Reducing Acute Kidney Injury Occurence by Administering Angiotensin II

What Was Tested

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

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

Intravenous infusion placebo (matched infusion volume) over 12 h after start of infusion.

The registry classes the interventions as drug.

More on the Plan

Patients with vasoplegic shock after cardiac surgery are at higher risk of organ failure, including acute kidney injury (AKI).

Prior studies often started with the interventions after an AKI event, when a decline of kidney function (i.e. glomerular filtration rate) was already established.

Application of norepinephrine is currently considered as the first-line therapy for vasoplegic shock, but all catecholamines have adverse effects, including myocardial ischemia and arrhythmias.

Cardiopulmonary bypass (CPB) represents a common clinical setting of sympathetic nervous system activation and cardiovascular instability.

Who Took Part

The registry lists 64 actual participants took part.

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.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: preexisting aki (stage 1 and higher); patients with cardiac assist devices; pregnant women, nursing women and women of childbearing potential.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Angiotensin II group and the comparison group should start out alike.

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 2021-12-27 with completion listed for 2022-12-19.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: • kidney damage after cardiac surgery identified by the difference between [TIMP-2]*[IGFBP7] levels 12h after randomization and [TIMP-2]*[IGFBP7] levels at randomization (time frame: 12 hours after start of intervention).

It also tracked 17 secondary outcomes, for example Severity of Acute Kidney Injury, Amount of volume application, Fluid status, Creatinine clearance on day one after cardiac surgery, Free-days through day 28 of vasoactive medications and mechanical ventilation and Renal Recovery.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Angiotensin II in 64 people.

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

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