Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients

What Was Tested

In this phase 3 trial, researchers set out to test Vasopressin.

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

The registry classes the interventions as drug.

Who Took Part

250 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.

Examples of who could join: Solid neoplasm needing ICU. Septic Shock according standard criteria.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: younger than 18 years;; raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;; severe hyponatremia (na\<130meq/l);.

How the Study Was Run

Design: randomized, parallel-group 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.

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

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 2012-11 with completion listed for 2014-03.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 28-day mortality (time frame: 28-day from randomization).

It also tracked 6 secondary outcomes, for example 90-days mortality, Days alive and free of mechanical ventilation, Days alive and free of vasopressors, Days alive and free of renal replacement therapy, SOFA score in 24 hours and SOFA score in 96 hours.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Vasopressin in 250 people.

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

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