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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
High volume plasma exchange sessions till a maximum of ten sessions.
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
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Transplant free survival
Time frame: 28 days
Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups
Time frame: Day 14
Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups
Time frame: Day 28
Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups
Time frame: Day 14
Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups
Time frame: Day 28
Improvement in APACHEII (by 2 points )
Time frame: 2 years
Improvement in MELD (by 2 points )
Time frame: 2 years
Improvement in SIRS by 2 points
Time frame: 2 years
Improvement in SOFA (by 2 points )
Time frame: 2 years
Incidence of new onset sepsis and SIRS in both groups.
Time frame: Day 28
Side effects of therapy in both groups
Time frame: 2 years
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