Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

What Was Tested

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

This is a randomized, open label study to investigate vasopressin versus phenylephrine as a first line pressor in cardiac surgery.

All patients \>18 years of age presenting for coronary artery bypass graft (CABG), valve surgery, or combined CABG and valve surgery will be screened for inclusion.

It had two arms (groups): Vasopressin (experimental) and Phenylephrine (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 300 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: \>18 years of age. Coronary artery bypass graft (CABG), valve, or combined CABG and valve surgery.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: \> moderate pulmonary hypertension; \> mild right ventricular dysfunction; radial arterial graft.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Being open-label, the Vasopressin study did not mask who received what.

It started in 2020-10-15 with completion listed for 2024-05-29.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Number of patients with acute kidney injury (time frame: 5 Days).

It also tracked 6 secondary outcomes, for example Number of patients with 30-Day Mortality, Number of patients with reoperation, Number of patients with sternal Infection, Number of patients with Atrial Fibrilation, ICU Length of Stay and Total Vasopressor Hours.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Vasopressin in 300 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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