The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Patients With Ascites: A Multi-center, Randomized, Double-blind, Placebo-controlled, Investigator Initiated Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 188
- 试验地点
- 8
- 主要终点
- Change in serum albumin level
研究概览
简要总结
To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic patients with ascites.
详细描述
Branched-chain amino acid (BCAA) is known to reduce the relapse rate of liver cancer as it is associated with insulin resistance and has been reported to improve the progression of liver fibrosis when used in combination with an angiotensin-converting enzyme. With regard to the effect of liver function improvement, in a research conducted in South Korea, approximately 41.2% of the patients showed recovery of the normal albumin level when BCAA was administered to them for about 10 weeks during radiation therapy for liver cancer. Additionally, in other overseas researches, the changes in the values of total protein and albumin were significantly smaller in the patients who underwent transarterial chemoembolization (TACE) to whom BCAA was administered than in those to whom BCAA was not administered.
The hypothesis of this study is that the serum albumin value will be increased significantly in the cirrhotic patients with ascites to whom BCAA is administered than the patients to whom placebo is administered.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 and ≤ 70 years;
- •Presence of liver cirrhosis
- •Serum albumin level ≤ 3.5g/dl, ultrasound or CT scan confirmed ascites (≥Grade 1)
- •No administration of diuretics and BCAA within the past 1 week
- •Voluntary consent to take part in this trial
排除标准
- •Child-Pugh score > 12
- •Having been diagnosed as HCC within the past 5 years
- •Serum creatinine > 1.5mg/dl
- •Serum bilirubin > 5.0mg/dl
- •Presence of such complications as SBP, or hepatic encephalopathy(West Haven grade ≥ 3)
- •Patients who experienced organ failure by acute exacerbation of liver cirrhosis within the past 1 month
- •Presence of serious cardiac or respiratory disease
- •Contraindicated to either diuretics or BCAA
- •Having commenced anti-viral treatment against hepatitis C, B within the past 1 month
- •Pregnant or lactating women
- •Chronic alcohol taker
- •Woman patients who do not agree to the contraception from baseline to 12 month
- •Unsuitable patients judged by investigator
- •Patients participating in another clinical trial within 1 month
研究组 & 干预措施
BCAA group
Branched-chain amino acid, 4.15g, Tid
干预措施: Branched-chain Amino Acid (Drug)
Placebo group
Placebo, 4.15g, Tid
干预措施: Placebo (Drug)
结局指标
主要结局
Change in serum albumin level
时间窗: 24 week
次要结局
- Development rate of cirrhotic complications(including acute kidney injury, hepatic encephalopathy, variceal bleeding, peritonitis, etc)(24 week)
- Improvement in sarcopenia(24 week)
- Change in muscle mass(24 week)
- Change in serum albumin level(12 week)
- Change in dose of diuretics(12, 24 week)
- Improvement in terms of severity of ascites (International Ascites Club grade)(24 week)
- Improvement in Child-Pugh score, class(24 week)
- Change in muscle strength(24 week)
- Change in HOMA-IR(homeostatic model assessment-insulin resistance)(24 week)
- Rates of albumin normalization(12, 24 week)
- Change in MELD, MELD-Na(24 week)
- Improvement in SF-36(short form-36)(24 week)
研究者
Sang Gyune Kim
Associate professor
Soonchunhyang University Hospital