Combined Vasopressin, Methylprednisolone, and Epinephrine for Inhospital Cardiac Arrest

What Was Tested

In this phase 2 trial, researchers set out to test Vasopressin.

Also, postresuscitation abnormalities mimic severe sepsis.

It had two arms (groups): Control Group (placebo comparator) and Study Group (experimental).

Patients with refractory cardiac arrest (as defined in methods) treated according to the latest guidelines for resuscitation and receiving placebo instead of vasopressin and corticosteroids.

The registry classes the interventions as drug.

More on the Plan

The mechanistic basis of this hypothesis comprises the simultaneous activation of adrenergic and vasopressin receptors, in conjunction with a potential steroid-mediated enhancement of the vascular reactivity to epinephrine.

Apart from the initial, combined drug administration in the study group, CPR is conducted in full concordance with the 2005 European Resuscitation Council Guidelines.

This holds also for study group patients during the follow-up period.

Any steroid prescription by attending physicians cancels any concomitant investigational interventions regarding steroid supplementation.

Who Took Part

Enrollment: 100 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: Adult in-patients with cardiac arrest requiring epinephrine according to current guidelines.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: age \< 18 years; documented terminal illness (life expectancy \< 6 weeks); do not resuscitate status.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

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 2006-06 with completion listed for 2007-04.

It ran at 1 site in Greece.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 1) Return of Spontaneous Circulation for > 15 min and 2) Survival to discharge either to home or to a rehabilitation facility (time frame: 60 days (actual)).

It also tracked 5 secondary outcomes, for example Sequential Organ Dysfunction Assessment Score during follow-up. Organ failure free days, Neurological status during follow-up, Cerebral performance during follow-up and at discharge, Peri-arrest arterial pressure and Plasma cytokine concentration.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Vasopressin in 100 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.