Efficacy and Safety of Continuous Infusion of Terlipressin vs Bolus Terlipressin in ACLF Patients With Acute Esophageal Variceal Bleed

NCT06815770 · tracked via the Priya Life Science India tracker

Sponsor

Institute of Liver and Biliary Sciences, India

Phase

Phase 2/3

Started

2025-02-10

Last updated

2025-02-07

Condition(s) studied

Acute on Chronic Liver Failure

Investigational drug(s) / intervention(s)

Terlipressin Injectable Product

Terlipressin Injectable Product: Terlipressin Injectable Product

Study summary

Acute portal hypertension, as measured by rapid rise in hepatic venous pressure gradient (HVPG) can lead to further dreaded complications, including acute variceal bleeding (AVB) AVB: 6-week mortality rates of around 15-20% in patients with chronic liver disease without ACLF.The overall prevalence of UGH in cirrhotic patients with AD was 34.4% and 35.7% in patients with ACLF.AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. Medical therapy for esophageal variceal bleeding (EVB) aims to reduce the splanchnic blood flow and portal pressure. The most common vasoactive agents include terlipressin, vasopressin, somatostatin, and octreotide.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Adult patients (age ≥ 18 years) diagnosed with ACLF presenting with due to esophageal varices bleeding. Exclusion Criteria: 1. Age \< 18 years 2. History of coronary heart disease or ventricular arrhythmia, 3. Stroke or transient ischemic attack, 4. Bronchial asthma, 5. Epilepsy, 6. Pregnancy, 7. Rebleeding. 8. HCC 9. Gastric variceal bleed

Primary outcome measure(s)

Hepatic venous Pressure Gradient (HVPG) reduction of more than 10% from baseline at 12-24 hours in both arms. — 12-24 hours

Trial sites (1)

Facility	City	Region	Status
Institute of Liver & Biliary Sciences (ILBS)	New Delhi	National Capital Territory of Delhi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06815770 on ClinicalTrials.gov ↗ ← All trials in India