Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Change of overt HE.
研究概览
简要总结
Hepatic encephalopathy (HE), a fatal complication of decompensated cirrhosis, is characterized as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but the optimal dosage is obscure. Herein, a randomized controlled trial (RCT) aims to compare the efficacy of human albumin infusion at different dosages in cirrhotic patients with overt HE.
详细描述
Overall, 174 cirrhotic patients with a diagnosis of overt HE and a serum albumin level of 23-32g/L will be enrolled. They will be stratified according to the severity of overt HE and randomly assigned at a ratio of 1:1 into the groups of human albumin infusion at a modified dosage and a routine dosage. The primary endpoint is the improvement of overt HE within 5 days after treatment. The secondary endpoints include recurrence of overt HE, survival, and adverse events.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A definite diagnosis of liver cirrhosis and overt HE
- •A serum albumin level of 23-32g/L
- •Age ≥18 years old
- •Sign the informed consent
排除标准
- •Contraindications to human albumin infusion
- •A history of transjugular intrahepatic portosystemic shunt
- •A diagnosis of acute liver failure
- •Severe heart and/or lung diseases
- •Psychiatric or nervous diseases
- •Pregnant or lactating
研究组 & 干预措施
Routine dosage group
Intravenous infusion of human albumin 10-20g.
干预措施: Arginine (Drug)
Modified dosage group
Intravenous infusion of human albumin 30-60g.
干预措施: Human albumin infusion at a modified dosage (Drug)
Modified dosage group
Intravenous infusion of human albumin 30-60g.
干预措施: Lactulose (Drug)
Modified dosage group
Intravenous infusion of human albumin 30-60g.
干预措施: Rifaximin (Drug)
Modified dosage group
Intravenous infusion of human albumin 30-60g.
干预措施: Ornithine Aspartate (Drug)
Modified dosage group
Intravenous infusion of human albumin 30-60g.
干预措施: Branched-Chain Amino Acids (Drug)
Modified dosage group
Intravenous infusion of human albumin 30-60g.
干预措施: Arginine (Drug)
Routine dosage group
Intravenous infusion of human albumin 10-20g.
干预措施: Human albumin infusion at a routine dosage (Drug)
Routine dosage group
Intravenous infusion of human albumin 10-20g.
干预措施: Lactulose (Drug)
Routine dosage group
Intravenous infusion of human albumin 10-20g.
干预措施: Rifaximin (Drug)
Routine dosage group
Intravenous infusion of human albumin 10-20g.
干预措施: Ornithine Aspartate (Drug)
Routine dosage group
Intravenous infusion of human albumin 10-20g.
干预措施: Branched-Chain Amino Acids (Drug)
结局指标
主要结局
Change of overt HE.
时间窗: 3-5 days
The change of HE is defined as a decrease or an increase of at least one grade of the West Haven criteria after treatment.
次要结局
- Survival(3 months)
- Recurrence of overt HE.(3 months)
- Reversal of overt HE.(3-5 days)
- Adverse events(3 months)
研究者
Xingshun Qi
Director of Department of Gastroenterology
General Hospital of Shenyang Military Region