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) ]
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