NCT02991612已完成不适用
Efficacy of Rafiximin in Patients With Cirrhotic Gastroesophageal Variceal Hemorrhage: A Single-center Pilot Study
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年11月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of all clinical adverse events
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.
详细描述
Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection.
However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 y.o. ≤age≤75 y.o.;
- •Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N- butyl-cyanoacrylate injection).
排除标准
- •age <18 y.o. or age > 75 y.o.;
- •Never had the variceal bleeding episode before;
- •Do not have endoscopic treatment;
- •Combined with other malignant tumors (not exclude patients with hepatocellular carcinoma who don't need treatment at the moment);
- •Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
- •Massive ascites or combined with other high-risk factors that require prophylaxis use of antibiotics.
- •Acute variceal bleeding within 5 days.
- •Refuse to participate
研究组 & 干预措施
Rifaximin Treatment Group
Experimental
Rifaximin 400mg bid for 2 months,
干预措施: Rifaximin (Drug)
结局指标
主要结局
Incidence of all clinical adverse events
时间窗: 8 weeks
The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks
次要结局
- Changes of portal vein thrombosis(2 months)
- Changes of intestinal flora(2 months)
- The changes of serum level of cytokines(8 weeks)
研究者
Shiyao Chen
Professor
Shanghai Zhongshan Hospital
研究点 (1)
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