Organ Transplantation From Brain-dead Donors
Conditions
Keywords
Brain-death, organ donation
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.
Interventions
OTHERCold isotonic fluid and central venous hypothermia catheter
20-30ml/kg of isotonic crystalloid resuscitation fluid will be used for induction. Hypothermia (32-33 degrees C) will be sustained until organ procurement using an FDA approved central venous catheter connected to an external temperature regulating system
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| lactate | Baseline, 6 hours, and at organ procurement (15-24 hrs) | — |
| Death receptor-5 | Baseline, 6 hours, and at organ procurement (15-24 hrs) | — |
| Urinary isoprostanes | Baseline, 6 hours, and at organ procurement (15-24 hrs) | — |
| Actual no. of organs transplanted | At the time of organ procurement | — |
Countries
United States
Outcome results
None listed