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

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Alcoholic Cirrhosis; Hepatitis c; Chronic Kidney Diseases; Liver Transplant; Complications; Cirrhosis; Acute Kidney Injury; Hepatocellular Carcinoma; Hepatitis B; NASH - Nonalcoholic Steatohepatitis; End Stage Liver Disease

Treatments: Device: Esophageal cooling/warming device; Other: Normothermia; Other: Mild hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT03534141

17-22384

Details and patient eligibility

About

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.

Full description

This study is a 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 liver transplantation(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.

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Liver transplantation from a donor after neurologic determination of death

Exclusion criteria

• 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
• Portopulmonary hypertension
• Machine perfusion of liver graft

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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175 participants in 2 patient groups

Mild hypothermia & Esophageal cooling/warming device

Experimental group

Description:

The target core temperature is 34-35 °C.

Treatment:

Other: Mild hypothermia

Device: Esophageal cooling/warming device

Normothermia & Esophageal cooling/warming device

Active Comparator group

Description:

The target core temperature is 36.5-37.5 °C.

Treatment:

Other: Normothermia

Device: Esophageal cooling/warming device