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

November 21, 2011
May 5, 2014
March 2012
March 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01544530 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cooling to Optimize Organ Life in Donor Study
Feasibility of Mild-to-moderate Therapeutic Hypothermia as an In-vivo Organ Preservation Strategy in Brain-dead Donors

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Organ Transplantation From Brain-dead Donors
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
  • 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
    Intervention: Other: Cold isotonic fluid and central venous hypothermia catheter
  • No Intervention: Normothermia (36.5 - 37.5 degree C)
    Normothermia will be maintained until organ procurement as per current standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01544530
CORID - 335
Yes
University of Pittsburgh
University of Pittsburgh
Not Provided
Not Provided
University of Pittsburgh
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP