Impact of Low Dose Epinephrine in the Management of Out-of-hospital Cardiac Arrest on Neurological Outcome
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: Epinephrine 0.5 mg intravenous bolus, Epinephrine 1 mg intravenous bolus.
- Who it may be relevant to
- Registry conditions: Out-of-hospital Cardiac Arrest (OHCA). 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
- France
- 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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Official title
Impact of Low Dose Epinephrine in the Management of Out-of-hospital Cardiac Arrest on Neurological Outcome: A Multicenter Randomized and Double-blind Trial.
Overview
This study will test whether a lower dose of epinephrine (0.5 mg) given during emergency treatment for out-of-hospital cardiac arrest helps more patients survive with good brain function, compared to the standard dose (1 mg). Adults who experience cardiac arrest outside the hospital and are treated by emergency medical teams will be randomly assigned to receive either the low dose or the standard dose of epinephrine. The study will compare survival and neurological outcomes between the two groups over 28 days.
Interventions
- Drug Epinephrine 0.5 mg intravenous bolus
Epinephrine 0.5 mg/mL solution for injection, administered as a 0.5 mg intravenous bolus every 3 to 5 minutes during cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest. T - Drug Epinephrine 1 mg intravenous bolus
Epinephrine 1 mg/mL solution for injection, administered as a 1 mg intravenous bolus every 3 to 5 minutes during cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest.
Primary outcome measures
- Modified Rankin Scale (mRS) score [Time frame: 28-day]
Secondary outcome measures (4)
- Return of Spontaneous Circulation (ROSC). [Time frame: Periprocedural period of cardiopulmonary resuscitation]
- Vital status [Time frame: Periprocedural period of cardiopulmonary resuscitation]
- vital status [Time frame: 28 days post-cardiac arrest]
- Modified Rankin Scale (mRS) score. [Time frame: 28 days post-cardiac arrest]
Eligibility criteria
Inclusion criteria
Male or female, aged ≥18 years. Out-of-hospital cardiac arrest for which resuscitation is decided by the SMUR team.
Medical Out-of-hospital cardiac arrest. Affiliated with or beneficiary of a social security plan
Exclusion criteria
- Non-medical Out-of-hospital cardiac arrest (traumatic, drownings, electrocution, asphyxia, overdose, unknown cause).
- Out-of-hospital cardiac arrest without advanced life support (Do Not Attempt Resuscitation order, body finding, the decision not to attempt advanced life support is at the physician's discretion).
- Pregnant women, birthing or breastfeeding mothers
- Adults under legal protection measure (such as guardianship, conservatorship)
- Individuals deprived of liberty due to judicial or administrative decision
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
France · 26 centers
- CH Annecy — Annecy
- Centre hospitalier de la Côte Basque — Bayonne
- CHU Besancon — Besançon
- CHU Brest — Brest
- CHU Colmar — Colmar
- CH SUD Francilien — Corbeil-Essonnes
- Brigade de Sapeurs-Pompiers de Paris — Courbevoie
- Centre Hospitalier Universitaire Grenoble Alpes — La Tronche
- … and 18 more centers
Identifiers
NCT: NCT07442071 · 2021PI170 · 2023-505349-26-00