Hemodynamic Response of Rifaximin and Non-selective β-blocker Combination Therapy Versus Non-selective β-blocker Monotherapy in Cirrhotic Patients With Esophageal Varices
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Hepatic vein pressure gradient(HVPG)
研究概览
简要总结
To reduce portal pressure, the only recommended medication is nonselective beta blocker(NSBB). However, NSBB has some limitation to apply clinically because of poor response rate and compliance.
Recent literature has supported the role of bacterial translocation as a mediator of splanchnic vasodilatation and portal hypertension. This stimulates the release of pro-inflammatory cytokines and the activation of the vasodilator NO resulting in a more pronounced deterioration of the baseline hyperdynamic circulatory state. Selective gut decontamination with Rifaximin can induce inhibition of bacterial translocation and associated worsening of portal hypertension. The investigators hypothesized that Rifaximin plus NSBB could result in decrease of portal pressure in cirrhotic patients with esophageal varices.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis:diagnosed based on histology or unequivocal clinical, sonographic, and laboratory findings
- •19≤age≤75
- •Hepatic venous pressure gradient > 12 mmHg
- •Informed consent
排除标准
- •Shock status requiring vasopressor
- •Active infection, for example Spontaneous bacterial peritonitis
- •Acute renal failure patients of any cause
- •Clinically relevant coronary artery disease(NYHA functional angina classification III/IV),congestive heart failure NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the past 12 months
- •Poorly controlled hypertension (BP 150/100mmHg)
- •Hepatocellular carcinoma
- •History of another primary malignancy ≤ 3years
- •Medical or psychological conditions that would not permit the subject to complete thte study or sign informed consent
- •Pregnancy or lactation period
- •Serum creatinine ≧ 6mg/dL
- •Involvement in the conduct of other study within 30 days
- •Known hypersensitivity to Rifaximin or propranolol
- •Dysarrhythmia, inappropriate for study on investigator's judgment
研究组 & 干预措施
Combination therapy
Rifaximin(normix®)+nonselective beta-blocker(Propranolol)
干预措施: Rifaximin + propranolol (Drug)
Monotherapy
nonselective beta-blocker(Propranolol) + Placebo(of Rifaximin)
干预措施: Propranolol + Placebo (Drug)
结局指标
主要结局
Hepatic vein pressure gradient(HVPG)
时间窗: Change from baseline heptic vein pressure gradient at 6 weeks
After measurement of baseline HVPG, patients will be randomized to treatment group of Rifaximin + Propranolol or Propranolol + Placebo. And 6 weeks after treatment, follow-up measurement of HVPG will be performed to evaluate efficacy of two regimens
次要结局
- occurence of gastrointestinal bleeding(upto 6 months after initiation of treatment)
研究者
Moon Young Kim
Associate Professor, Divistion of Gastroenterology and Hepatology, Department of Internal Medicine
Yonsei University