Cooling to Optimize Organ Life in Donor Study
Phase 2
Terminated
- Conditions
- Organ Transplantation From Brain-dead Donors
- Interventions
- Other: Cold isotonic fluid and central venous hypothermia catheter
- Registration Number
- NCT01544530
- Lead Sponsor
- University of Pittsburgh
- 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 Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
- Age greater than 18 years;pronounced dead as per hospital brain-death criteria
- Accepted by organ procurement organization for organ donation
- Subjects within 3 hours of brain death pronouncement
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Exclusion Criteria
- Consent cannot be obtained from authorized representative;mean arterial pressure < 60 mmHg and/ or more than 2 vasopressor and/or inotrope use
- Presence of 2nd or 3rd degree heart block
- Ongoing extracranial hemorrhage
- International normalized ratio > 3.0
- Donors with human-immunodeficiency virus infection
- Pregnancy
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypothermia (32-33 degree C) Cold isotonic fluid and central venous hypothermia catheter Following randomization, hypothermia will be induced by a combination of cold isotonic fluid and sustained until organ procurement by a central venous catheter
- Primary Outcome Measures
Name Time Method Feasibility and safety 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
- Secondary Outcome Measures
Name Time Method Actual no. of organs transplanted At the time of organ procurement Death receptor-5 Baseline, 6 hours, and at organ procurement (15-24 hrs) Six-month hospital free survival in recipients 6 months Data on recipient survival and allograft function will be collected up to 6 months following transplantation
Interleukin-6 Baseline, 6 hours, and at organ procurement (15-24 hrs) Malondialdehyde Baseline, 6 hours, and at organ procurement (15-24 hrs) Urinary isoprostanes Baseline, 6 hours, and at organ procurement (15-24 hrs) lactate Baseline, 6 hours, and at organ procurement (15-24 hrs)
Trial Locations
- Locations (1)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States