VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial
NCT05139849
Phase
Phase 3
Recruitment status
Recruiting
Participants
1,276
Lead sponsor
Tiohundra AB
Start date
2021-11-17
Number of sites
- 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.
- Acronym
- VAST-A
- Short title
- VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial
- Official title
- VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-04-30
- First posted
- 2021-12-01
- Registry last updated
- 2022-01-20
- Primary completion date
- 2027-01-31
- Start date
- 2021-11-17
- Participants
- 1,276
- Participant count basis
- Estimated
- Planned participants
- 1,276
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Tiohundra AB
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05139849
- ClinicalTrials.gov ID
- NCT05139849
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
Survival at 30 days
Timeframe: Survival at 30 days
Survival at 30 days
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Hospitalized men > 18 years and hospitalized women > 50 years.
- 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
Sources for eligibility
- Sahlgrenska University HospitalGothenburg, SwedenRecruiting
- TiohundraNorrtälje, SwedenRecruiting
Sources for sites
- PubMed 37543161Related publication
Sources for references
Related records
Drugs (3)
Collaborators (2)
- Sahlgrenska University Hospital
- Stockholm South General Hospital
Lead sponsors (1)
Conditions (2)
- Cardiac arrest Primary condition
- Diabetes insipidus