NCT02158182已完成4 期
Comparison of Three Different Schemes:Lactulose, L-ornithine L-aspartate, or Rifaximin, Versus Placebo, as Primary Prophylaxis of the Development of Hepatic Encephalopathy After Acute Variceal Bleeding in Cirrhotic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Development of clinical hepatic encephalopathy
研究概览
简要总结
The aim of this study is to determine whether lactulose, L-ornithine L-aspartate, and rifaximin are effective in the prevention of the development of hepatic encephalopathy in cirrhotic patients with acute variceal bleeding
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Cirrhotic patients with acute variceal bleeding, without minimal or clinical hepatic encephalopathy according to PHES, CFF and West-Haven criteria
排除标准
- •Age under 18 year-old or over 65 year-old, with any other neuropsychiatric disorder or dementia, presence of active bacterial or fungal infections, receiving antibiotics for any cause, previous diagnosis of hepatic encephalopathy and receiving therapy with lactulose, rifaximin, L-ornithine L-aspartate, source of bleeding different from variceal origin, serum creatinine greater than 2.0 mg/dl or with chronic renal failure. Therapy in the previous six months with any of the drugs that will be used in this clinical trial.
研究组 & 干预措施
lactulose
Experimental
干预措施: Lactulose (Drug)
L-ornithine L-aspartate
Experimental
干预措施: L-ornithine L-aspartate (Drug)
Rifaximin
Experimental
干预措施: Rifaximin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Development of clinical hepatic encephalopathy
时间窗: 7 days
Determined by West-Haven Criteria
次要结局
- Development of minimal hepatic encephalopathy(7 days)
研究者
MARIA DE FATIMA HIGUERA DE LA TIJERA
MD, MSc.
Hospital General de Mexico
研究点 (1)
Loading locations...
相似试验
撤回
3 期
A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal FailureHepatic EncephalopathyNCT02086825NYU Langone Health
已完成
4 期
A clinical trial to compare Rifaximin with Lactulose in improving psychometric test performance in patients with cirrhosis and minimal hepatic encephalopathy.CTRI/2010/091/003045Department of Gastroenterology112
招募中
3 期
Comparison between rifaximin vs lactulose for treatment of hepatic encephalopathyhepatic encephalopathytreatment of hepatic encephalopathyrifaximinlactuloseTCTR20180509001Bio-innova and Synchron Co., Ltd80
已完成
不适用
Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized TrialHepatic EncephalopathyNCT01218568Institute of Liver and Biliary Sciences, India120
已完成
3 期
Pharmacokinetic Comparison Of All FK-506 FormulationsRenal FailureNCT02339246Veloxis Pharmaceuticals32