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Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest

Plain-language guide to NCT00358579: phase 3 randomized trial of Vasopressin, 727 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00358579
Phase
phase 3
Status
completed
Start
2006-03
Completion (planned or actual)
2009-01
Participants
727 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Cardiac Arrest
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

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

Historically intravenous adrenaline has been the drug of choice since 1906.

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

The registry classes the interventions as drug.

More on the Plan

Historically intravenous adrenaline has been the recommended drug of choice since 1906.

More recently, vasopressin has been used in patients with cardiac arrest.

In human studies on vasopressin, clinical trials have produced conflicting results.

The current study compared vasopressin and adrenaline in the treatment of cardiac arrest in patients presenting to the Emergency Department (ED).

Who Took Part

The registry lists 727 actual participants took part.

It was open to people of any sex aged from 17 years with no upper age limit.

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

Examples of who could join: Patient with cardiac arrest as confirmed by the absence of a pulse, unresponsiveness and apnea. Age above 16 (Age 21 and above for CGH only).

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: traumatic cardiac arrest; age 16 and below (age 20 and below for cgh only); CPR is contraindicated.

How the Study Was Run

The set-up was randomized, parallel-group and double-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.

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

Blinding on both sides kept the participants and researchers unaware of who received Vasopressin.

Those kept unaware of assignments: participant and investigator.

It started in 2006-03 with completion listed for 2009-01.

It ran at 4 sites in Singapore (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged, Neurological Status at 1 Year, Return of Spontaneous Circulation and Survival to Admission.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Vasopressin in 727 people.

With 727 participants it is a large trial for this field.

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.

Our Notes on the Compound

Vasopressin: A 9-amino-acid hormone (antidiuretic hormone) that controls water balance and blood vessel tone; used in septic shock.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.