Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease (BRAVE): Korean Nation-wide Multicenter Retrospective and Prospective Observational Cohort Study
试验速览
- 阶段
- 4 期
- 入组人数
- 1,470
- 试验地点
- 1
- 主要终点
- End-Stage Liver Disease score was calculated using serum total bilirubin, creatinine, international normalized ratio
研究概览
简要总结
Protein-calorie malnutrition is frequently observed in patients with advanced liver cirrhosis. There have been continued interests in potential benefits of long-term oral branched-chain amino acid supplement in improving severity of liver disease. However, there are limited evidences in literature. The aim of this study is to evaluate the efficacy of oral branched-chain amino acid in patients with advanced liver cirrhosis.
详细描述
This study is a multicenter retrospective cohort study involving thirteen centers in Korea nation-wide. The inclusion criteria are liver cirrhosis patients with Child-Pugh score 8 to 10. The major exclusion criteria are abnormal serum creatinine level, and hepatocellular carcinoma with viable tumor. The investigators analyzed improvement of Model for End-Stage Liver Disease score, Child-Pugh score, incidence of cirrhosis-related complications, and event free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced liver cirrhosis patients with Child-Pugh score 8 to 10
排除标准
- •Diagnosis of malignancy (except hepatocellular carcinoma) within 3 years or untreated malignancy
- •Major organ failure (heart, lung and kidney) need to admission or medical therapy or dialysis
- •Patients already on a waiting list or being considered for major organ transplantation.
- •Serum creatinine above upper normal range (>1.5 mg/dL)
- •Patients treating with albumin replacement regularly
- •Viable hepatocellular carcinoma or advanced Barcelona Clinic Liver Cancer stage or hepatocellular carcinoma below 6 months life expectancy
- •Patients being impossible to secession of alcohol consumption
- •Patients being impossible to oral ingestion or oral medication
- •Pregnancy or being considered for pregnancy
- •Breast feeding
- •Amyotrophic lateral sclerosis
- •Patients with other metabolic disorder presenting branched-chain ketoaciduria
研究组 & 干预措施
Livact
Daily dose of 12.45g of branched-chain amino acid containing 3.4g of L-valine, 5.7g of L-leucine, and 2.9g of L-isoleucine over 6 months.
干预措施: Livact (Drug)
结局指标
主要结局
End-Stage Liver Disease score was calculated using serum total bilirubin, creatinine, international normalized ratio
时间窗: After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death
次要结局
- Incidence of cirrhosis-related complications including death(After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death)
研究者
Won Young Tak
Division of Gastroenterology & Hepatology
Kyungpook National University Hospital