Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation

What Was Tested

The trial (phase 3) is built around Vasopressin.

This is a randomized, double blind, multicenter study following surgery with extracorporeal circulation to compare blood pressure optimization with vasopressin versus noradrenaline.

It is planned to include 840 patients in order to have 420 patients with vasoplegic syndrome.

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

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 840 planned participants were the target.

It was open to people of any sex aged from 70 years with no upper age limit.

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

Examples of who could join: Patient who has given free, written and informed consent. Patient of legal age. Negative pregnancy test for women of childbearing age. Patient requiring cardiac surgery:. Scheduled (\> 24h).

The full record lists 9 inclusion and 14 exclusion criteria; among the exclusions: patient subject to a measure of legal protection (curatorship, guardianship),; pregnant, parturient or breastfeeding women,; patients of legal age who are incapable or unable to express their consent,.

How the Study Was Run

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

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

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

Blinding on both sides kept the participants and researchers unaware of who received Vasopressin.

Those kept unaware of assignments: participant and investigator.

It started in 2023-01-02 with completion listed for 2026-03.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Vasopressin in 840 people.

With 840 participants it is a large trial for this field.

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

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