Vasopressin, Epinephrine, and Steroids for Cardiac Arrest

What Was Tested

This registered phase 3 trial tested Vasopressin.

This hypothesis is supported by the single-center results of NCT 00411879.

The investigators intend to either refute or provide definitive evidence supporting this hypothesis (and its generalizability) by conducting the present multicenter, randomized, controlled clinical trial of in hospital cardiac arrest.

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

Patients with refractory, inhospital cardiac arrest, i.e., with asystole, pulseless electrical activity, or ventricular fibrillation/pulseless ventricular tachycardia not responsive to two attempts at defibrillation.

Patients with refractory, inhospital cardiac arrest, i.e., with asystole, pulseless electrical activity, or ventricular fibrillation/pulseless ventricular tachycardia not responsive to two attempts at defibrillation.

The registry classes the interventions as drug.

More on the Plan

Thus, the investigators intend to either refute or provide definitive evidence supporting this hypothesis (and its generalizability) by conducting the present multicenter, randomized, controlled clinical trial of inhospital cardiac arrest.

Apart from the initial, combined drug administration in the study group, CPR is conducted in full concordance with the 2005 Guidelines for Advanced Life Support (5).

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 and results in patient exclusion, unless the prescribed corticosteroid regimen is in full concordance with the above-described, protocolized one.

Who Took Part

The registry lists 300 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 patients with refractory inhospital cardiac arrest, defined as epinephrine requirement for ventricular fibrillation/tachycardia or asystole/pulseless electrical activity according to guidelines for resuscitation 2005 (5).

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: age \< 18 years; terminal illness or do-not resuscitate status; cardiac arrest due to exsanguination.

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.

The Vasopressin group and the comparison group ran side by side rather than switching.

As a double-blind Vasopressin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2008-09 with completion listed for 2010-11.

It ran at 3 sites in Greece (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Return of Spontaneous Circulation for at least 15 min and Survival to Hospital Discharge with or without neurological recovery (time frame: 60 days).

It also tracked 3 secondary outcomes, for example The number of organ failure-free days during follow-up and Complications related to the use of steroids.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Vasopressin in 300 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.