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Not yet recruitingNCT07442071Low-EPIUpdated Mar 2, 2026

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

A Phase 3 interventional study of Epinephrine 0.5 mg intravenous bolus and Epinephrine 1 mg intravenous bolus in Out-of-hospital Cardiac Arrest (OHCA), sponsored by Central Hospital, Nancy, France. Not yet recruiting at 26 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by Central Hospital, Nancy, France · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
4,336
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Out-of-hospital Cardiac Arrest (OHCA)

Keywords

  • Epinephrine,
  • Cardiac Arrest
  • Neurological Outcome
  • Emergency Medicine
03

In context

Out-of-Hospital Cardiac Arrest

323 studies on the registry are indexed under Out-of-Hospital Cardiac Arrest; 89 are open to participants now.

This study's planned enrollment of 4,336 is above the median of 218 across 183 interventional studies indexed under Out-of-Hospital Cardiac Arrest.

Browse Out-of-Hospital Cardiac Arrest studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
4,336 participants (estimated)

Study arms

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

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

    Drug: Epinephrine 0.5 mg intravenous bolus

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

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

    Drug: Epinephrine 1 mg intravenous bolus

Interventions

  • DrugEpinephrine 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

  • DrugEpinephrine 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.

06

What researchers measure

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.

    Time frame: 28-day

Secondary outcomes

  1. Return of Spontaneous Circulation (ROSC).

    Return of Spontaneous Circulation (ROSC) during cardiopulmonary resuscitation, defined as clinical signs of life including palpable pulse or blood pressure.

    Time frame: Periprocedural period of cardiopulmonary resuscitation

  2. Vital status

    Survival at hospital admission.

    Time frame: Periprocedural period of cardiopulmonary resuscitation

  3. vital status

    28-day survival

    Time frame: 28 days post-cardiac arrest

  4. Modified Rankin Scale (mRS) score.

    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.

    Time frame: 28 days post-cardiac arrest

07

Study locations

26 sites
  • 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
    • Romain BARDELAY, MD · Contact · secretariat@samu91.org · 0033161696169
    • Romain BARDELAY, MD · Principal investigator
  • Brigade de Sapeurs-Pompiers de Paris
    Courbevoie, France
  • Centre Hospitalier Universitaire Grenoble Alpes
    La Tronche, France
    • Nicolas SEGOND, MD · Contact · nsegond@chu.grenoble.fr · 0033476767575
    • Nicolas SEGOND, MD · Principal investigator
  • 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
    • Julie CONTENTI, MD PHD · Contact · contenti.j@chu-nice.fr · +33 4 92 03 77 77
    • Julie Contenti, MD PhD · Principal investigator
  • CHU Nimes
    Nîmes, France
  • AP-HP Hôpital Necker
    Paris, France
    • Alice HUTIN, MD · Contact · alice.hutin@aphp.fr · +33 1 44 49 40 00
    • Alice HUTIN, MD · Principal investigator
  • Hopital Beaujon
    Paris, France
    • Bénédicte DOUAY, MD · Contact · benedicte.douay@aphp.fr · +33 1 40 87 50 00
    • Benedicte Douay, MD · Principal investigator
  • hôpital Lariboisière
    Paris, France
    • Anthony CHAUVIN, MD PHD · Contact · anthony.chauvin@aphp.fr · +33 1 49 95 65 65
    • clementine.cassard@aphp.fr · Contact
    • Anthony Chauvin, MD PhD · Principal investigator
  • La Pitié Salpêtrière
    Paris, France
    • Clémentine Cassard, MD · Contact · +33 1 42 16 00 00
    • clementine.cassard@aphp.fr · Contact
    • Célmentine Cassard, MD · Principal investigator
  • Raymond Poincaré Hospital
    Paris, France
    • Armelle Severin, MD · Contact · armelle.severin@aphp.fr · +33 1 47 10 79 00
    • Armelle Severin, MD · Principal investigator
  • CHU Poitiers
    Poitiers, France
  • Centre Hospitalier Universitaire Reims
    Reims, France
    • Stéphane GENNAI, MD · Contact · s.gennai@chu-reims.fr · 0033326787878
    • Stéphane GENNAI, MD · Principal investigator
  • CHU Rennes
    Rennes, France
  • CHU Rouen
    Rouen, France
    • Marie OZANNE, MD · Contact · m.ozanne@chu-rouen.fr · +33 2 32 88 89 90
    • Marie Ozanne, MD · Principal investigator
  • Centre hospitalier Annecy Genevois Site Julien en GENEVOIS
    Saint-Julien-en-Genevois, France
  • Centre Hospitalier Universitaire De Toulouse
    Toulouse, France
  • CHU Tours
    Tours, France
    • Alexandre JEZIORNY, MD · Contact · a.JEZIORNY@chu-tours.fr · +33 2 47 47 47 47
    • Alexandre JEZIORNY, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07442071
Lead sponsor
Central Hospital, Nancy, France
Responsible party
CHOUIHED Tahar (Coordinating Investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
Mar 2, 2026
Start date
Jun 2026 (estimated)
Primary completion
Jul 2030 (estimated)
Completion
Jul 2030 (estimated)
Last update
Mar 2, 2026

Study contacts

Tahar CHOUIHED, MD, PhD
Contact
T.CHOUIHEDMAHJOUB@chru-nancy.fr
0033383157322
Nicolas Girerd, MD PhD
Contact
n.girerd@chru-nancy.fr
0033383157322

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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