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

What Was Tested

This registered phase 2, phase 3 trial tested Terlipressin.

AVB is a well-recognized precipitant leading to the occurrence and development of ACLF.

It had two arms (groups): Bolus terlipressin (active comparator) and Continous Infusion of Terlipressin (experimental).

The registry classes the interventions as drug.

More on the Plan

Bolus terlipressin in the management of acute esophageal variceal bleeding in ACLF.

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.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients (age ≥ 18 years) diagnosed with ACLF presenting with due to esophageal varices bleeding.

The full record lists 1 inclusion and 9 exclusion criteria; among the exclusions: age \< 18 years; history of coronary heart disease or ventricular arrhythmia,; stroke or transient ischemic attack,.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Terlipressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Terlipressin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Terlipressin study: the participants and staff both knew the treatment.

It started in 2025-02-10 with completion listed for 2026-02-28.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 6 secondary outcomes, for example Failure to control hemostasis, Terlipressin-related complications within 5 days i.e. safety of the drug, Number of blood transfusions at 5 days, Rebleed within 42 day, Incidence of post-bleed Acute Kidney Injury within 5 days and 6 weeks mortality in both groups.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Terlipressin in 60 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Terlipressin compound page, all human trials.