Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving Outcomes of Acute Kidney Injury in Acute on Chronic Liver Failure With Septic Shock

What Was Tested

The trial (not phased) is built around Terlipressin.

However, this initial rise is short lasting, and the vasopressin levels come back to normal or low serum levels with continued hypotension.

It had two arms (groups): Continuous terlipressin infusion + Norepinephrine (experimental) and Norepinephrine (active comparator).

The registry classes the interventions as drug.

More on the Plan

Study population: 1. septic shock with AKI in patients of ACLF Study design: Prospective open labelled randomised controlled study.

The study will be conducted in Department of Hepatology ILBS- intensive care unit.

Daily. • Others - daily chest X-ray, Procalcitonin, Cardiac-ECG, 2D echo.

Who Took Part

The registry lists 126 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Age\>18 years and \<60 yrs. ACLF as per APASL. AKI according to KDIGO Criteria.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: symptomatic cardiopulmonary disease; chronic kidney disease; peripheral vascular disease.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Terlipressin and who got the comparison, which limits bias.

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

Being open-label, the Terlipressin study did not mask who received what.

It started in 2024-08-15 with completion listed for 2025-08-31.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Outcome of acute kidney injury at day 4,7, Incidence of adverse events in both groups, Need of renal replacement therapy at day 7, Duration of ICU and hospital stay and Mortality.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Terlipressin in 126 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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