Clinical trial · Interventional
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation (MHALT) Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated 9/24/23 at 85% target enrollment due to slow accrual of subjects. The decline in enrollment was attributed to changing surgical demographics (higher MELD, more DCD grafts, and increasing use of Normothermic Perfusion technology).
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Kidney Injury | — | UNRESOLVED | — |
| Alcoholic Cirrhosis | — | UNRESOLVED | — |
| Chronic Kidney Diseases | — | UNRESOLVED | — |
| Cirrhosis | — | UNRESOLVED | — |
| End Stage Liver Disease | — | UNRESOLVED | — |
| Hepatitis B | — | UNRESOLVED | — |
| Hepatitis c | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Transplant; Complications | — | UNRESOLVED |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esophageal cooling/warming device | Device | — | UNRESOLVED |
| Mild hypothermia | Other | — | UNRESOLVED |
| Normothermia | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mild hypothermia & Esophageal cooling/warming device
- description
- The target core temperature is 34-35 °C.
- interventionNames
- Device: Esophageal cooling/warming device
- Other: Mild hypothermia
- type
- ACTIVE_COMPARATOR
- label
- Normothermia & Esophageal cooling/warming device
- description
- The target core temperature is 36.5-37.5 °C.
- interventionNames
- Device: Esophageal cooling/warming device
- Other: Normothermia
Primary outcomes (1)
- measure
- Acute Kidney Injury (AKI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDNiemann 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
- BACKGROUNDAngeli P, Gines P, Wong F, Bernardi M, Boyer TD, Gerbes A, Moreau R, Jalan R, Sarin SK, Piano S, Moore K, Lee SS, Durand F, Salerno F, Caraceni P, Kim WR, Arroyo V, Garcia-Tsao G; International Club of Ascites. Diagnosis and management of acute kidney injury in patients with cirrhosis: revised consensus recommendations of the International Club of Ascites. Gut. 2015 Apr;64(4):531-7. doi: 10.1136/gutjnl-2014-308874. Epub 2015 Jan 28. No abstract available. PMID 25631669
- BACKGROUNDNiemann CU, Walia A, Waldman J, Davio M, Roberts JP, Hirose R, Feiner J. Acute kidney injury during liver transplantation as determined by neutrophil gelatinase-associated lipocalin. Liver Transpl. 2009 Dec;15(12):1852-60. doi: 10.1002/lt.21938. PMID 19938135
- BACKGROUNDKalasbail P, Makarova N, Garrett F, Sessler DI. Heating and Cooling Rates With an Esophageal Heat Exchange System. Anesth Analg. 2018 Apr;126(4):1190-1195. doi: 10.1213/ANE.0000000000002691. PMID 29283916
- BACKGROUNDKarapanagiotou A, Dimitriadis C, Papadopoulos S, Kydona C, Kefsenidis S, Papanikolaou V, Gritsi-Gerogianni N. Comparison of RIFLE and AKIN criteria in the evaluation of the frequency of acute kidney injury in post-liver transplantation patients. Transplant Proc. 2014 Nov;46(9):3222-7. doi: 10.1016/j.transproceed.2014.09.161. PMID 25420865
- BACKGROUNDKellum JA, Zarbock A, Nadim MK. What endpoints should be used for clinical studies in acute kidney injury? Intensive Care Med. 2017 Jun;43(6):901-903. doi: 10.1007/s00134-017-4732-1. Epub 2017 Mar 2. No abstract available. PMID 28255614