    End points for phase II trials in intensive care: recommendations from the Australian and New Zealand Clinical Trials Group consensus panel meeting.

    • Paul Young, Carol Hodgson, Joel Dulhunty, Manoj Saxena, Michael Bailey, Rinaldo Bellomo, Andrew Davies, Simon Finfer, Peter Kruger, Jeffrey Lipman, John Myburgh, Sandra Peake, Ian Seppelt, Stephen Streat, Rhiannon Tate, Steven Webb, and ANZICS Clinical Trials Group.
    • Wellington Regional Hospital, Capital and Coast District Health Board, Wellington, New Zealand.
    • Crit Care Resusc. 2012 Sep 1;14(3):211-5.

    BackgroundThere is uncertainty about which end points should be used for Phase II trials in critically ill patients.ObjectiveTo systematically evaluate potential end points for Phase II trials in critically ill patients.Design And SettingA 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 ConclusionsThe 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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