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NCT Number: NCT07442071

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

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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Key information

Conditions

Out-Of-Hospital Cardiac Arrest (OHCA) Cardiovascular Diseases Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CH Annecy, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Vital status

    Time frame: Periprocedural period of cardiopulmonary resuscitation

    Survival at hospital admission.

  3. vital status

    Time frame: 28 days post-cardiac arrest

    28-day survival

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas Girerd, MD PhD

CONTACT

[email protected]

0033383157322

Tahar CHOUIHED, MD, PhD

CONTACT

[email protected]

0033383157322

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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.

Acronym: Low-EPI

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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