The Effect of Therapeutic Hypothermia on Deceased Donor Renal Graft Outcomes - a Randomized Controlled Trial From the Region 5 Donor Management Goals Workgroup

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
California Transplant Donor Network
Information provided by (Responsible Party):
Claus Niemann, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01680744
First received: August 21, 2012
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

To protect kidney function during the transplantation process by inducing mild hypothermia in the deceased organ donor before organs are recovered


Condition Intervention
Deceased Organ Donor
Mild Hypothermia
Renal Function
Other: Hypothermia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Renal Function [ Time Frame: 12 hours of mild hypothermia ] [ Designated as safety issue: No ]
    The primary outcome measures are renal function as determined by creatinine and cystatin c between declaration of neurological death and organ recovery in each of the two treatment groups. Delta creatinine and terminal creatinine are important predictors of graft quality and function, as demonstrated in the present data (HRSA study and Region 5 DMG/DGF study), and will be compared between the control and treatment group.


Estimated Enrollment: 500
Study Start Date: May 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypothermia
The intervention will take place after consent for donation and research has been obtained and hemodynamic stability has been achieved (mean arterial blood pressure > 60 mmHg for more than one hour without an increase in vasopressors). Organ donors in the experimental group will either be actively warmed or allowed to spontaneously reach a body temperature of 34 °C.
Other: Hypothermia
The intervention will take place after consent for donation and research has been obtained and hemodynamic stability has been achieved (mean arterial blood pressure > 60 mmHg for more than one hour without an increase in vasopressors). Organ donors in the experimental group will either be actively warmed or allowed to spontaneously reach a body temperature of 34 °C.
Other Name: Hypothermia
No Intervention: Standard Treatment

Detailed Description:

The number of kidneys available for transplantation in the U.S. (~15,000/yr) does not meet demand (~80,000/yr). This discrepancy will likely worsen given the increasing U.S. prevalence of chronic kidney disease and is compounded by sizable organ attrition once organs have entered the donation process (25-30% attrition in Region 5). Furthermore, worsening renal function in donation after neurologic determination of death (DNDD) organ donors (an increasingly important source of allografts) is one of the strongest predictors of delayed graft function (DGF) and slow graft function (SGF) in the recipient. Both DGF and SGF are associated with decreased long-term organ survival and are of major concern to the transplant community.

To alleviate the aforementioned supply-demand imbalance, there are two major unmet needs that must be urgently addressed. First, active medical interventions that are tested prospectively to protect the organ during the donation process hold sizable potential, but remain exceedingly rare. Second, compliance with pre-defined donor management protocols to restore and stabilize deceased organ donor physiologic functions remains low across different donation service areas, despite evidence that these protocols may improve organ yield.

The goal of this proposal, therefore, is to demonstrate that (1) therapeutic hypothermia as an active medical intervention for the DNDD donor and (2) compliance with donor management protocols can substantially improve allograft function and survival.

The investigators will accomplish this goal by extending an existing research infrastructure (HRSA, R380T10586) across several donor service areas. As such, the investigators will bring together a research network and use the power of this network to properly test a simple medical intervention, therapeutic hypothermia for renal protection, in a prospective randomized single blinded trial. Therapeutic hypothermia is an established cytoprotective intervention that has been demonstrated to be highly protective of organs in select critically ill patients. By combining two of the largest donation service areas in the nation (CTDN, Northern California and OneLegacy, Southern California), the investigators will have access to approximately 10% of all organ donors in the nation. This proposal aims to randomize 500 DNDD organ donors, the biggest cohort enrolled in a prospective randomized trial.

The investigators will further leverage this network to track trial specific donor management protocols variables goals and drive tighter compliance with already established donor management protocols across all donor service areas in Region 5. This will allow the investigators to compile a large historical control cohort that will facilitate answering additional research questions with great detail. All organ procurement areas in Region 5 have confirmed their willingness to participate in this effort and contribute relevant organ donor data via a shared web-portal. Through this active participation, a secondary gain will be improved reporting of donor data and compliance with already accepted donor management goals.

Test of feasibility will be improvement in various kidney function metrics that are commonly used to evaluate organ health during the donation process. Ultimately, the investigators believe this multi-pronged approach may lead to 800 to 1000 additional kidneys that are successfully transplanted nationwide each year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years of age, deceased organ donor

Exclusion Criteria:

  • < 18 years of age, not a deceased organ donor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680744

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
California Transplant Donor Network
  More Information

No publications provided

Responsible Party: Claus Niemann, Professor of Anesthesia & Surgery, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01680744     History of Changes
Other Study ID Numbers: R38OT22183
Study First Received: August 21, 2012
Last Updated: October 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Transplantation
Terminal creatinine
Renal function
GFR

Additional relevant MeSH terms:
Death
Hypothermia
Pathologic Processes
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014