Acute on Chronic Liver Failure
Conditions
Brief summary
All consecutive ACLF (Acute on Chronic Liver failure) patients presenting to the institute of liver and biliary sciences, irrespective of the etiology , who have survived the acute phase (i.e. 90 days of onset of the acute on chronic liver failure) and who are willing to participate in the study would be enrolled. After performing baseline biochemical tests, patients will undergo transjugular liver biopsy (TJLB), HVPG (Hepatic Venous Pressure Gradient), Circulating CD34 cells, Bone marrow aspiration and biopsy (Histopathological and immunohistochemical examination will be done).
Interventions
DRUGPeg GCSF
BIOLOGICAL20% Albumin
DIETARY_SUPPLEMENTNutrition
OTHERBowel wash
DRUGTerlipressin 1- 4mg,if indicated
DRUGMeropenem or Imepenem, if indicated
DRUGPlacebo
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects aged 18-65 years * All patients who were known to have ACLF and have survived 3 months of the onset of acute event * Patients willing to participate in the study
Exclusion criteria
* Presence of AKI (Acute Kidney Injury) * Active sepsis (Blood/ urine culture positive, SBP (Spontaneous bacterial Peritonitis, LRTI (lower Respiratory Tract infection) * Sickle cell anemia * HepatoCellular Carcinoma * Hematological malignancies * Multi organ failure * Grade 3/ 4 HE (Hepatic Encephalopathy) * HIV seropositivity * Pregnancy * Patients being taken up for transplant * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transplant free survival in both groups | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative assessment of CD34 positive cells in liver biopsy samples in both groups. | 1 year | On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done |
| Reduction in liver disease severity indices like CTP (Child-Turcotte-Pugh) by more than one point in both groups. | 1 year | — |
| Reduction in liver disease severity indices like MELD Na ((Model for End Stage liver disease) by more than 2 points in both groups. | 1 year | — |
| Development of new onset complications such as hepatic encephalopathy in both groups. | 1 year | — |
| Development of new onset complications such as hepatorenal syndrome in both groups. | 1 year | — |
| Development of new onset complications such as sepsis in both groups. | 1 year | — |
| Quantitative assessment of CD34 positive cells in serum in both groups. | 1 year | On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done |
| Total number of CD34 positive cells in histopathological examination of bone marrow in both groups | 1 year | — |
| No of adverse events in both groups | 1 year | — |
| Reduction in HVPG (Hepatic Venous Pressure Gradient) in both groups | 1 year | — |
| Reduction in HBV DNA level in both groups. | 1 year | — |
| Number of patients who will restart alcohol abuse during the follow up period in both groups. | 1 year | — |
| Development of new onset complications such as Hepatocellular carcinoma (HCC). | 1 year | — |
Countries
India
Outcome results
None listed