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Cooling to Optimize Organ Life in Donor Study (COOLDonor)

This study has been terminated.
(Lack of funding and other logistic reasons)
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01544530
First received: November 21, 2011
Last updated: May 5, 2014
Last verified: May 2014
  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 ]

Enrollment: 4
Study Start Date: March 2012
Study Completion Date: March 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544530

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
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: May 5, 2014
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
Coma
Consciousness Disorders
Death
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Unconsciousness

ClinicalTrials.gov processed this record on November 20, 2014