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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
GroupInterventionDescription
Hypothermia (32-33 degree C)Cold isotonic fluid and central venous hypothermia catheterFollowing 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
NameTimeMethod
Feasibility and safetyFrom 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
NameTimeMethod
Actual no. of organs transplantedAt the time of organ procurement
Death receptor-5Baseline, 6 hours, and at organ procurement (15-24 hrs)
Six-month hospital free survival in recipients6 months

Data on recipient survival and allograft function will be collected up to 6 months following transplantation

Interleukin-6Baseline, 6 hours, and at organ procurement (15-24 hrs)
MalondialdehydeBaseline, 6 hours, and at organ procurement (15-24 hrs)
Urinary isoprostanesBaseline, 6 hours, and at organ procurement (15-24 hrs)
lactateBaseline, 6 hours, and at organ procurement (15-24 hrs)

Trial Locations

Locations (1)

University of Pittsburgh Medical Center

🇺🇸

Pittsburgh, Pennsylvania, United States

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