To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF)-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
- Transplant free survival
研究概览
简要总结
Study design-Open label randomized controlled trial
Study period-2 years
Study population-All patients of ACLF admitted to ILBS for a period of two years from Feb 2017 to Dec 2018
All the patients of ACLF will receive standard medical therapy and will be randomized within 48 hours of admission into three groups after screening for exclusion and inclusion criteria.(1:2:2) Group A-Standard Medical Therapy only Group B-Standard Medical therapy + Plasma exchange + GCSF Group C-Standard Medical Therapy + GCSF
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
- •All consecutive patients in age group of 18-70 years with acute on chronic liver failure as defined by APASL criteria shall be included in the study.Only those patients who wish to be enrolled in the trial shall be included in the study.
排除标准
- •Steroid eligible patients with severe alcoholic hepatitis
- •Cirrhosis of liver with previous history of decompensation
- •Patients with severe cardiopulmonary disease
- •Human Immmunodeficiency Virus infection
- •Hepatocellular carcinoma or extrahepatic malignancy
- •Chronic renal insufficiency on treatment with haemodialysis
- •Uncontrolled bleed or patients in disseminated intravascular coagulopathy
- •Patient with expected survival of less than 48 hours
- •Patients with moderate-severe acute respiratory distress syndrome
- •Hemodynamic instability with noradrenaline requirement of more than >0.5ug/kg/min or requirement of dual vasopressors
- •Patients with leukemoid reaction or total leucocyte count > 40,000/mm3
- •Patients diagnosed with Hemophagocytic Lymphohistiocytosis
- •Patients with known hypersensitivity to Granulocyte colony stimulating factor
研究组 & 干预措施
Standard Medical Therapy
The patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.
干预措施: Standard Medical Therapy (Drug)
Standard Medical Therapy + Plasma exchange + GCSF
The patients in group B shall be given GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28 along with alternate day high volume plasma exchange sessions till a maximum of ten sessions.
干预措施: Standard Medical Therapy (Drug)
Standard Medical Therapy + Plasma exchange + GCSF
The patients in group B shall be given GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28 along with alternate day high volume plasma exchange sessions till a maximum of ten sessions.
干预措施: Plasma Exchange (Biological)
Standard Medical Therapy + Plasma exchange + GCSF
The patients in group B shall be given GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28 along with alternate day high volume plasma exchange sessions till a maximum of ten sessions.
干预措施: GCSF (Biological)
Standard Medical Therapy + GCSF
The patients in this will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.
The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28
干预措施: Standard Medical Therapy (Drug)
Standard Medical Therapy + GCSF
The patients in this will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.
The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28
干预措施: GCSF (Biological)
结局指标
主要结局
Transplant free survival
时间窗: 28 days
次要结局
- Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups(Day 28)
- Improvement in SOFA (by 2 points )(2 years)
- Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups(Day 28)
- Improvement in SIRS by 2 points(2 years)
- Improvement in APACHEII (by 2 points )(2 years)
- Improvement in MELD (by 2 points )(2 years)
- Incidence of new onset sepsis and SIRS in both groups.(Day 28)
- Side effects of therapy in both groups(2 years)