NCT07442071

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,336

participants targeted

Target at P75+ for phase_3

Timeline
48mo left

Started Jun 2026

Typical duration for phase_3

Geographic Reach
1 country

26 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jul 2030

First Submitted

Initial submission to the registry

February 9, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

4.1 years

First QC Date

February 9, 2026

Last Update Submit

February 26, 2026

Conditions

Keywords

Epinephrine,Cardiac ArrestNeurological OutcomeEmergency Medicine

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale (mRS) score

    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.

    28-day

Secondary Outcomes (4)

  • Return of Spontaneous Circulation (ROSC).

    Periprocedural period of cardiopulmonary resuscitation

  • Vital status

    Periprocedural period of cardiopulmonary resuscitation

  • vital status

    28 days post-cardiac arrest

  • Modified Rankin Scale (mRS) score.

    28 days post-cardiac arrest

Study Arms (2)

Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation

EXPERIMENTAL

Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation

Drug: Epinephrine 0.5 mg intravenous bolus

Epinephrine 1 mg IV bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation

ACTIVE COMPARATOR

Epinephrine 1 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation

Drug: Epinephrine 1 mg intravenous bolus

Interventions

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 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation

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.

Epinephrine 1 mg IV bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

CH Annecy

Annecy, France

Location

Centre hospitalier de la Côte Basque

Bayonne, France

Location

CHU Besancon

Besançon, France

Location

CHU Brest

Brest, France

Location

CHU Colmar

Colmar, France

Location

CH SUD Francilien

Corbeil-Essonnes, France

Location

Brigade de Sapeurs-Pompiers de Paris

Courbevoie, France

Location

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, France

Location

Hospices Civils De Lyon

Lyon, France

Location

CHU Montpellier

Montpellier, France

Location

CHRU Nancy

Nancy, France

Location

Centre Hospitalier Universitaire De Nantes

Nantes, France

Location

CHU Nice

Nice, France

Location

CHU Nimes

Nîmes, France

Location

AP-HP Hôpital Necker

Paris, France

Location

Hopital Beaujon

Paris, France

Location

hôpital Lariboisière

Paris, France

Location

La Pitié Salpêtrière

Paris, France

Location

Raymond Poincaré Hospital

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

Centre Hospitalier Universitaire Reims

Reims, France

Location

CHU Rennes

Rennes, France

Location

CHU Rouen

Rouen, France

Location

Centre hospitalier Annecy Genevois Site Julien en GENEVOIS

Saint-Julien-en-Genevois, France

Location

Centre Hospitalier Universitaire De Toulouse

Toulouse, France

Location

CHU Tours

Tours, France

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHeart Arrest

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Central Study Contacts

Tahar CHOUIHED, MD, PhD

CONTACT

Nicolas Girerd, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating Investigator

Study Record Dates

First Submitted

February 9, 2026

First Posted

March 2, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations