A Randomized Controlled Trial of Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Transplant free survival in all the group
研究概览
简要总结
The study is done with the aim of finding the association between the bilirubin and bile acids / DAMPS molecule with organ failures and sepsis in the patients with acute on chronic liver failure . in this study there are 2 parts in the first part people who satisfy the eligibility criteria will be recruited and blood samples will be taken and above mentioned molecules will be analyzed and association ,if any with occurrences of organ failures / new onset sepsis will be analyzed .
In the second part of the study the patients who meet the criteria will be randomized to either receive standard medical therapy or with either haemoperfusion or therapeutic plasma exchange with standard medical therapy . blood samples will be taken and stored, bile acids (primary and secondary bile acids, bilirubin and damps molecules will be analysed .the patients are followed for 90 days , then statistical analysis will be done to find the association with organ failures and new onset sepsis .
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
- •Patients diagnosed with ACLF as per APASL criteria will be included.
- •Age : 18-65 yrs.
排除标准
- •Patient with ischemic heart disease
- •Patient with chronic obstructive disease.
- •Patient with hepato cellular carcinoma.
- •Patient with extra hepatic malignancy.
- •Patient with chronic renal insufficiency.
研究组 & 干预措施
Standard Medical Treatment
Group A will be given standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.
干预措施: Standard Medical Treatment (Drug)
Hemoadsorption plus standard medical therapy
干预措施: Haemoperfusion (Drug)
Hemoadsorption plus standard medical therapy
干预措施: Standard Medical Treatment (Drug)
Plasma Exchange plus standard medical therapy
干预措施: Standard Medical Treatment (Drug)
Plasma Exchange plus standard medical therapy
干预措施: Plasma Exchange (Other)
结局指标
主要结局
Transplant free survival in all the group
时间窗: day 28
次要结局
- New onset of sepsis in ll the groups(Day 28)
- Development of organ dysfunction in all the group(Day 28)
- Adverse Events in all the groups(Day 28)