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Group A - Subjects will receive Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) Group B - Midodrine 7.5 mg TDS x 3 days Group C - Standard medical therapy only
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terlipressin | Experimental | Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) |
|
| Midodrine | Active Comparator | Midodrine 7.5 mg thrice daily for 3 days. |
|
| Standard Medical Therapy | Active Comparator | Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terlipressin | Drug | Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Paracentesis Induced Circulatory Dysfunction (PICD). | Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hospital admission withing 28 days in all the 3 groups | 28 days | |
| Development of Hyponatremia in all the 3 groups | Hyponatremia is defined as S.Na < 130 meq/dL. | Day 28 |
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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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| Midodrine | Drug | Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) |
|
| Albumin | Drug | Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping. |
|
| Development of Hepatic Encephalopathy in all the 3 groups | Hepatic Encephalopathy defined as West Haven Grade > 1 | Day 28 |
| Recurrence of ascites in all the 3 groups | Day 28 |
| Development of Acute Kidney Injury in all the 3 groups | Acute Kidney Injury is defined as increase S.Creatinine by more than 0.3 mg/dL | Day 28 |
| Survival in all the 3 groups | Day 28 |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077585 | Terlipressin |
| D008879 | Midodrine |
| D000418 | Albumins |
| ID | Term |
|---|---|
| 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 |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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