Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05139849

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

Led by Tiohundra AB · Updated on 2022-01-20

1276

Participants Needed

2

Research Sites

284 weeks

Total Duration

On this page

Sponsors

T

Tiohundra AB

Lead Sponsor

S

Sahlgrenska University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Hospitalized men over 18 years old
  • Hospitalized women over 50 years old
Not Eligible

You will not qualify if you...

  • Patients unable to understand information to decide about study participation
  • Women who are premenopausal or of childbearing potential
  • Patients with a do not resuscitate (DNR) decision
  • Patients previously enrolled and randomized in the trial

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Sahlgrenska University Hospital

Gothenburg, Sweden

Actively Recruiting

2

Tiohundra

Norrtälje, Sweden

Actively Recruiting

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Research Team

S

Sune Forsberg, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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