To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF).
Not Applicable
Withdrawn
- Conditions
- Acute-On-Chronic Liver Failure
- Interventions
- Drug: Standard Medical TherapyBiological: Plasma ExchangeBiological: GCSF
- Registration Number
- NCT03162419
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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.
Exclusion Criteria
- Steroid eligible patients with severe alcoholic hepatitis
- Cirrhosis of liver with previous history of decompensation
- Patients with severe cardiopulmonary disease
- Pregnancy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Medical Therapy 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. Standard Medical Therapy + Plasma exchange + GCSF Standard Medical Therapy 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. Standard Medical Therapy + Plasma exchange + GCSF Plasma Exchange 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. Standard Medical Therapy + Plasma exchange + GCSF 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. Standard Medical Therapy + GCSF Standard Medical Therapy 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 Standard Medical Therapy + GCSF 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
- Primary Outcome Measures
Name Time Method Transplant free survival 28 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Institute of Liver and Biliary Sciences
🇮🇳New Delhi, Delhi, India