Status
Withdrawn
Phase
Not applicable
Enrollment
0
Locations
1
Results
Not posted
Publications
0
Study 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
Interventions
DRUG
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.
BIOLOGICAL
High volume plasma exchange sessions till a maximum of ten sessions.
BIOLOGICAL
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
Timeline
First posted
May 22, 2017
Study start
May 1, 2017
Primary completion
Apr 25, 2019
Study completion
Apr 25, 2019
Results posted
Not reported
Registry updated
Dec 3, 2018
Outcomes
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
Eligibility
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: 1. Steroid eligible patients with severe alcoholic hepatitis 2. Cirrhosis of liver with previous history of decompensation 3. Patients with severe cardiopulmonary disease 4. Pregnancy 5. Human Immmunodeficiency Virus infection 6. Hepatocellular carcinoma or extrahepatic malignancy 7. Chronic renal insufficiency on treatment with haemodialysis 8. Uncontrolled bleed or patients in disseminated intravascular coagulopathy 9. Patient with expected survival of less than 48 hours 10. Patients with moderate-severe acute respiratory distress syndrome 11. Hemodynamic instability with noradrenaline requirement of more than \>0.5ug/kg/min or requirement of dual vasopressors 12. Patients with leukemoid reaction or total leucocyte count \> 40,000/mm3 13. Patients diagnosed with Hemophagocytic Lymphohistiocytosis 14. Patients with known hypersensitivity to Granulocyte colony stimulating factor
Study locations
India. Showing up to 24 locations stored in the fast local snapshot.
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Publications
No PMID-linked publications were present in this registry snapshot.
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