Randomized Double Blind Placebo Controlled Trial of Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
试验速览
- 阶段
- 3 期
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Development of Clinically Overt Hepatic Encephalopathy
研究概览
简要总结
To evaluate the role of lactulose in prevention of clinically overt hepatic encephalopathy (HE) in the setting of acute upper gastrointestinal bleeding in cirrhotic patients
详细描述
Variceal hemorrhage occurs in 25 to 35 % of patients with cirrhosis and accounts for 80 to 90% of bleeding episodes in these patients. Around 25-30 percent of patients develop hepatic encephalopathy. Development of hepatic encephalopathy in patients with gastrointestinal bleed can cause increase morbidity with higher hospital costs in these patients. To date no randomized trial has been done in terms of prevention of encephalopathy in gastrointestinal hemorrhage. One trial has compared lactulose in combination with antibiotic against mannite, showed equal efficacy in both groups. No study has been done evaluate the efficacy of lactulose in prevention of encephalopathy in these patients.
We hypothesize that prophylactic use of Lactulose decreases the risk of development of hepatic encephalopathy with upper GI bleed in cirrhotics.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •All acute gastrointestinal bleeding in cirrhotics without hepatic encephalopathy at the time of admission in ER
排除标准
- •Increased α-fetoprotein level/ Documented hepatoma
- •Portal or hepatic vein thrombosis
- •Large-volume or tense ascites requiring repeated therapeutic paracentesis
- •Serious recurrent or ongoing co morbid illness (e.g., severe renal, cardiac, or respiratory failure; sepsis)
- •Pregnancy
- •Not willing to give consent to participate in the study
- •Patients who are unable to read and write
- •ER arrival time > 12 hrs from index bleed
研究组 & 干预措施
1
Lactulose 30 ml q6h for 48 hrs
干预措施: Lactulose (Drug)
2
Placebo 30 ml q6 hrly for 48hrs
干预措施: Placebo (Drug)
结局指标
主要结局
Development of Clinically Overt Hepatic Encephalopathy
时间窗: 48hours
次要结局
- Death, hospital stay(48hrs)