Efficacy of Early Terlipressin Plus Albumin Therapy in Comparison to Standard Treatment for HRS-AKI in Acute-on-chronic Liver Failure.

What Was Tested

The trial (not phased) is built around Terlipressin.

These patients have severe hepatic dysfunction, and outcome is defined by functional hepatic reserve and extent of extra-hepatic organ failures(5).

Renal failure is a frequent extra-hepatic organ failure, and its presence is an independent prognostic marker for mortality(12).

It had two arms (groups): Terlipressin + Albumin (experimental) and Albumin (active comparator).

The registry classes the interventions as biological and drug.

More on the Plan

Aim To compare the effect of Early initiation of Terlipressin (ET arm) to albumin at 12 hour in ACLF patients with non-volume responsive AKI versus standard Terlipressin (ST arm) at 48 hours.

ACLF will be defined by the APASL criteria.

Study Design A prospective, randomized, single center open label study Study Period:Two year Intervention \& monitoring: Clinical Protocol An informed consent will be taken from ACLF patients with AKI within 24-hours of admission.

No alteration in the treatment or investigative procedures of the included patients will be done.

Who Took Part

70 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Age 18-65 years. ACLF as per APASL criteria. AKI at admission as defined by ICA-AKI criteria. AKI stage 2/3 at 12 hour of admission.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: age \<18 years; patients on renal replacement therapy (rrt); history of cad, ischemic cardiomyopathy, pvd, ventricular arrhythmia.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2020-06-22 with completion listed for 2022-06-10.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Acute Kidney Injury reversal by day 7 in both groups (time frame: Day 7).

It also tracked 4 secondary outcomes, for example Mortality in both groups, Mortality in both groups, Progression or resolution of Organ failures and Adverse Events in both groups.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Terlipressin in 70 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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