Angiotensin 2 for AKI After OLT

What Was Tested

In this phase 4 trial, researchers set out to test Angiotensin II.

The researchers propose to investigate how early administration of Ang 2, a new vasopressor drug approved by the FDA in December 2017 for patients with low blood pressure, during the intra-operative period of liver transplant surgery affects the rate of kidney injury after transplantation.

It had two arms (groups): Intervention (experimental) and Control (active comparator).

Patients assigned to the control group will undergo intraoperative management with a standard vasopressor regimen composed of norepinephrine, vasopressin and epinephrine based on hemodynamic goals established by the surgical and anesthesia teams prior to surgery.

The registry classes the interventions as drug.

More on the Plan

Angiotensin 2 was approved for clinical use as a vasopressor in 2017.

As vasodilatory shock is common among patients undergoing LT, this finding is relevant to their patient population.

Hypothesis: the researchers propose that a relative deficiency of angiotensin 2 predisposes cirrhotic patients to develop acute kidney injury following liver transplantation.

Rates of recovery from AKI in patients with septic shock have been established in post-hoc analysis of the ATHOS-3 study.

Who Took Part

The registry lists 30 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.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Everyone knew when Angiotensin II was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-04-08 with completion listed for 2026-12.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Incidence of Acute kidney Injury (time frame: Every day for 14 days following intervention).

It also tracked 5 secondary outcomes, for example Need for Renal Replacement therapies, In hospital mortalituy, Urine output and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Angiotensin II in 30 people.

Its size is small, so on its own it can only give an early look.

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.