Out-of-hospital Cardiac Arrest (OHCA)Phase 3Low-EPINCT07442071
Impact of Low Dose Epinephrine in the Management of Out-of-hospital Cardiac Arrest on Neurological Outcome
A Phase 3 study testing Epinephrine 0.5 mg intravenous bolus and Epinephrine 1 mg intravenous bolus in people with Out-of-hospital Cardiac Arrest (OHCA), run by Central Hospital, Nancy, France at 26 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-hospital Cardiac Arrest (OHCA)
- What is being tested?
- Epinephrine 0.5 mg intravenous bolus and Epinephrine 1 mg intravenous bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,336 participants
- Where
- 26 sitesFrance
- Study dates
- Jun 2026to Jul 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
France26 sites
CH Annecy
Annecy
Hugo SCHMIT, MD PHD, +33 4 50 63 63 63, hschmit@ch-annecygenevois.fr
Hugo SCHMIT, MD PhD
Centre hospitalier de la Côte Basque
Bayonne
Pereira Xavier, MD, +33 5 59 44 35 35, xpereira@ch-cotebasque.fr
Xavier Pereira, MD
CHU Besancon
Besançon
Abdo KHOURY, MD, 0033381668836, akhoury@chu-besancon.fr
Abdo KHOURY, MD
CHU Brest
Brest
Adrien Basset, MD, +33 2 98 22 33 33, adrien.basset@chu-brest.fr
Adrien Basset, MD
CHU Colmar
Colmar
Yannick GOTTWALLES, MD, +33 3 89 12 40 00, yannick.GOTTWALLES@ch-colmar.fr
Yannick GOTTWALLES, MD
CH SUD Francilien
Corbeil-Essonnes
Romain BARDELAY, MD, 0033161696169, secretariat@samu91.org
Romain BARDELAY, MD
Brigade de Sapeurs-Pompiers de Paris
Courbevoie
Simon-Pierre CORCOSTEGUI, MD, 0033149047425, simon-pierre.corcostegui@pompiersparis.fr
Simon-Pierre CORCOSTEGUI, MD
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche
Nicolas SEGOND, MD, 0033476767575, nsegond@chu.grenoble.fr
Nicolas SEGOND, MD
Hospices Civils De Lyon
Lyon
CHU Montpellier
Montpellier
Thomas SANCHEZ, MD, +33 4 67 33 67 33, thomas-sanchez@chu-montpellier.fr
Thomas Sanchez, MD
CHRU Nancy
Nancy
Tahar CHOUIHED, MD, PhD, 0033383858585, T.CHOUIHEDMAHJOUB@chru-nancy.fr
Tahar CHOUIHED, MD, PhD
Centre Hospitalier Universitaire De Nantes
Nantes
François JAVAUDIN, MD, francois.javaudin@chu-nantes.fr
François JAVAUDIN, MD
CHU Nice
Nice
Julie CONTENTI, MD PHD, +33 4 92 03 77 77, contenti.j@chu-nice.fr
Julie Contenti, MD PhD
CHU Nimes
Nîmes
Fabien COISY, MD, +33 4 66 68 68 68, fabien.coisy@chu-nimes.fr
Fabien COISY, MD
AP-HP Hôpital Necker
Paris
Alice HUTIN, MD, +33 1 44 49 40 00, alice.hutin@aphp.fr
Alice HUTIN, MD
Hopital Beaujon
Paris
Bénédicte DOUAY, MD, +33 1 40 87 50 00, benedicte.douay@aphp.fr
Benedicte Douay, MD
hôpital Lariboisière
Paris
Anthony CHAUVIN, MD PHD, +33 1 49 95 65 65, anthony.chauvin@aphp.fr
clementine.cassard@aphp.fr
La Pitié Salpêtrière
Paris
Clémentine Cassard, MD, +33 1 42 16 00 00
clementine.cassard@aphp.fr
Raymond Poincaré Hospital
Paris
Armelle Severin, MD, +33 1 47 10 79 00, armelle.severin@aphp.fr
Armelle Severin, MD
CHU Poitiers
Poitiers
Nicolas MARJANOVIC, MD, +33 5 49 44 44 44, nicolas.MARJANOVIC@chu-poitiers.fr
Nicolas MARJANOVIC, MD PhD
Centre Hospitalier Universitaire Reims
Reims
Stéphane GENNAI, MD, 0033326787878, s.gennai@chu-reims.fr
Stéphane GENNAI, MD
CHU Rennes
Rennes
Nicolas PESCHANSKI, MD PHD, +33 2 99 28 43 21, nicolas.PESCHANSKI@chru-rennes.fr
Nicolas PESCHANSKI, MD PhD
CHU Rouen
Rouen
Marie OZANNE, MD, +33 2 32 88 89 90, m.ozanne@chu-rouen.fr
Marie Ozanne, MD
Centre hospitalier Annecy Genevois Site Julien en GENEVOIS
Saint-Julien-en-Genevois
Arnaud RELLY, MD, 003345063601, arelly@ch-annecygenevois.fr
Arnaud RELLY, MD
Centre Hospitalier Universitaire De Toulouse
Toulouse
Bertand GUIHARD, MD, 0033561772233, samu.secretariat@chu-toulouse.fr
Bertrand GUIHARD, MD
CHU Tours
Tours
Alexandre JEZIORNY, MD, +33 2 47 47 47 47, a.JEZIORNY@chu-tours.fr
Alexandre JEZIORNY, MD
About this study
Official title: 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.
