Rifaximin Predicts the Complications of Decompensated Cirrhosis: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Serum endotoxin level
研究概览
简要总结
Cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and increased intestinal permeability all leading to an increase in bacterial translocation and increased endotoxemia. Rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract. It has been suggested that oral prophylactic antibiotics or bowel decontamination might improve long-term outcomes in patients with cirrhosis. The aim of this study was to explore the suitable dose of rifaximin to alleviate endotoxemia and prevent the complications of advanced cirrhosis.
详细描述
Cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and increased intestinal permeability all leading to an increase in bacterial translocation and increased endotoxemia. Cirrhotics with bacterial translocation and endotoxemia manifest hemodynamic derangement with lower systemic vascular resistance, higher cardiac output, and lower mean arterial pressure. Moreover, endotoxins may increase portal pressure by increasing vascular resistance which may be promoted through the cytokine-stimulated intrahepatic release of endothelin and cyclo-oxygenase products.
Indeed, bacterial infections are common in cirrhotic patients and have approximately 30% mortality at one month and a further 30% mortality at 12 months as documented in a systematic review comprising almost 12 000 patients. It follows that altering gut flora to decrease endotoxin levels may lead to improved prognosis in cirrhosis. Rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract. It has been suggested that oral prophylactic antibiotics or bowel decontamination might improve long-term outcomes in patients with cirrhosis, not only by reducing the risk of infections but also by reducing hepatic vein pressure gradient (HVPG).
The aim of this study was to explore the suitable dose of rifaximin to alleviate endotoxemia and prevent the complications of advanced cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Decompensated cirrhosis
- •Child-Pugh B or C stage
排除标准
- •severe complications of cirrhosis in the past one month.
- •renal dysfunction.
- •administration of antibiotics in the past two weeks.
- •malignant tumors.
- •HIV infection.
- •severe heart and lung disease
- •sensitivity to rifaximin
- •Pregnancy and lactation woman
- •Patients who have took part in other clinical trials in the past three months.
研究组 & 干预措施
high dose of rifaximin
rifaximin 600 mg, bid, orally, 2 weeks and conventional treatment
干预措施: rifaximin (Drug)
low dose of rifaximin
rifaximin 400 mg bid,orally, 2 weeks
干预措施: rifaximin (Drug)
结局指标
主要结局
Serum endotoxin level
时间窗: 4 weeks
Hydrogen breath test
时间窗: 4 weeks
Fecal flora
时间窗: 4 weeks
次要结局
- Serum levels of inflammatory factors(4 weeks)
- Liver biochemistry tests(4 weeks)
- Numbers of complications of cirrhosis(4 weeks)
研究者
Wei-Fen Xie
Director
Shanghai Changzheng Hospital