Cooling to Optimize Organ Life in Donor Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Organ Transplantation From Brain-dead Donors

Intervention / Treatment
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* Other: Cold isotonic fluid and central venous hypothermia catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypothermia (32-33 degree C)<br>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<br>* 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<br>|
| No Intervention: Normothermia (36.5 - 37.5 degree C)<br>Normothermia will be maintained until organ procurement as per current standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and safety | Brain-dead organ donors will be followed from study enrollment up to organ procurement for an average of 24 hours | From enrollment to organ procurement (average of 24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-month hospital free survival in recipients | Data on recipient survival and allograft function will be collected up to 6 months following transplantation | 6 months | 
| Interleukin-6 |  | Baseline, 6 hours, and at organ procurement (15-24 hrs) | 
| Actual no. of organs transplanted |  | At the time of organ procurement | 
| Malondialdehyde |  | Baseline, 6 hours, and at organ procurement (15-24 hrs) | 
| Death receptor-5 |  | Baseline, 6 hours, and at organ procurement (15-24 hrs) | 
| lactate |  | Baseline, 6 hours, and at organ procurement (15-24 hrs) | 
| Urinary isoprostanes |  | Baseline, 6 hours, and at organ procurement (15-24 hrs) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain-death, organ donation