Mild Hypothermia and Acute Kidney Injury in Liver Transplantation (MHALT) Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 171
- 试验地点
- 6
- 主要终点
- Acute Kidney Injury (AKI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver transplantation from a donor after neurologic determination of death
排除标准
- •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
结局指标
主要结局
Acute Kidney Injury (AKI)
时间窗: 72 hours from the end of surgery
Acute Kidney Injury (AKI) is defined according to the International Club for Ascites (ICA) 2015 criteria, a revision of the Kidney Disease Improving Global Outcome (KDIGO) criteria for patients with cirrhosis (Angeli P, Ginès P, Wong F, Bernardi M, Boyer TD, Gerbes A, et al. Gut. 2015 Apr;64(4):531-7). AKI is defined as an increase in sCr ≥ 0.3 mg/dL within 48 hours, or a percentage increase ≥ 50% from baseline, or the initiation of renal replacement therapy. Baseline creatinine is defined as the most recent value obtained prior to liver transplantation.
次要结局
- Distribution of the Stages of Acute Kidney Injury (AKI)(72 hours from the end of surgery)
- Duration of Intensive Care Unit (ICU) Stay(Time from end of liver transplant to ICU discharge, approximately 1 to 3 days)
- Duration of Hospital Stay(Time from liver transplant to hospital discharge, approximately 1-2 weeks.)
- Patient Survival(up to 1 year)
- Persistent Renal Dysfunction(90 days and 1 year)
- Serum Neutrophil Gelatinase-associated Lipocalin (NGAL)(Baseline (start of surgery) and 2 hours after reperfusion of the portal vein)
- Need for Renal Replacement Therapy(72 hours, 30 days, and 1 year. The original protocol specified assessment at 1 week after surgery. However, this data was unable to be collected and we are only able to determine the outcome at 72 hours, 30 days, and 1 year.)
- Urine Neutrophil Gelatinase-associated Lipocalin (NGAL)(Baseline (start of surgery) and 2 hours after reperfusion of the portal vein)