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Lack of funding and other logistic reasons
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypothermia (32-33 degree C) | Experimental | Following randomization, hypothermia will be induced by a combination of cold isotonic fluid and sustained until organ procurement by a central venous catheter |
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| Normothermia (36.5 - 37.5 degree C) | No Intervention | Normothermia will be maintained until organ procurement as per current standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold isotonic fluid and central venous hypothermia catheter | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and safety | Brain-dead organ donors will be followed from study enrollment up to organ procurement for an average of 24 hours | From enrollment to organ procurement (average of 24 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Six-month hospital free survival in recipients | Data on recipient survival and allograft function will be collected up to 6 months following transplantation | 6 months |
| Interleukin-6 | Baseline, 6 hours, and at organ procurement (15-24 hrs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15261 | United States |
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| ID | Term |
|---|---|
| D001926 | Brain Death |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003128 | Coma |
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| Actual no. of organs transplanted | At the time of organ procurement |
| Malondialdehyde | Baseline, 6 hours, and at organ procurement (15-24 hrs) |
| Death receptor-5 | Baseline, 6 hours, and at organ procurement (15-24 hrs) |
| lactate | Baseline, 6 hours, and at organ procurement (15-24 hrs) |
| Urinary isoprostanes | Baseline, 6 hours, and at organ procurement (15-24 hrs) |
| D014474 |
| Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |