Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin II

What Was Tested

The trial (phase 3) is built around Angiotensin II.

The intervention aims to address this gap by evaluating angiotensin II's impact compared to norepinephrine.

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

Intravenous infusion through a central line according to the patient's situation. Target medium arterial pressure (MAP): \>65mmHg.

Intravenous infusion through a central line according to the patient's situation. Target medium arterial pressure (MAP): \>65mmHg.

The registry classes the interventions as drug.

More on the Plan

In the context of cardiac surgery with the use of the cardiopulmonary bypass (CPB), sympathetic nervous system activation and cardiovascular instability are common sequelae.

Currently, norepinephrine is the established first-line vasopressor for the treatment of vasoplegic shock, but all vasopressors have adverse effects, including myocardial ischemia and arrhythmias.

Moreover, in vasoplegic situations, vascular smooth muscle cells may become unresponsive to vasopressors.

Physiologically, the renin-angiotensin-aldosterone system (RAAS) is a hormone system that plays a central role in regulating blood pressure and fluid balance, glomerular filtration rate, and electrolyte levels.

Who Took Part

Enrollment: 1022 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: Cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG) surgery, valve surgery, or combined CABG/valve surgery. Elevated risk of AKI as predicted by a score ≥ 1.5 on the following scale:. Age \> 70 years =1.5. New York Heart Association Classification (NYHA) 4 =1.5. Body Mass Index (BMI) \> 30 =1.5.

The full record lists 9 inclusion and 11 exclusion criteria; among the exclusions: major aortic surgery (aortic arch replacement), transplant surgery, pulmonary thrombendarterectomy, ventricular assist device placement; already receiving inotropic/vasopressor support before surgery; dialysis dependent.

How the Study Was Run

The set-up was 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.

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

As a double-blind Angiotensin II study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2025-03-31 with completion listed for 2027-01.

It ran at 4 sites in Germany (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Major Adverse Kidney Events (MAKE90), Severity of Acute Kidney Injury and Development or progression of chronic kidney injury.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Angiotensin II in 1022 people.

With 1022 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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