High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit-A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Resolution in Hepatic Encephalopathy by 2 grades in both groups
研究概览
简要总结
Study Design- Randomized Controlled trial Duration of enrolment-Feb-2016 to December 2017 Sample size-120 patients Methodology We will include consecutive with advanced hepatic encephalopathy not responding to treatment of precipitants and on treatment with Lactulose and Rifaximin for 48 hours .
Two groups will be divided. One arm -Lactulose and Rifaximin will be continued Second Arm - Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days)
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotics
- •Age between 18-70 years
- •Hepatic encephalopathy -Grade 3-4
- •Patients receiving Lactulose/Rifaximin for 48 hours and not showing improvement in Hepatic encephalopathy(Persistent Grade 3/4)
排除标准
- •Concomitant participation in an other clinical trial
- •Patient receiving sedatives(propofol,etc) 24 hours prior.
- •Patients with severe cardiopulmonary disease
- •Pregnancy
- •Human Immunodeficiency Virus
- •Hepatocellular Carcinoma or extrahepatic malignancy
- •Active uncontrolled sepsis with hemodynamic instability
- •Chronic renal insufficiency on treatment with haemodialysis
- •Uncontrolled bleed or patients in DIC
- •Extremely moribund patients with expected survival of less than 48 hours on high vasopressor support
- •Patients with moderate-severe Acute Respiratory Distress Syndrome (ARDS).
- •Patients with Non Hepatic Coma.
研究组 & 干预措施
Lactulose with Rifaximin
干预措施: Lactulose (Drug)
Lactulose with Rifaximin
干预措施: Rifaximin (Drug)
Plasmapheresis
Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days)
干预措施: Plasmapheresis (Biological)
结局指标
主要结局
Resolution in Hepatic Encephalopathy by 2 grades in both groups
时间窗: Day 5
次要结局
- Survival in both groups(28 days)
- Number of days of mechanical ventilation in both groups(2 years)
- Improvement in Hepatic Encephalopathy in both groups(2 years)
- Proportion of patients with failure of standard medical therapy in both groups.(48 hours)
- Proportion of patients with Systemic inflammatory response syndrome (SIRS) or sepsis as precipitants of Hepatic encephalopathy in both groups.(2 years)