Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery

What Was Tested

The trial (phase 3) is built around Vasopressin.

Vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery, with negative impact on patient outcomes and hospital costs.

Pathogenesis of vasodilatory phenomenon after cardiac surgery remains a matter of controversy.

Loss of vascular tone can be partly explained by the depletion of neurohypophyseal arginine vasopressin stores.

It had two arms (groups): Norepinephrine group (active comparator) and Vasopressin Group (active comparator).

Blinded norepinephrine.

Blinded vasopressin.

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: Need vasopressor support.

The full record lists 1 inclusion and 12 exclusion criteria; among the exclusions: younger than 18 years;; surgery without cardiopulmonary bypass;; emergency procedure;.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

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.

In the crossover set-up each of the participants took both Vasopressin and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Vasopressin, so expectations could not easily colour the readings.

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

It started in 2012-01 with completion listed for 2013-02.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Composite endpoint of major morbidity according to Society of Thoracic Surgery (time frame: 30 days).

It also tracked 5 secondary outcomes, for example Hemodynamic effects, Time on mechanical ventilation, Incidence of infecction and Length of ICU and Hospital stay.

What This Means in Plain Language

Put simply, this is a phase 3, 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.