Clinical Trial: Cooling to Optimize Organ Life in Donor Study

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Feasibility of Mild-to-moderate Therapeutic Hypothermia as an In-vivo Organ Preservation Strategy in Brain-dead Donors

Brief Summary: The purpose of this study is to assess the feasibility and safety of mild-to-moderate hypothermia as an in-vivo organ preservation strategy compared to normothermia in 60 brain-dead organ donors.

Detailed Summary:
Sponsor: University of Pittsburgh

Current Primary Outcome: Feasibility and safety [ Time Frame: From enrollment to organ procurement (average of 24 hours) ]

Brain-dead organ donors will be followed from study enrollment up to organ procurement for an average of 24 hours


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Six-month hospital free survival in recipients [ Time Frame: 6 months ]
    Data on recipient survival and allograft function will be collected up to 6 months following transplantation
  • Interleukin-6 [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ]
  • Actual no. of organs transplanted [ Time Frame: At the time of organ procurement ]
  • Malondialdehyde [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ]
  • Death receptor-5 [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ]
  • lactate [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ]
  • Urinary isoprostanes [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ]


Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: November 21, 2011
Date Started: March 2012
Date Completion:
Last Updated: May 5, 2014
Last Verified: May 2014