Overview

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

Status:
Not yet recruiting
Trial end date:
2024-06-30
Target enrollment:
0
Participant gender:
All
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 Phase: N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Treatments:
Carvedilol
Criteria
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