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

Phase 2

Not yet recruiting

• Conditions: Acute on Chronic Liver Failure
• Interventions: Drug: Terlipressin Injectable Product

• Registration Number: NCT06815770
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Aim and Objective - To assess the safety and efficacy of continuous terlipressin vs. Bolus terlipressin in the management of acute esophageal variceal bleeding in ACLF.

Study population: Adult patients (age ≥ 18 years) diagnosed with ACLF presenting with upper GI bleeding due to esophageal varices Study design: Pilot study Study period: 1 year Sample size: 60

Intervention:

Group I- Intravenous terlipressin (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.

Group II- Intravenous terlipressin (2 mg initially every 4 hourly for 2 days and then 1 mg every 4 hrs)

Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will receive either steroid or plasma exchange followed by steroid

Adverse effects:

Acute Diarrhea, chest pain, Arterial hypertension, Cardiac arrhythmias, Acute abdomen Stopping rule: chest pain, alteration of ECG, cyanosis, bradycardia, severe allergic rashes

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Study Start: 2025-02-10
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bolus terlipressin	Terlipressin Injectable Product	2 mg initially every 4 hourly for 2 days and then 1 mg every 4 hrs.
Continous Infusion of Terlipressin	Terlipressin Injectable Product	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
6 weeks mortality in both groups.	6 weeks

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences (ILBS); 🇮🇳 New Delhi, Delhi, India