Early Postoperative Continuous Renal Replacement Therapy After Liver Transplantation in Acute-on-chronic Liver Failure Patients With Overt Hepatic Encephalopathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 主要终点
- Adverse events
研究概览
简要总结
Pretransplant hepatoencephalopathy (HE) markedly impacts recipient outcomes after liver transplantation. Intraoperative CRRT showed benefits but feasibility was much concerned. This study aims to observe the effect on consciousness recovery when initiating CRRT early in the post-transplant period in recipients with ACLF and overt HE.
详细描述
Hepatoencephalopathy (HE) is a common severe decompensation in end stage liver diseases and resulted to the need of liver transplantation (LT). Pretransplant HE markedly impacts recipient outcomes after liver transplantation. HE in acute on chronic liver failure (ACLF) is categorized to type C HE. Hyperammonemia and systemic inflammation have been reported to contribute its development. Continuous renal replacement therapy (CRRT) has been shown great benefits in ACLF patients with HE. Intraoperative CRRT in LT also showed benefits but feasibility was much concerned. Our preliminary retrospective data showed that early CRRT (eCRRT) after LT reduced consciousness recovery time, ventilation days and post-transplant infection rate.
This open label, parallel randomized trial will observe the effect on consciousness recovery when initiating CRRT early (eCRRT) in the post-transplant period in recipients with ACLF and overt HE.
The CRRT safety and ventilation days, infection, mortality and ICU stay will also be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver transplant recipients who meet all of the following criteria will be enrolled
- •Pre transplant liver failure: Total bilirubin over 171μmol/L and prothrombin activity (PTA)<40%;
- •Overt hepatic encephalopathy(HE): Grade II or higher HE according West Haven classification;
- •HE associated with acute liver failure (Type A) or cirrhosis complicated with portal hypertension and/or portal systemic shunts (Type C)
排除标准
- •Patients with a previous history of kidney-related diseases and glomerular filtration rate <30 millilitre per minute;
- •Patients with acute renal failure need CRRT before transplantation;
- •Patients newly developed acute renal failure need CRRT at the time of randomization;
- •Retransplantation or multiple-organs transplantation;
- •Any ischemic or hemorrhagic stroke co-morbidity;
- •Hemodynamic instability requiring fluid resuscitation or very high dose of vasopressors;
- •Extremely moribund patients with an expected life expectancy of less than 24 hours.
研究组 & 干预措施
eCRRT group
Initiated CRRT within the first 24 post-transplant hours.
干预措施: eCRRT (Device)
Control group
Standard treatment.
结局指标
主要结局
Adverse events
时间窗: From the immediate to 7 days after liver transplantation (CRRT therapy period)
Any adverse event which probable related with CRRT
Consciousness recovery time
时间窗: From the immediate to 30 days after liver transplantation
The period from post-transplant immediate to the time when the patient have the first spontaneous eye opening and proper motor response to commands.
次要结局
- Infection rate(From the immediate to 30 days after liver transplantation)
- Invasive ventilation days(From the immediate to 30 days after liver transplantation)
- ICU stay (days)(up to one year)
- 90 days mortality(From the immediate to 90 days after liver transplantation)
- Reintubation rate(From the immediate to 30 days after liver transplantation)
研究者
Huimin Yi
Principal Investigator and the director of transplant intensive care unit
Third Affiliated Hospital, Sun Yat-Sen University