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

February 26, 2026 updated by: CHOUIHED Tahar, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4336

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Annecy, France
        • CH Annecy
        • Contact:
        • Principal Investigator:
          • Hugo SCHMIT, MD PhD
      • Bayonne, France
        • Centre Hospitalier de la Côte Basque
        • Contact:
        • Principal Investigator:
          • Xavier Pereira, MD
      • Besançon, France
        • CHU Besançon
        • Contact:
        • Principal Investigator:
          • Abdo KHOURY, MD
      • Brest, France
        • CHU Brest
        • Contact:
        • Principal Investigator:
          • Adrien Basset, MD
      • Colmar, France
        • CHU Colmar
        • Principal Investigator:
          • Yannick GOTTWALLES, MD
        • Contact:
      • Corbeil-Essonnes, France
        • CH Sud Francilien
        • Principal Investigator:
          • Romain BARDELAY, MD
        • Contact:
      • Courbevoie, France
        • Brigade de Sapeurs-Pompiers de Paris
        • Contact:
        • Principal Investigator:
          • Simon-Pierre CORCOSTEGUI, MD
      • La Tronche, France
        • Centre Hospitalier Universitaire Grenoble Alpes
        • Principal Investigator:
          • Nicolas Segond, MD
        • Contact:
      • Lyon, France
        • Hospices Civils de Lyon
      • Montpellier, France
      • Nancy, France
        • CHRU Nancy
        • Principal Investigator:
          • Tahar CHOUIHED, MD, PhD
        • Contact:
      • Nantes, France
        • Centre Hospitalier Universitaire de Nantes
        • Contact:
        • Principal Investigator:
          • François JAVAUDIN, MD
      • Nice, France
        • CHU Nice
        • Contact:
        • Principal Investigator:
          • Julie Contenti, MD PhD
      • Nîmes, France
        • CHU Nimes
        • Principal Investigator:
          • Fabien COISY, MD
        • Contact:
      • Paris, France
        • Hôpital Lariboisière
        • Contact:
        • Contact:
          • clementine.cassard@aphp.fr
        • Principal Investigator:
          • Anthony Chauvin, MD PhD
      • Paris, France
        • Hôpital Beaujon
        • Contact:
        • Principal Investigator:
          • Benedicte Douay, MD
      • Paris, France
        • AP-HP Hôpital Necker
        • Contact:
        • Principal Investigator:
          • Alice HUTIN, MD
      • Paris, France
        • La Pitié Salpêtrière
        • Contact:
          • clementine.cassard@aphp.fr
        • Contact:
          • Clémentine Cassard, MD
          • Phone Number: +33 1 42 16 00 00
        • Principal Investigator:
          • Célmentine Cassard, MD
      • Paris, France
        • Raymond Poincaré Hospital
        • Contact:
        • Principal Investigator:
          • Armelle Severin, MD
      • Poitiers, France
        • CHU Poitiers
        • Contact:
        • Principal Investigator:
          • Nicolas MARJANOVIC, MD PhD
      • Reims, France
        • Centre Hospitalier Universitaire Reims
        • Contact:
        • Principal Investigator:
          • Stéphane GENNAI, MD
      • Rennes, France
        • CHU Rennes
        • Contact:
        • Principal Investigator:
          • Nicolas PESCHANSKI, MD PhD
      • Rouen, France
        • CHU Rouen
        • Contact:
        • Principal Investigator:
          • Marie Ozanne, MD
      • Saint-Julien-en-Genevois, France
        • Centre hospitalier Annecy Genevois Site Julien en GENEVOIS
        • Contact:
        • Principal Investigator:
          • Arnaud RELLY, MD
      • Toulouse, France
        • Centre Hospitalier Universitaire de Toulouse
        • Principal Investigator:
          • Bertrand GUIHARD, MD
        • Contact:
      • Tours, France
        • CHU Tours
        • Contact:
        • Principal Investigator:
          • Alexandre JEZIORNY, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation
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
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (mRS) score
Time Frame: 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.
28-day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Return of Spontaneous Circulation (ROSC).
Time Frame: 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.
Periprocedural period of cardiopulmonary resuscitation
Vital status
Time Frame: Periprocedural period of cardiopulmonary resuscitation
Survival at hospital admission.
Periprocedural period of cardiopulmonary resuscitation
vital status
Time Frame: 28 days post-cardiac arrest
28-day survival
28 days post-cardiac arrest
Modified Rankin Scale (mRS) score.
Time Frame: 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.
28 days post-cardiac arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021PI170
  • 2023-505349-26-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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