NCT00748904撤回4 期
A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Progressive Renal Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- slower progression to severe hepatic encephalopathy, stage 3 or 4
研究概览
简要总结
The purpose of this study is to evaluate patients with cirrhosis of the liver and renal failure and determine if the administration of rifaximin as compared to lactulose is associated with less frequent and/or slower progression to severe hepatic encephalopathy. If one is associated with lower blood ammonia levels. And, if one is associated with lower breath hydrogen and methane levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •cirrhosis of liver of any etiology
- •progressive renal failure
- •stage 0-2 hepatic encephalopathy
排除标准
- •pregnant women
研究组 & 干预措施
A
Experimental
35 patients receiving rifaximin
干预措施: Rifaximin (Drug)
B
Experimental
35 patients receiving lactulose
干预措施: Lactulose (Drug)
结局指标
主要结局
slower progression to severe hepatic encephalopathy, stage 3 or 4
时间窗: during hospitalization
次要结局
未报告次要终点
研究者
研究点 (1)
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