Impact of Low Dose Epinephrine in the Management of Out-of-hospital Cardiac Arrest on Neurological Outcome: A Multicenter Randomized and Double-blind Trial.
| Registry | NCT07442071, acronym Low-EPI |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 4336 (Estimated) |
| Sponsor | Central Hospital, Nancy, France (Other) |
| Conditions | Out-of-hospital Cardiac Arrest (OHCA) |
| Interventions | Epinephrine 0.5 mg intravenous bolus, Epinephrine 1 mg intravenous bolus (Drug) |
| Dates | start 2026-06-01 (estimated), primary completion 2030-07-01 (estimated), completion 2030-07-01 (estimated), first posted 2026-03-02, last updated 2026-03-02 |
| Locations | 26 sites in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Out-of-hospital Cardiac Arrest (OHCA) All trials of Epinephrine 0.5 mg intravenous bolus All trials of Epinephrine 1 mg intravenous bolus
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation | Experimental | Drug: Epinephrine 0.5 mg intravenous bolus | Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation |
| Epinephrine 1 mg IV bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation | Active comparator | Drug: Epinephrine 1 mg intravenous bolus | Epinephrine 1 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| CH Annecy | Annecy | France | |
| Centre hospitalier de la Côte Basque | Bayonne | France | |
| CHU Besancon | Besançon | France | |
| CHU Brest | Brest | France | |
| CHU Colmar | Colmar | France | |
| CH SUD Francilien | Corbeil-Essonnes | France | |
| Brigade de Sapeurs-Pompiers de Paris | Courbevoie | France | |
| Centre Hospitalier Universitaire Grenoble Alpes | La Tronche | France | |
| Hospices Civils De Lyon | Lyon | France | |
| CHU Montpellier | Montpellier | France | |
| CHRU Nancy | Nancy | France | |
| Centre Hospitalier Universitaire De Nantes | Nantes | France | |
| CHU Nice | Nice | France | |
| CHU Nimes | Nîmes | France | |
| AP-HP Hôpital Necker | Paris | France | |
| Hopital Beaujon | Paris | France | |
| hôpital Lariboisière | Paris | France | |
| La Pitié Salpêtrière | Paris | France | |
| Raymond Poincaré Hospital | Paris | France | |
| CHU Poitiers | Poitiers | France | |
| Centre Hospitalier Universitaire Reims | Reims | France | |
| CHU Rennes | Rennes | France | |
| CHU Rouen | Rouen | France | |
| Centre hospitalier Annecy Genevois Site Julien en GENEVOIS | Saint-Julien-en-Genevois | France | |
| Centre Hospitalier Universitaire De Toulouse | Toulouse | France | |
| CHU Tours | Tours | France |
NIH grants: 2023