Mild Hypothermia and Acute Kidney Injury in Liver Transplantation (MHALT) Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies). Patients who experience AKI after liver transplantation have higher mortality, increased graft loss, longer hospital and intensive care unit stays, and more progression to chronic kidney disease compared with those who do not. In this study, half of the participants will have their body temperature cooled to slightly lower than normal (mild hypothermia) for a portion of the liver transplant operation, while the other half will have their body temperature maintained at normal. The study will evaluate if mild hypothermia protects from AKI during liver transplantation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Liver transplantation from a donor after neurologic determination of death

Locations
United States
California
University of California, San Francisco
Recruiting
San Francisco
Colorado
University of Colorado Anschutz Medical Campus
Recruiting
Aurora
Texas
Houston Methodist Hospital
Recruiting
Houston
Contact Information
Primary
Michael P Bokoch, MD, PhD
Michael.Bokoch@ucsf.edu
(415) 476-8389
Backup
Claus U Niemann, MD
Claus.Niemann@ucsf.edu
(415) 502-2162
Time Frame
Start Date: July 7, 2018
Estimated Completion Date: December 31, 2023
Participants
Target number of participants: 230
Treatments
Experimental: Mild hypothermia & Esophageal cooling/warming device
The target core temperature is 34-35 °C.
Active Comparator: Normothermia & Esophageal cooling/warming device
The target core temperature is 36.5-37.5 °C.
Sponsors
Collaborators: The Methodist Hospital Research Institute, University of Colorado, Denver
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov

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