VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial

Last updated: January 19, 2022
Sponsor: Tiohundra AB
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05139849
VAST-A.Studyprotocol.Version_4
  • Ages > 18
  • All Genders

Study Summary

This is an investigator initiated randomized, placebo controlled, double blind, superiority, multi-centre clinical trial. The estimated study project period runs over 3-4 years, including pilot phase. Based on preliminary assumptions, to confirm or reject an increase in survival from 9% to 14%, about1400 patients will be randomized in the study. In hospital cardiac arrest patients meeting criteria(s) for adrenaline administration according to current ERC guidelines are eligible for randomization in the study.

Informed consent for participating in the study cannot be obtained from the subject at the scene of the cardiac arrest since the victim is unconscious. Therefore, all hospitalized men > 18 years and women > 50 years, except those fulfilling the exclusion criterias; patients not capable to comprehend information to decide about participation in the study, women considered of childbearing potential (WOCBP)) and do not resuscitate (DNR) decision will be informed and asked about consent to participate in the study and in the case of cardiac arrest during the actual hospital stay randomized to either treatment. Only those patients experiencing an in hospital cardiac arrest meeting criteria(s) for adrenaline administration will be randomized.

Patients will be randomized to, in addition adrenaline, either treatment with vasopressin and steroids (intervention) or sodium chloride (placebo) (control).

Primary outcome is survival at 30 days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Hospitalized men > 18 years and hospitalized women > 50 years.

Exclusion

Exclusion Criteria:

  • Patients not capable to comprehend information to decide about participation in thestudy
  • Women considered of childbearing potential (WOCBP) i. e. premenopausal women
  • Patients with do not resuscitate (DNR) descision
  • Prior enrollment and randomization in the trial

Study Design

Total Participants: 1276
Study Start date:
November 17, 2021
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Active - Recruiting

  • Tiohundra

    Norrtälje,
    Sweden

    Active - Recruiting

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