title: End points for phase II trials in intensive care: recommendations from the Australian and New Zealand Clinical Trials Group consensus panel meeting.
abstract: 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.
  
  
  METHODS
  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.
  
  
  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.
authors.affiliation: Wellington Regional Hospital, Capital and Coast District Health Board, Wellington, New Zealand.
authors.forename: Paul
authors.initials: P
authors.lastname: Young
authors.forename: Carol
authors.initials: C
authors.lastname: Hodgson
authors.forename: Joel
authors.initials: J
authors.lastname: Dulhunty
authors.forename: Manoj
authors.initials: M
authors.lastname: Saxena
authors.forename: Michael
authors.initials: M
authors.lastname: Bailey
authors.forename: Rinaldo
authors.initials: R
authors.lastname: Bellomo
authors.forename: Andrew
authors.initials: A
authors.lastname: Davies
authors.forename: Simon
authors.initials: S
authors.lastname: Finfer
authors.forename: Peter
authors.initials: P
authors.lastname: Kruger
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Lipman
authors.forename: John
authors.initials: J
authors.lastname: Myburgh
authors.forename: Sandra
authors.initials: S
authors.lastname: Peake
authors.forename: Ian
authors.initials: I
authors.lastname: Seppelt
authors.forename: Stephen
authors.initials: S
authors.lastname: Streat
authors.forename: Rhiannon
authors.initials: R
authors.lastname: Tate
authors.forename: Steven
authors.initials: S
authors.lastname: Webb
mesh_terms: D001315:Australia; D017322:Clinical Trials, Phase II as Topic; D016638:Critical Illness / Q000401:mortality*; D023381:Endpoint Determination; D006801:Humans; D009520:New Zealand; D017063:Outcome Assessment, Health Care; D018401:Sample Size