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Effect of Vasopressin, Steroid, and Epinephrine Treatment in Patients With Out-of-hospital Cardiac Arrest

Plain-language guide to NCT03317197: phase 4 randomized trial of Vasopressin, 834 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03317197
Phase
phase 4
Status
status unknown
Start
2018-01-01
Completion (planned or actual)
2020-08-09
Participants
834 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Cardiac Arrest
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Vasopressin.

Steroid use could be considered for patients with weaker adrenal function among those with post-cardiac arrest (CA) return of spontaneous circulation (ROSC), according to the former study.

This finding is consistent with the medical background of this present study.

It had four arms (groups): Control Group (placebo comparator), Experimental Group 1 (active comparator), Experimental Group 2 (active comparator) and Experimental Group 3 (experimental).

The registry classes the interventions as drug.

More on the Plan

It is an essential issue for patients, as well as their families and local communities.

In one study, steroid use in post-cardiac arrest (CA) patients with return of spontaneous circulation (ROSC) was investigated by examining the levels of blood cortisol and adrenal corticotropic hormone.

Therefore, steroid use could be considered for patients with weaker adrenal function among those with post-cardiac arrest (CA) return of spontaneous circulation (ROSC), according to the study.

It is possible that steroid use not only assists the adrenal function in post-cardiac arrest (CA) patients but also positively influences their spontaneous circulation recovery and neurological prognosis.

Who Took Part

834 planned participants were the target.

It was open to people of any sex aged from 19 years with no upper age limit.

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

Examples of who could join: The group of patients who participated in the study included adults aged at least 19 years among the atraumatic CA outpatients who came to the ER and received CPR.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: pregnant women and young children aged \<18 years;; patients with underlying disease cases without the possibility of resuscitation (e.g., terminal cancer);; patients with do-not-resuscitate (dnr) status;.

How the Study Was Run

It was run as a randomized, factorial and double-blind study.

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

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 and care provider.

It started in 2018-01-01 with completion listed for 2020-08-09.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Examined for neurological prognosis of each group (time frame: survival discharge, through study completion, an average of 1 year).

It also tracked 1 secondary outcome, for example Examined for return of spontaneous circulation (ROSC) status.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Vasopressin in 834 people.

With 834 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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.