Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Improvement of cognition
研究概览
简要总结
The purpose of this study is to evaluate whether the use of polyethylene glycol is superior and more safe in treating hepatic encephalopathy compared to lactulose and also to determine if treatment with polyethylene glycol will reduce the duration of hospital stay.
详细描述
Hepatic encephalopathy is the occurrence altered level of consciousness as a result of cirrhosis and liver failure. Main treatment goal for hepatic encephalopathy is to eliminate the precipitating factor and to decrease circulating ammonia level. Current standard for treating HE is treatment with Lactulose. Lactulose are metabolized by colonic bacteria to byproducts which cause catharsis and reduces pH, thereby inhibiting ammonia absorption. However, there is limited evidence available to demonstrate the efficacy. Studies on animal model have suggested that polyethylene glycol 3350-electrolyte solution (GOLYTELY) is effective in clearing gut bacteria and reducing the ammoniagenesis in colon. Recently published study by Robert Rahimi, University of Texas Southwestern Medical Center found that polyethylene glycol is more effective in improving HE over the first 24 hours compared to lactulose and also may reduce duration of hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 80
- •Male and female of all races and ethnicities
- •Cirrhosis of any cause
- •Any grade of hepatic encephalopathy (1-4)
- •Representatives have to be willing to comply with all protocol procedures and to understand, sign and date an informed consent document and authorize access to protected health information on the subject's behalf
排除标准
- •Acute liver failure
- •Prisoners
- •Structural brain lesions (as indicated by CT and confirmed by neurological exam)
- •Other causes of altered mental status
- •Previous use of rifaximin or neomycin within last 7 days
- •Pregnancy
- •Serum Na <125 MEq/liter
- •Receiving more than 1 dose (30 cc) of lactulose prior to enrollment
- •Uncontrolled infection with hemodynamic instability requiring vasopressors.
研究组 & 干预措施
Lactulose
per standard of care
干预措施: Lactulose (Drug)
polyethylene glycol 3350 (Golytely)
干预措施: Polyethylene Glycol 3350 (Drug)
结局指标
主要结局
Improvement of cognition
时间窗: 24 hours from the time of enrollment
Subjects will be evaluated every 24hr from the time of enrollment to assess for improvement of cognition until back to baseline and/or grade 0 based on HESA scare
次要结局
- Duration of hospital stay(From time of admission to time of discharge an approximate length of seven days)
研究者
Smruti R Mohanty, MD
Chief of Gastroenterology
New York Presbyterian Brooklyn Methodist Hospital