- Conditions
- Out-of-hospital Cardiac Arrest (OHCA)
- Being tested
- Epinephrine 0.5 mg intravenous bolus, Epinephrine 1 mg intravenous bolus
- Keywords
- Epinephrine,, Cardiac Arrest, Neurological Outcome, Emergency Medicine
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine 0.5 mg intravenous bolusDrug
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 bolusDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Epinephrine 1 mg intravenous bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28-day
Secondary outcomes (4)
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.
Measured: Periprocedural period of cardiopulmonary resuscitation
Vital status
Survival at hospital admission.
Measured: Periprocedural period of cardiopulmonary resuscitation
vital status
28-day survival
Measured: 28 days post-cardiac arrest
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.
Measured: 28 days post-cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-hospital Cardiac Arrest (OHCA)Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHOUIHED Tahar, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442071
- Sponsor's protocol ID
- 2021PI170
- Other IDs
- 2023-505349-26-00, 2023
- Acronym
- Low-EPI
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low Dose Epinephrine in the Management of Out-of-hospital Cardiac Arrest on Neurological Outcome: A Multicenter Randomized and Double-blind Trial.
- ClinicalTrials.gov ID
- NCT07442071
- Acronym / sponsor ID
- Low-EPI / 2021PI170
- Conditions
- Out-of-hospital Cardiac Arrest (OHCA)
- Keywords
- Epinephrine,, Cardiac Arrest, Neurological Outcome, Emergency Medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,336 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation | Experimental | Drug: 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 Resuscitation | Active comparator | Drug: Epinephrine 1 mg intravenous bolusEpinephrine 1 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epinephrine 0.5 mg intravenous bolusEpinephrine 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 | Drug | Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation |
| Epinephrine 1 mg intravenous bolusEpinephrine 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. | Drug | Epinephrine 1 mg IV bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation |
Primary outcome
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.
4 secondary outcomes
Return of Spontaneous Circulation (ROSC).
Time frame: Periprocedural period of cardiopulmonary resuscitation
Vital status
Time frame: Periprocedural period of cardiopulmonary resuscitation
vital status
Time frame: 28 days post-cardiac arrest
Modified Rankin Scale (mRS) score.
Time frame: 28 days post-cardiac arrest
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
Related trials for Out-of-hospital Cardiac Arrest (OHCA)
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Recruiting
Mean Arterial Pressure After Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-of-hospital Cardiac Arrest (OHCA)
Recruiting
Ventilation Performance and Feedback Simulation Trial
Out-of-hospital Cardiac Arrest (OHCA)
Recruiting
Does Increasing the Compression Pause From 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?
Cardiac Arrest (CA)
Active, not recruitingObservational study
Frontal EEG in OHCA Feasibility Study
Out-Of-Hospital Cardiac Arrest, BIS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epinephrine 0.5 mg intravenous bolus and Epinephrine 1 mg intravenous bolus in people with Out-of-hospital Cardiac Arrest (OHCA), run by Central Hospital, Nancy, France at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tahar CHOUIHED, MD, PhD (0033383157322, T.CHOUIHEDMAHJOUB@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) score (time frame: 28-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.