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Management of Acute variceal bleeding includes endoscopic variceal ligation (EVL) along with vasoactive agents. Inspite of successful hemostasis, this is associated with high variceal rebleeding (VRB) in Child B and C cirrhosis and have higher 6-week mortality rates. Pre-emptive TIPS has shown to prevent rebleed and improve survival in child B and C patients but is associated with liver related complications in advanced disease. HVPG guided therapy and treatment response is known to improve rebleeding and associated with improved survival. This is based on achieving hemodynamic response defined as HVPG reduction of ≥20% from baseline or absolute reduction of HVPG \
Aim and Objective To compare the hemodynamic response of early addition of carvedilol with terlipressin in patients with cirrhosis presenting with acute esophageal variceal bleeding.
Primary objective • To study the hemodynamic response (HVPG reduction of ≥20% from baseline or absolute reduction of HVPG \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol at Day2 + Standard Medical Treatment | Experimental | Arm A- Carvedilol will be initiated on day 2, at a dose of 3.125mg twice a day (6.25mg/day), along with standard management as per institutional protocol for AVB. All patients to receive Inj. Terlipressin, 1 mg at 4 hours along with standard management for acute variceal bleed as per institutional protocol |
|
| Carvedilol at Day6 + Standard Medical Treatment | Active Comparator | Arm B- Carvedilol will be initiated on day 6, at a dose of 3.125mg twice a day (6.25mg/day), along with standard management as per institutional protocol for AVB. All patients to receive Inj. Terlipressin, 1 mg at 4 hours along with standard management for acute variceal bleed as per institutional protocol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol Day2 | Drug | Carvedilol will be initiated on day 2, at a dose of 3.125mg twice a day (6.25mg/day), along with standard management as per institutional protocol for AVB. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic response in both groups | Hemodynamic response (HVPG reduction of ≥20% from baseline or absolute reduction of HVPG \ | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Rebleeding within 6-week in both groups | 6-weeks | |
| Death in both groups | 6-weeks | |
| Adverse Effects in both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Ibrar Ahmed, MD | Contact | 01146300000 | ibrarkhangmc29@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Standard Medical Treatment | Other | All patients to receive Inj. Terlipressin, 1 mg at 4 hours along with standard management for acute variceal bleed as per institutional protocol. Standard Medical Treatment |
|
| Carvedilol Day6 | Drug | Carvedilol will be initiated on day 6, at a dose of 3.125mg twice a day (6.25mg/day), along with standard management as per institutional protocol for AVB. |
|
| 6 weeks |
| Decompensation events (ascites) at 6-weeks in both groups | Ascites defined as either development of ascites during the follow-up or worsening of pre-existing ascites either in the form of increasing the dose requirement of diuretic or requirement of therapeutic paracentesis. | 6 weeks |
| Decompensation events (Hepatic Encephalopathy) at 6-weeks in both groups | New onset of Hepatic Encephalopathy. Hepatic encephalopathy is defined based on clinical parameters as per the West-Haven criteria. | 6 weeks |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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