Cooling to Optimize Organ Life in Donor Study (COOLDonor)
This study is currently recruiting participants.
Verified March 2012 by University of Pittsburgh
Sponsor:
University of Pittsburgh
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01544530
First received: November 21, 2011
Last updated: April 16, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Organ Transplantation From Brain-dead Donors |
Other: Cold isotonic fluid and central venous hypothermia catheter |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Feasibility of Mild-to-moderate Therapeutic Hypothermia as an In-vivo Organ Preservation Strategy in Brain-dead Donors |
Resource links provided by NLM:
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- Feasibility and safety [ Time Frame: From enrollment to organ procurement (average of 24 hours) ] [ Designated as safety issue: Yes ]Brain-dead organ donors will be followed from study enrollment up to organ procurement for an average of 24 hours
Secondary Outcome Measures:
- Six-month hospital free survival in recipients [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Data on recipient survival and allograft function will be collected up to 6 months following transplantation
- Interleukin-6 [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ] [ Designated as safety issue: Yes ]
- Actual no. of organs transplanted [ Time Frame: At the time of organ procurement ] [ Designated as safety issue: Yes ]
- Malondialdehyde [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ] [ Designated as safety issue: Yes ]
- Death receptor-5 [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ] [ Designated as safety issue: Yes ]
- lactate [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ] [ Designated as safety issue: Yes ]
- Urinary isoprostanes [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Other: 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
|
|
No Intervention: Normothermia (36.5 - 37.5 degree C)
Normothermia will be maintained until organ procurement as per current standard of care
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544530
Contacts
| Contact: Raghavan Murugan, MD, MS, FRCP | 412-647-1263 | muruganr@ccm.upmc.edu |
Locations
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| Principal Investigator: Raghavan Murugan, MD, MS, FRCP | |
Sponsors and Collaborators
University of Pittsburgh
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01544530 History of Changes |
| Other Study ID Numbers: | CORID - 335 |
| Study First Received: | November 21, 2011 |
| Last Updated: | April 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Brain-death organ donation |
Additional relevant MeSH terms:
|
Brain Death Brain Diseases Central Nervous System Diseases Nervous System Diseases Coma Unconsciousness |
Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Death Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013