Cooling to Optimize Organ Life in Donor Study (COOLDonor)

This study is currently recruiting participants.

Verified March 2012 by University of Pittsburgh

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 21, 2011

Last Updated Date

April 16, 2012

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01544530 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cooling to Optimize Organ Life in Donor Study

Official Title ^ICMJE

Feasibility of Mild-to-moderate Therapeutic Hypothermia as an In-vivo Organ Preservation Strategy in Brain-dead Donors

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Organ Transplantation From Brain-dead Donors

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2014

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Raghavan Murugan, MD, MS, FRCP

412-647-1263

muruganr@ccm.upmc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01544530

Other Study ID Numbers ^ICMJE

CORID - 335

Has Data Monitoring Committee

Yes

Responsible Party

University of Pittsburgh

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

University of Pittsburgh

Verification Date

March 2012

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

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