Impact of Low Dose Epinephrine in the Management of Out-of-hospital Cardiac Arrest on Neurological Outcome

NCT07442071 — Phase 3, Not yet recruiting, 4336 participants, Central Hospital, Nancy, France

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Impact of Low Dose Epinephrine in the Management of Out-of-hospital Cardiac Arrest on Neurological Outcome: A Multicenter Randomized and Double-blind Trial.

RegistryNCT07442071, acronym Low-EPI
StatusNot yet recruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment4336 (Estimated)
SponsorCentral Hospital, Nancy, France (Other)
ConditionsOut-of-hospital Cardiac Arrest (OHCA)
InterventionsEpinephrine 0.5 mg intravenous bolus, Epinephrine 1 mg intravenous bolus (Drug)
Datesstart 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
Locations26 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

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary ResuscitationExperimentalDrug: Epinephrine 0.5 mg intravenous bolusEpinephrine 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 ResuscitationActive comparatorDrug: Epinephrine 1 mg intravenous bolusEpinephrine 1 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation
  • Epinephrine 0.5 mg intravenous bolus (Drug): 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
  • Epinephrine 1 mg intravenous bolus (Drug): 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.

+Outcome measures

Primary outcomes

  • Modified Rankin Scale (mRS) score [28-day]: The mRS score is a validated score measuring neurologic outcomes after cardio-pulmonary resuscitation (CPR) : * mRS 0. No symptoms. * mRS 1. No significant disability. Able to perform all usual activities, despite some symptoms. * mRS 2. Slight disability. Independent but unable to perform usual activities (work, sports, leisure). mRS 3. Moderate disability. Requires assistance, but able to walk alone. * mRS 4. Moderately severe disability. Walking assistance and daily living activities not possible. mRS 5. Major disability. Bedridden, incontinent and requires constant nursing care and attention. * mRS 6. Death.

Secondary outcomes

  • Return of Spontaneous Circulation (ROSC). [Periprocedural period of cardiopulmonary resuscitation]: Return of Spontaneous Circulation (ROSC) during cardiopulmonary resuscitation, defined as clinical signs of life including palpable pulse or blood pressure.
  • Vital status [Periprocedural period of cardiopulmonary resuscitation]: Survival at hospital admission.
  • vital status [28 days post-cardiac arrest]: 28-day survival
  • Modified Rankin Scale (mRS) score. [28 days post-cardiac arrest]: Modified Rankin Scale (mRS) score used as a continuous variable (in contrast with the use of the mRS scale in the primary outcome). The mRS score is a validated score measuring neurologic outcomes after cardio-pulmonary resuscitation (CPR) : * mRS 0. No symptoms. * mRS 1. No significant disability. Able to perform all usual activities, despite some symptoms. * mRS 2. Slight disability. Independent but unable to perform usual activities (work, sports, leisure). mRS 3. Moderate disability. Requires assistance, but able to walk alone. * mRS 4. Moderately severe disability. Walking assistance and/or daily living activities not possible. mRS 5. Major disability. Bedridden, incontinent and requires constant nursing care and attention. * mRS 6. Death. The mRS score will be assessed 28 days after cardiac arrest.

+Eligibility

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

+Locations (26)

FacilityCityCountryStatus
CH AnnecyAnnecyFrance
Centre hospitalier de la Côte BasqueBayonneFrance
CHU BesanconBesançonFrance
CHU BrestBrestFrance
CHU ColmarColmarFrance
CH SUD FrancilienCorbeil-EssonnesFrance
Brigade de Sapeurs-Pompiers de ParisCourbevoieFrance
Centre Hospitalier Universitaire Grenoble AlpesLa TroncheFrance
Hospices Civils De LyonLyonFrance
CHU MontpellierMontpellierFrance
CHRU NancyNancyFrance
Centre Hospitalier Universitaire De NantesNantesFrance
CHU NiceNiceFrance
CHU NimesNîmesFrance
AP-HP Hôpital NeckerParisFrance
Hopital BeaujonParisFrance
hôpital LariboisièreParisFrance
La Pitié SalpêtrièreParisFrance
Raymond Poincaré HospitalParisFrance
CHU PoitiersPoitiersFrance
Centre Hospitalier Universitaire ReimsReimsFrance
CHU RennesRennesFrance
CHU RouenRouenFrance
Centre hospitalier Annecy Genevois Site Julien en GENEVOISSaint-Julien-en-GenevoisFrance
Centre Hospitalier Universitaire De ToulouseToulouseFrance
CHU ToursToursFrance

+Funding

NIH grants: 2023