Cooling to Optimize Organ Life in Donor Study

Phase 2TerminatedNCT01544530

University of Pittsburgh4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Organ Transplantation From Brain-dead Donors

Interventions

Cold isotonic fluid and central venous hypothermia catheterOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Feasibility and safety

Brain-dead organ donors will be followed from study enrollment up to organ procurement for an average of 24 hours

Time frame: From enrollment to organ procurement (average of 24 hours)

Secondary Outcomes

Six-month hospital free survival in recipients

Data on recipient survival and allograft function will be collected up to 6 months following transplantation

Time frame: 6 months

Interleukin-6