Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2012-03-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Cold 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
Normothermia (36.5 - 37.5 degree C)
Normothermia will be maintained until organ procurement as per current standard of care
No interventions assigned to this group
Interventions
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Cold 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
Eligibility Criteria
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Inclusion Criteria
* Accepted by organ procurement organization for organ donation
* Subjects within 3 hours of brain death pronouncement
Exclusion Criteria
* Presence of 2nd or 3rd degree heart block
* Ongoing extracranial hemorrhage
* International normalized ratio \> 3.0
* Donors with human-immunodeficiency virus infection
* Pregnancy
18 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Raghavan Murugan
Associate Professor
Locations
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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CORID - 335
Identifier Type: -
Identifier Source: org_study_id
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