Angiotensin II in Liver Transplantation

What Was Tested

This registered phase 2, phase 3 trial tested Angiotensin II.

It had two arms (groups): Angiotensin II (Giapreza) (experimental) and Saline (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

This is a single center, randomized, double-blind, placebo-controlled trial.

Subjects will receive an infusion of either Angiotensin II (AngII) or a saline control (placebo) in addition to usual care with traditional vasopressors (catecholamines and vasopressin) during liver transplantation (LT).

AngII is a vasopressor approved by the FDA for the treatment of vasodilatory shock.

The study drug will be titrated throughout the case and discontinued at the end of surgery.

Who Took Part

50 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: Age \> or = 18 years. Liver transplantation from a deceased donor. Model for End-stage Liver Disease Sodium (MELD-Na) score \> or = 25 at the time of transplant (not counting MELD exception points).

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: living-donor liver transplantation (ldlt); split liver transplantation (isolated right or left lobe); acute liver failure (alf).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Angiotensin II, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-06-28 with completion listed for 2026-03-18.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 15 secondary outcomes, for example Proportion of patients requiring 3rd and 4th line vasopressor infusions (epinephrine or vasopressin) during LT, Time spent below target MAP (65 mmHg), Change in direct renin, Incidence of severe (stage 2 or 3) acute kidney injury (AKI) within 48 hours after LT, Major adverse kidney events (MAKE) at 30 days (MAKE-30) after LT and Incidence of early allograft dysfunction (EAD) by Olthoff criteria.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Angiotensin II in 50 people.

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

More context: the Angiotensin II compound page, all human trials.