Feasibility of Mild-to-moderate Therapeutic Hypothermia as an In-vivo Organ Preservation Strategy in Brain-dead Donors
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- University of Pittsburgh
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Feasibility and safety
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Hypothermia (32-33 degree C)
Following randomization, hypothermia will be induced by a combination of cold isotonic fluid and sustained until organ procurement by a central venous catheter
Intervention: Cold isotonic fluid and central venous hypothermia catheter (Other)
Normothermia (36.5 - 37.5 degree C)
Normothermia will be maintained until organ procurement as per current standard of care
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Interleukin-6(Baseline, 6 hours, and at organ procurement (15-24 hrs))
- 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)
- 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))
Investigators
Raghavan Murugan
Associate Professor
University of Pittsburgh