VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinic
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
| Condition(s) | Cardiac Arrest;In-hospital Cardiac Arrest; Methylprednisolone; Vasopressin; Adrenaline; Randomized Clinical Trial |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 capa |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Tiohundra AB |
| Locations | Gothenburg, Sweden; Norrtälje, Sweden |
| Start date | 2021-11-17 |
| NCT ID | NCT05139849 |
| Official listing | https://clinicaltrials.gov/study/NCT05139849 |