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

NCT06815770 | Not Yet Recruiting Phase 2

• 1 other identifier: ILBS-ACLF-22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute on Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

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

  12-24 hours

Secondary Outcomes (6)

• Failure to control hemostasis

  5 days

• Terlipressin-related complications within 5 days i.e. safety of the drug

  5 days

• Number of blood transfusions at 5 days

  5 days

• Rebleed within 42 day

  42 days

• Incidence of post-bleed Acute Kidney Injury within 5 days

  5 days

Study Arms (2)

Bolus terlipressin

ACTIVE COMPARATOR

2 mg initially every 4 hourly for 2 days and then 1 mg every 4 hrs.

Drug: Terlipressin Injectable Product

Continous Infusion of Terlipressin

EXPERIMENTAL

Administered as a continuous infusion at 4 mg/24 hours. After 12 hours, if the hepatic venous pressure gradient (HVPG) does not show a reduction of less than 10%, increase the dose to 6 mg/24 hours.

Drug: Terlipressin Injectable Product

Interventions

Terlipressin Injectable Product DRUG

Terlipressin Injectable Product

Bolus terlipressin; Continous Infusion of Terlipressin

Eligibility Criteria

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

You may qualify if:

• Adult patients (age ≥ 18 years) diagnosed with ACLF presenting with due to esophageal varices bleeding.

You may not qualify if:

• Age \< 18 years
• History of coronary heart disease or ventricular arrhythmia,
• Stroke or transient ischemic attack,
• Bronchial asthma,
• Epilepsy,
• Pregnancy,
• Rebleeding.
• HCC
• Gastric variceal bleed

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

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

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Central Study Contacts

Dr Khushboo Yadav, MD

CONTACT

01146300000; ky29277@gmail.com

Dr Vinod S Arora, DM

CONTACT

01146300000; VINOD_UCMS@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 7, 2025
• Study Start: February 10, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-01

Locations

IN (1)