NCT01175538Unknown4 期
Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis: an Open Labeled Randomized Controlled Trial of Lactulose Versus no Lactulose
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 试验地点
- 1
- 主要终点
- prevention of first episode of hepatic encephalopathy
研究概览
简要总结
To assess the effects of lactulose for the prevention of first episode of altered sensorium (hepatic encephalopathy, primary prophylaxis) in patients with cirrhosis.
详细描述
Development of hepatic encephalopathy in a patient with cirrhosis is associated with poor survival rate of 10-70% at one year depending upon hepatic and renal functions. Treating patients to prevent development of first episode of hepatic encephalopathy is classified as primary prophylaxis of hepatic encephalopathy and preventing recurrence of hepatic encephalopathy in patients who had previous episode of hepatic encephalopathy is secondary prophylaxis of hepatic encephalopathy
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cirrhotic patients(18-70yrs) who never had encephalopathy
排除标准
- •history of taking lactulose in the past 6 weeks
- •alcohol intake during the past 6 weeks
- •hepatocellular carcinoma
- •previous TIPS or shunt surgery
- •significant co morbid illness such as heart, respiratory, or renal failure
- •neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies.
- •patients on psychoactive drugs such as antidepressants or sedatives
- •who restarted alcohol during follow up
研究组 & 干预措施
Lactulose
Experimental
干预措施: Lactulose (Drug)
结局指标
主要结局
prevention of first episode of hepatic encephalopathy
时间窗: 6 months
次要结局
- Side effects to lactulose and mortality(6 months)
研究者
研究点 (1)
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