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Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest

Plain-language guide to NCT03640949: phase 2, phase 3 randomized trial of Vasopressin, 501 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03640949
Phase
phase 2, phase 3
Status
completed
Start
2018-09-17
Completion (planned or actual)
2021-01-21
Participants
501 (actual)
Design
randomized, quadruple-blind, treatment
Conditions studied
Heart Arrest
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 2, phase 3 trial tested Vasopressin.

The primary outcome is return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.

It had two arms (groups): Vasopressin and methylprednisolone (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

501 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: In-hospital cardiac arrest. Age ≥ 18 years.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: clearly documented "do-not-resuscitate" order prior to the cardiac arrest; prior enrollment in the trial; invasive mechanical circulatory support at the time of the cardiac arrest.

How the Study Was Run

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

The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

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 2018-09-17 with completion listed for 2021-01-21.

It ran at 10 sites in Denmark (10).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Return of Spontaneous Circulation (time frame: During the cardiac arrest, an average of 20 minutes).

It also tracked 2 secondary outcomes, for example Number of Participants That Survived 30 Days and Number of Participants With a Favorable Neurological Outcome at 30 Days.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Vasopressin in 501 people.

With 501 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.