Secondary Prophylaxis of hepatic encephalopathy in cirrhosis:A double Blind randomized controlled trial of L-Ornithine L-Aspartate (LOLA) versus placebo
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- •Superiority of L-Ornithine L-Aspartate compared to placebo in the efficacy of prevention of overt HE recurrence.
研究概览
简要总结
Hepatic encephalopathy is aneuropsychiatric disorder caused by central nervous system effect of the toxinsthat accumulate in the blood because of the inability of liver to perform itsnormal detoxification functions. Treatment of HE cost alot to the hospital andhas got a high mortality rate. Gut-derived nitrogenous substances areuniversally acknowledged to play a major role in the pathogenesis of hepaticencephalopathy. Ammonia- induced alterationsin cerebral blood flow and glucose metabolism have shown that there is asignificant decrease of glucose utilization of various cortical regions thatcorrelate with the patients cognitive functions. L-Ornithine L-Aspartate (LOLA) act by reducing blood ammonia leveland reducing symptoms in patients of HE. But data regarding it’s use inprophylaxis of HE is scarce. We hypothesise that L -Ornithine L-Aspartate (LOLA) by reducingblood ammonia level in cirrhotics may be useful in secondary prophylaxis ofhepatic encephalopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Liver cirrhosis (Child B or Child C class) •History of recovery from episod of overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months.
- •â€¢No evidence of overt hepatic encephalopathy at the time of enrollment.
排除标准
- •â€¢History of taking lactulose, rifaximin, neomycin, metronidazole, HepaMerz or probiotics in past 6 weeks •Alcohol intake during past 6 weeks •Receiving secondary prophylaxis for spontaneous bacterial peritonitis •Previous transjugular intrahepatic portosystemic shunts or shunt surgery •Significant comorbid illness such as heart, respiratory or kidney failure, and neurological disease such as Alzheimer’s disease, Parkinson’s disease and non hepatic metabolic encephalopathies •Receiving psychoactive drugs such as antidepressants and sedatives •Foreseeable risk of alcohol consumption during the study conduct.
- •â€¢Hepatocellular carcinoma •Anemia (Hemoglobin <8gm/dL) •Electrolyte abnormality (Serum sodium <125meq/L or serum potassium <2.5meq/L) •Intercurrent infection such as spontaneous bacterial peritonitis •Pregnancy, breast feeding or refusal to use a contraceptive method in women of child bearing age •Patients with foreseeable compliance <80% during study conduct monitored by counting sachets of Hepa-Merz and bottles of lactulose consumed every month.
结局指标
主要结局
•Superiority of L-Ornithine L-Aspartate compared to placebo in the efficacy of prevention of overt HE recurrence.
时间窗: one week to 3 months
次要结局
- •Time taken for first breakthrough episode of overt hepatic encephalopathy(•Time to first overt hepatic encephalopathy-related hospital admission)