To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Complete reversal of hepatic encephalopathy in both groups.
研究概览
简要总结
All patients presenting to the emergency department of Institute of Liver and Biliary Sciences with known cirrhosis and hepatic encephalopathy with grade II will be included in the study. The patient will be randomized into one of the two arms of lactulose or polyethylene glycol. The patient on the lactulose arm will be administered 20 to 30 g of lactulose orally or by nasogastric tube (3 or more doses within 24 hours ) or if oral intake was not possible or inadequate. The Dose will be repeated to ensure 3-4 loose motions per day. The Polyethylene Glycol group will get 17 gm of PEG (Polyethylene Glycol) administered orally or via nasogastric tube. PEG (Polyethylene Glycol)will be administered in 3-4 doses in 24 hours to ensure 3-4 loose stools per day.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented cirrhosis with any underlying etiology
- •Hepatic encephalopathy of grade II and above
- •18 to 65 years of age
排除标准
- •Acute change in mental status due to a diagnosis other than hepatic encephalopathy
- •Patients who have received lactulose as an anticoma measure before enrollment
- •Patient who have developed encephalopathy post bleed
- •Patients with gut paralysis
- •Patients with tense ascites
- •Patients with altered sensorium due to organic brain disease.
- •Patients with coexistent psychiatric illness that may hamper the proper assessment of hepatic encephalopathy
- •Hemodynamic instability obviating vasopressors for resuscitation
- •Acute liver failure defined as severe acute liver injury with encephalopathy and international normalized ratio (INR)≥1.5 in a patient without pre-existing liver disease
- •Refusal of consent
研究组 & 干预措施
Polyethlene Glycol
PEG (Polyethlene Glycol)- 17 gm sachet 3-4 times per day
干预措施: PEG- 17 gm sachet (Drug)
结局指标
主要结局
Complete reversal of hepatic encephalopathy in both groups.
时间窗: 3 days
Complete reversal is defined as Grade 0 Encephalopathy
次要结局
- Improvement in hepatic encephalopathy by two grades in both groups(3 days)
- Length of Intensive Care Unit stay in both groups(28 days)
- Adverse events in both groups(3 days)
- Presence of encephalopathy changes in Electroencephalography in both groups(3 days)