Efficacy of Lactulose Plus Intravenous Branched Chain Amino Acids Versus Lactulose Alone in Patients of Acute on Chronic Liver Failure With Overt Hepatic Encephalopathy: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Improvement of Survival
研究概览
简要总结
This study analyses the effect of intravenous branched chain amino acids (BCAA) on overt HE in patients with ACLF. The investigators plan to study the efficacy of combining intravenous BCAA with lactulose versus lactulose alone in the medical management of overt HE in patients with ACLF and its impact on overall survival and improvement in grade of HE.
详细描述
Acute on chronic liver failure (ACLF) is a distinct clinical entity in the spectrum of chronic liver disease associated with high short term mortality. Hepatic encephalopathy (HE) is commonly seen in patients with ACLF and its treatment mainly involves non-absorbable disaccharides (lactulose/lactitol).Treatment of HE in ACLF is based on extrapolation of data available from cirrhotic patients. No studies have compared different treatment options for HE in patients with ACLF.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Either gender
- •Patients with ACLF (CANONIC definition) of any aetiology with HE ≥grade 2 as per West-Haven Criteria or Hepatic encephalopathy scoring algorithm (HESA)
排除标准
- •Those who do not consent to participate in the study
- •Patients with structural brain lesions or stroke
- •Inability to obtain informed consent from patient or relatives
- •Severe preexisting cardiopulmonary disease
- •Renal dysfunction (S. Creatinine ≥ 2mg/dL)
- •Pregnancy/Lactation
- •Post liver transplant patients
- •HIV infection
- •Patients who are on psychoactive drugs, like sedatives or antidepressants
- •Patients who are too sick to carry out the protocol
- •As the study was carried out during the peak of the COVID-19, patients who developed COVID-19 after randomization were excluded from the analysis as they were shifted to dedicated COVID-19 ICU's.
研究组 & 干预措施
IV BCAA + Lactulose
IV Branched Chain Amino Acids - 500mL once daily for 3 days plus Lactulose
干预措施: Branched chain amino acid (Drug)
IV BCAA + Lactulose
IV Branched Chain Amino Acids - 500mL once daily for 3 days plus Lactulose
干预措施: Lactulose (Drug)
Lactulose alone
Oral Lactulose alone
干预措施: Lactulose (Drug)
结局指标
主要结局
Improvement of Survival
时间窗: At day day 28
All cause Mortality assessment
Improvement of encephalopathy by ≥ 1 grade
时间窗: 72 hours
Improvement in hepatic encephalopathy
次要结局
- Reduction in level of ammonia(48 and 72 hours)
- Reduction of consciousness recovery time among survivors(30 days)
- Prolongation of time to death among non-survivors(30 days)
- Prevention/reduction of cerebral edema based on optic nerve sheath diameter(72 hours)
研究者
Madhumita Premkumar
Assistant Professor
Post Graduate Institute of Medical Education and Research, Chandigarh