VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial
Status:
Recruiting
Trial end date:
2027-04-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Tiohundra AB
Collaborators:
Sahlgrenska University Hospital, Sweden Stockholm South General Hospital