Cooling to Optimize Organ Life in Donor Study (COOLDonor)

University of Pittsburgh

Status and phase: Terminated; Phase 2

Conditions: Organ Transplantation From Brain-dead Donors

Treatments: Other: Cold isotonic fluid and central venous hypothermia catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01544530

CORID - 335

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Hypothermia (32-33 degree C)

Experimental group

Description:

Following randomization, hypothermia will be induced by a combination of cold isotonic fluid and sustained until organ procurement by a central venous catheter

Treatment:

Other: Cold isotonic fluid and central venous hypothermia catheter

Normothermia (36.5 - 37.5 degree C)

No Intervention group

Description:

Normothermia will be maintained until organ procurement as per current standard of care