Comparative Effectiveness Of Polyethylene Glycol Electrolyte Solution Versus Lactulose For Treatment Of Hepatic Encephalopathy : A Single Blind, Randomised Control Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1 or more scale improvement in HE grades at 24 hours, 48 hours, 72 hours and at time of discharge using Hepatic Encephalopathy Scoring Algorithm (HESA) ranging from 0 to 4
研究概览
简要总结
lactulose has been recommended as a guide to HE for decades, which is able to reduce the intestinal production and absorption of ammonia generated by catharsis and intestinal microbial metabolism. although lactulose is the standard therapy for gut catharsis in HE patients, PEG can also relieve constipation and reduce the absorption of ammonia.
PEG is an iso-osmotic laxative that is metabolically inert and ablr to bind water molecules, thereby increasing intraluminal water retention. PEG is not metabolized by colonic bacteria. ingestion og PEG leads to an increase in stool volume and softer stools, which may become liquid depending on the volume of PEG consumed. it is the most widely used preparation to clean the bowel before colonoscopy.
PEG is being studied for treatment of HE in patients with cirrhosis and limited research has shown positive effects. there are very few studies comparing lactulose and PEG in HE, and indian data on this comparison is lacking.
since PEG is a safe, affordable, widely available and highly effective osmotic laxative, we hypothesize that if immediate catharsis of gut is important in the treatment of acute HE, then PEG may be superior to lactulose in this capacity. thus, this study aims to determine the effect of PEG compared with lactulose for HE therapies by conducting a randomised control trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with any grade of hepatic encephalopathy (grade1-grade4) 2.Patients with chronic liver disease and acute on chronic liver failure of any cause.
排除标准
- •patients with acute liver failure, suspected intestinal obstruction, pregnancy and lactation, uncontrolled infection and hemodynamically unstable and received more than 1 dose of lactulose prior to enrollment.
结局指标
主要结局
1 or more scale improvement in HE grades at 24 hours, 48 hours, 72 hours and at time of discharge using Hepatic Encephalopathy Scoring Algorithm (HESA) ranging from 0 to 4
时间窗: 12 months
次要结局
- overall length of stay (LOS), serum ammonia concentration and time to HE resolution.(12 months)
研究者
Dr Aditi Agrawal
Dr. S.N. Medical College, Jodhpur