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

NCT01680744 | Completed DMC

• 1 other identifier: R38OT22183
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Deceased Organ Donor; Mild Hypothermia; Renal Function

Keywords

Transplantation; Terminal creatinine; Renal function; GFR

Outcome Measures

Primary Outcomes (1)

• Renal Function

  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.

  12 hours of mild hypothermia

Study Arms (2)

Hypothermia

EXPERIMENTAL

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

Standard Treatment

NO INTERVENTION

Interventions

Hypothermia OTHER

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.

Hypothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age, deceased organ donor

You may not qualify if:

• \< 18 years of age, not a deceased organ donor

Sponsors & Collaborators

• University of California, San Francisco: lead
• California Transplant Donor Network: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (3)

• Malinoski D, Patel MS, Axelrod DA, Broglio K, Lewis RJ, Groat T, Niemann CU. Therapeutic Hypothermia in Organ Donors: Follow-up and Safety Analysis. Transplantation. 2019 Nov;103(11):e365-e368. doi: 10.1097/TP.0000000000002890.

  PMID: 31356580 DERIVED

• Axelrod DA, Malinoski D, Patel MS, Broglio K, Lewis R, Groat T, Lentine KL, Schnitzler M, Niemann CU. Modeling the economic benefit of targeted mild hypothermia in deceased donor kidney transplantation. Clin Transplant. 2019 Jul;33(7):e13626. doi: 10.1111/ctr.13626.

  PMID: 31162858 DERIVED

• Niemann CU, Feiner J, Swain S, Bunting S, Friedman M, Crutchfield M, Broglio K, Hirose R, Roberts JP, Malinoski D. Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function. N Engl J Med. 2015 Jul 30;373(5):405-14. doi: 10.1056/NEJMoa1501969.

  PMID: 26222557 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia & Surgery

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: September 7, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

US (1)