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Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) ≥ 12 mmHg + No/small esophageal varices who present to the Department of Hepatology at Institute of Liver and Billiary Sciences, who meet the inclusion criteria and who provide informed consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol | Experimental | Tab Carvedilol 3.125 mg twice daily followed by 6.25 mg BD and finally 12.5 mg BD if SBP > 90 mmHg and HR >55/min |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality in both groups | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with development or progression of esophageal varices in both groups. | 3 Months | |
| Number of patients with reduction in hepatic venous pressure gradient (HVPG) in both groups. | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Sumeet Kainth, MD | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31541422 | Derived | Kumar M, Kainth S, Choudhury A, Maiwall R, Mitra LG, Saluja V, Agarwal PM, Shasthry SM, Jindal A, Bhardwaj A, Kumar G, Sarin SK. Treatment with carvedilol improves survival of patients with acute-on-chronic liver failure: a randomized controlled trial. Hepatol Int. 2019 Nov;13(6):800-813. doi: 10.1007/s12072-019-09986-9. Epub 2019 Sep 20. |
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| ID | Term |
|---|---|
| D065290 | Acute-On-Chronic Liver Failure |
| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Number of patients with regression in esophageal varices in both groups. | 3 Months |
| Number of patients with improvement in Liver severity scores in both groups. | 28 days |
| Number of patients with improvement in Liver severity scores in both groups. | 60 days |
| Number of patients with improvement in Liver severity scores in both groups. | 3 months |
| Number of patients with development of adverse events in both groups in both groups. | 28 days |
| Number of patients with development of adverse events in both groups in both groups. | 2 months |
| Number of patients with development of adverse events in both groups in both groups. | 3 Months |
| Number of patients who will develop esophageal variceal bleeding in both groups | 28 days |
| Number of patients who will develop esophageal variceal bleeding in both groups | 2 Months |
| Number of patients who will develop esophageal variceal bleeding in both groups | 3 Months |
| Development of complications in both groups | AKI,Pneumonia,SBP and other infections | 28 days |
| Development of complications in both groups | AKI,Pneumonia,SBP and other infections | 2 months |
| Development of complications in both groups | AKI,Pneumonia,SBP and other infections | 3 months |
| Mortality in both groups | 2 months |
| Mortality in both groups | 3 months |
| D004066 |
| Digestive System Diseases |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |