Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Hospitalized men over 18 years old
- Hospitalized women over 50 years old
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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
2
Tiohundra
Norrtälje, Sweden
Actively Recruiting
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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