NCT01440829已完成2 期
The Effectiveness of L-ornithine-L-aspartate on Plasma Ammonia in Cirrhotic Patients After TIPS Procedure: a Prospective, Randomized, Controlled, Open-label Clinical Trial
Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Plasma ammonia
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of L-ornithine-L-aspartate (LOLA) on plasma ammonia in cirrhotic patients after Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure.
详细描述
Patients with successful TIPS deployment are randomized to LOLA arm and blank control arm. Plasma ammonia concentrations are measured before TIPS, day 1, day 4 and day 7 after TIPS.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic patients with refractory ascites or at least one episode of variceal bleeding
- •No active bleeding within 5 days before TIPS
- •Child-Pugh score ≤ 11
- •Signed written informed consent
排除标准
- •An age < 18 years or > 65 years
- •With TIPS contraindications
- •Using drugs for hepatic encephalopathy such as neomycin, rifaximin, lactulose, lactitol or branched-chain amino acid.
- •Intake of psychostimulants, sedatives, antidepressants, benzodiazepines or benzodiazepine-antagonists
- •Past or present history of hepatic encephalopathy
- •Pregnancy or breast-feeding
- •Hepatic carcinoma and/or other malignancy diseases
- •Spontaneous bacterial peritonitis
- •Uncontrollable hypertension
- •Serious cardiac or pulmonary dysfunction
- •Renal failure
- •Portal vein thrombosis
- •History of organ transplantation
- •History of HIV (human immunodeficiency viruses) infection
研究组 & 干预措施
LOLA group
Experimental
Intervention: LOLA (30g per day) for a week.
干预措施: L-ornithine-L-aspartate (Drug)
结局指标
主要结局
Plasma ammonia
时间窗: One week
The plasma ammonia concentrations of venous blood at the first, fourth and seventh days after TIPS procedure.
次要结局
- Incidence of hepatic encephalopathy(One week)
- Liver function(One week)
- Psychometric tests(One week)
研究者
Guohong Han
Principal Investigator
Air Force Military Medical University, China
研究点 (1)
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