Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer, Renal Impairment / Chronic Kidney Disease, Hospital, Hospital, Gastrointestinal, Gastrointestinal, Gastrointestinal, Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases, Nephrology / Urology, Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/12/2018 |
| Start Date: | July 7, 2018 |
| End Date: | June 2021 |
| Contact: | Michael P Bokoch, MD, PhD |
| Email: | Michael.Bokoch@ucsf.edu |
| Phone: | (650) 387-4314 |
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation (MHALT) Trial
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.
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.
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.
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.
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
- Pulmonary hypertension
- Subject unable to read, speak, or understand English
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