Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients:

What Was Tested

This registered phase 3 trial tested Vasopressin.

It had two arms (groups): use of vasopressin (active comparator) and use of norepinephrine (active comparator).

Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients.

Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients.

The registry classes the interventions as drug.

More on the Plan

The researchers hypothesize that the use of vasopressin compared with norepinephrine induces a lower mPAP-to-MAP ratio, in cardiac surgical patients with and without pulmonary hypertension who require intraoperative vasopressor support.

Who Took Part

Enrollment: 164 actual participants took part.

It was open to people of any sex aged from 19 years with no upper age limit.

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

Examples of who could join: Elective cardiac surgery with the use of CPB. Patients with pulmonary artery catheter insertion. Systemic hypotension (MAP \< 70 mmHg) requiring continuous infusion of vasopressor.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: transplant surgery; ventricular assist device implantation other than intra-aortic balloon counter-pulsation; pulmonary endarterectomy.

How the Study Was Run

Design: randomized, crossover and open-label.

Because people in this Vasopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Vasopressin and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Vasopressin study: the participants and staff both knew the treatment.

It started in 2020-11-05 with completion listed for 2023-08-22.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: mPAP-to-MAP Ratio (time frame: during 20 minute period after chest closure).

It also tracked 1 secondary outcome, for example RV Free Wall Strain.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Vasopressin in 164 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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