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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Medical Therapy | Active Comparator | 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 | Experimental | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Medical Therapy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant free survival | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups | Day 14 | |
| Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups | Day 28 |
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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:
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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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| Plasma Exchange | Biological | High volume plasma exchange sessions till a maximum of ten sessions. |
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| GCSF | 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 |
|
| Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups | Day 14 |
| Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups | Day 28 |
| Improvement in APACHEII (by 2 points ) | 2 years |
| Improvement in MELD (by 2 points ) | 2 years |
| Improvement in SIRS by 2 points | 2 years |
| Improvement in SOFA (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 |
| 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 |
|---|---|
| D010951 | Plasma Exchange |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
| D001781 | Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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