To Study the Hemodynamic Response of Early Addition of Carvedilol to Terlipressin in Acute Variceal Bleed in Child's B and C Cirrhosis

NCT05699824 | Unknown

• 1 other identifier: ILBS-Cirrhosis-53
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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 \</= 12 mmHg for secondary prophylaxis for prevention of rebleeding. Studies have shown the safety of giving terlipressin in patients receiving beta- blockers. We aim to achieve hemodynamic response with addition of carvedilol with vasoactive agent for reduction of portal blood flow to decreases rebleeding episodes and reduce mortality.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Hemodynamic response in both groups

  Hemodynamic response (HVPG reduction of ≥20% from baseline or absolute reduction of HVPG \</= 12 mmHg) in the groups at 5-days.

  Day 5

Secondary Outcomes (5)

• Rebleeding within 6-week in both groups

  6-weeks

• Death in both groups

  6-weeks

• Adverse Effects in both groups

  6 weeks

• Decompensation events (ascites) at 6-weeks in both groups

  6 weeks

• Decompensation events (Hepatic Encephalopathy) at 6-weeks in both groups

  6 weeks

Study Arms (2)

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

Drug: Carvedilol Day2; Other: Standard Medical Treatment

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

Other: Standard Medical Treatment; Drug: Carvedilol Day6

Interventions

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.

Carvedilol at Day2 + Standard Medical Treatment

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 at Day2 + Standard Medical Treatment; Carvedilol at Day6 + 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.

Carvedilol at Day6 + Standard Medical Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhosis with Acute Variceal Bleed
• Child's B and C cirrhosis (CTP ≤ 12)
• Patients age between 18 to 75 years

You may not qualify if:

• Gastric variceal bleed
• Bleeding related to coagulopathy
• Other causes of portal hypertensive bleeding
• Acute on chronic liver failure
• Sepsis
• Shock(persistence of hypotension)
• Acute kidney injury (\>1.5 mg%)
• Grade 3 Ascites
• Hyponatremia (Na \< 125 mEq/L)
• Complete portal vein thrombosis
• Hepatocellular carcinoma (\>3cm lesion)
• Tumoral portal vein thrombosis
• Chronic kidney disease
• Coronary artery disease
• Valvular heart disease

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr Ibrar Ahmed, MD

CONTACT

01146300000; ibrarkhangmc29@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 26, 2023
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 1, 2023

Record last verified: 2022-12

Locations

IN (1)