VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vasopressin; Methylprednisolone; Hydrocortisone, Sodium chloride.
- Who it may be relevant to
- Registry conditions: Cardiac Arrest;In-hospital Cardiac Arrest; Methylprednisolone; Vasopressin; Adrenaline; Randomized Clinical Trial. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Vasopressin; Methylprednisolone; Hydrocortisone
Vasopressin, the vasoconstrictive hypophysal hormone, alone has not shown increased survival when compared to adrenaline. However, animal data have shown increased diastolic pressure, cerebral perfusion pressure and cerebral oxygenation in cardiac arrest treatment with vasopressin, and have when compared to adrenaline been associated with better cerebral blood flow. Corticosteroids are currently used in septic shock treatment as a means to reduce time to shock reversal and thereby potentially i - Drug Sodium chloride
Sodium chloride 9 mg/ml
Primary outcome measures
- Survival at 30 days [Time frame: Survival at 30 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Sweden · 2 centers
- Sahlgrenska University Hospital — Gothenburg
- Tiohundra — Norrtälje
Publications
- Andersen LW, Holmberg MJ, Hoybye M, Isbye D, Kjaergaard J, Darling S, Zwisler ST, Larsen JM, Rasmussen BS, Iversen K, Schultz M, Sindberg B, Fink Valentin M, Granfeldt A. Vasopressin and methylprednisolone and hemodynamics after in-hospital cardiac arrest - A post hoc analysis of the VAM-IHCA trial. Resuscitation. 2023 Oct;191:109922. doi: 10.1016/j.resuscitation.2023.109922. Epub 2023 Aug 3. PMID 37543161
Identifiers
NCT: NCT05139849 · VAST-A.Studyprotocol.Version_4