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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05699824
• Other study ID #: ILBS-Cirrhosis-53
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2022
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Ibrar Ahmed, MD
• Phone: 01146300000
• Email: ibrarkhangmc29[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Cirrhosis with Acute Variceal Bleed

• Child's B and C cirrhosis (CTP = 12)

• Patients age between 18 to 75 years

Exclusion Criteria:

• 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

• Sick sinus syndrome/ Pacemaker

• Arrythmia

• Uncontrolled hypothyroidism and hyperthyroidism

• Pregnancy

• Failure to give consent

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• Carvedilol Day2
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.

Other:
• Standard Medical Treatment
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

Drug:
• Carvedilol Day6
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.

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic response in both groups	Hemodynamic response (HVPG reduction of =20% from baseline or absolute reduction of HVPG	Day 5
Secondary	Rebleeding within 6-week in both groups		6-weeks
Secondary	Death in both groups		6-weeks
Secondary	Adverse Effects in both groups		6 weeks
Secondary	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
Secondary	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