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ClinicalTrials.gov ID

NCT05139849

Lead Sponsor

Tiohundra ABINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

1,276Estimated

Last Update Posted

Jan 20, 2022Actual

Start Date

Nov 17, 2021Actual

Primary Completion Date

Jan 31, 2027Estimated

Completion Date

Apr 30, 2027Estimated

Official Title

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

Brief 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.

• Cardiac Arrest;In-hospital Cardiac Arrest; Methylprednisolone; Vasopressin; Adrenaline; Randomized Clinical Trial

• Vasopressin; Methylprednisolone; Hydrocortisone
• Sodium chloride

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Tiohundra ABINDUSTRY

Collaborators

Sahlgrenska University HospitalOTHER

Stockholm South General HospitalOTHER

sune.forsberg@tiohundra.se+46722037953