Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:
Michael P Bokoch

Description

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.

Official Title

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

Details

This study is a single-blinded, randomized controlled trial of mild hypothermia during liver transplantation to provide protection from AKI. Participants will be randomized to normothermia (36.5-37.5 °C) versus mild hypothermia (34-35 °C) during a portion of the liver transplant operation. The protocol is based on preliminary data from rodent models showing that hypothermia protects the kidneys from ischemia-reperfusion injury, as well as studies in deceased organ donors showing that cooling improves post-transplant organ function. Temperature will be maintained with standard techniques plus a minimally-invasive esophageal cooling device that is approved by the U.S. Food and Drug Administration. The investigators hypothesize that mild hypothermia will reduce the incidence and severity of AKI after LTx. Standard surrogates (e.g., change in serum creatinine, need for initiation of dialysis) and biomarkers will be used to assess the severity of kidney injury.

Keywords

Cirrhosis End Stage Liver Disease Acute Kidney Injury Liver Transplant; Complications Chronic Kidney Diseases Hepatitis c Hepatitis B NASH - Nonalcoholic Steatohepatitis Alcoholic Cirrhosis Hepatocellular Carcinoma Hypothermia NGAL - Neutrophil Gelatinase-associated Lipocalin Wounds and Injuries Hepatitis Hepatitis A Kidney Diseases Carcinoma, Hepatocellular Renal Insufficiency, Chronic Fibrosis Liver Cirrhosis Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Liver Cirrhosis, Alcoholic Esophageal cooling/warming device Mild hypothermia Normothermia Mild hypothermia & Esophageal cooling/warming device Normothermia & Esophageal cooling/warming device

Eligibility

You can join if…

Open to people ages 18 years and up

  • Liver transplantation from a donor after neurologic determination of death

You CAN'T join if...

  • Liver transplantation from a donor after cardiac death
  • Acute liver failure
  • Living-donor liver transplantation
  • Simultaneous liver-kidney transplantation
  • Preoperative renal replacement therapy
  • Preoperative intubation
  • Pulmonary hypertension
  • Subject unable to read, speak, or understand English

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03534141
Lead Scientist
Michael P Bokoch
Study Type
Interventional
Last Updated
July 9, 2018