NCT02931123Unknown1 期
A RCT COMPARING LACTULOSE AND RIFAXIMIN ASSOCIATED WITH A VEGETABLE DIET IN THE PREVENTION OF POST-TIPS OVERT HEPATIC ENCEPHALOPATHY
University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- incidence of hepatic encephalopathy
研究概览
简要总结
This is a randomized controlled trial whose purpose is to evaluate the efficacy of therapy with lactulose and rifaximin associated with a vegetable diet in the prevention of post-TIPS hepatic encephalopathy.
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
- •consecutive cirrhotic patients undergoing TIPS
排除标准
- •age >75 years; bilirubin levels >5 mg/dl; creatinine levels >3 mg/dl; a serious cardiac or pulmonary dysfunction; a Child-Pugh's score >11 (except for the patients candidates to early TIPS); a model end-stage liver disease (MELD) score >18; a diagnosis of hepatic carcinoma; sepsis; spontaneous bacterial peritonitis; renal insufficiency. Present HE or previous spontaneous/recurrent HE, alcohol/psychoactive drugs intake (positive alcoholaemia and/or benzodiazepines or opioid urine metabolites) at the moment of evaluation, unrelated neurological disease including dementia (mini mental state < 26).
研究组 & 干预措施
treatment
Experimental
rifaximine and lattulose plus low proteine diet
干预措施: lattulose and rifaximine (Drug)
结局指标
主要结局
incidence of hepatic encephalopathy
时间窗: one month
次要结局
未报告次要终点
研究者
Prof oliviero Riggio
professor
University of Roma La Sapienza
研究点 (1)
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