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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peg GCSF with standard medical therapy | Experimental |
| |
| Placebo with standard medical therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peg GCSF | Drug |
| ||
| 20% Albumin |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant free survival in both groups | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative assessment of CD34 positive cells in serum in both groups. | On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done | 1 year |
| Quantitative assessment of CD34 positive cells in liver biopsy samples in both groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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|
| Nutrition | Dietary Supplement |
|
| Bowel wash | Other |
|
| Terlipressin 1- 4mg,if indicated | Drug |
|
| Meropenem or Imepenem, if indicated | Drug |
|
| Placebo | Drug |
|
On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done |
| 1 year |
| 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 |
| Development of new onset complications such as Hepatocellular carcinoma (HCC). | 1 year |
| 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 |
| ID | Term |
|---|---|
| D065290 | Acute-On-Chronic Liver Failure |
| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| D009752 | Nutritional Status |
| D000077585 | Terlipressin |
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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