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Study comparing low-dose versus standard-dose epinephrine for better brain recovery in patients with out-of-hospital cardiac arrest

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients who experience out-of-hospital cardiac arrest, a serious medical emergency that occurs when the heart suddenly stops beating outside of a hospital setting. The research examines the use of epinephrine, also known as adrenaline, which is a medication commonly used during cardiac emergencies to help restart the heart.

The purpose of this study is to compare two different doses of epinephrine in treating cardiac arrest patients. The study will test whether a lower dose (0.5 mg) works better than the standard dose (1 mg) in helping patients survive with good brain function. The medication will be given as a solution for injection through a vein during emergency treatment by medical teams.

During the study, patients will be randomly assigned to receive either the lower or standard dose of epinephrine. Neither the patients nor the medical team will know which dose is being given. The treatment will be provided as part of the emergency care when medical teams arrive to help someone experiencing cardiac arrest. The study will monitor how well patients recover over 28 days after their cardiac arrest.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Medical team assesses the out-of-hospital cardiac arrest situation

    Verification of basic eligibility: age 18 or older and presence of social security coverage

    Confirmation that the cardiac arrest is medical in nature, not due to trauma or other causes

  2. Step 2

    Emergency medication administration

    You will receive either:

    - A low dose of 0.5 mg epinephrine through intravenous injection, or

    - A standard dose of 1.0 mg epinephrine through intravenous injection

    The type of dose is randomly assigned and neither you nor the medical team will know which dose is being used

  3. Step 3

    Immediate monitoring

    Medical team checks for return of spontaneous circulation (return of pulse and blood pressure)

    Continued monitoring during transport to hospital if circulation returns

  4. Step 4

    Hospital admission assessment

    Documentation of survival status upon hospital arrival

    Initial medical evaluation and care at the hospital

  5. Step 5

    28-day follow-up period

    Assessment of survival status throughout the 28-day period

    Evaluation of brain function using the Modified Rankin Scale (a measure of disability level)

    Final assessment of recovery and neurological function at day 28

Who can join the trial?

6 criteria

  • Must be at least 18 years old
  • Can be either male or female
  • Must have experienced a cardiac arrest (when heart suddenly stops beating) outside of a hospital setting
  • The cardiac arrest must be due to medical causes
  • Must be receiving resuscitation efforts from the Mobile Medical Team (emergency medical services)
  • Must have active social security coverage or be a beneficiary of a social security plan

Who cannot join the trial?

12 criteria

  • Age under 18 years old
  • Pregnant women
  • Patients with a Do Not Resuscitate (DNR) order - this means they have previously stated they do not wish to receive resuscitation
  • Patients with traumatic cardiac arrest - when the heart stops due to physical injury
  • Patients with hypothermic cardiac arrest - when the heart stops due to very low body temperature
  • Patients who have already received epinephrine (adrenaline) before the arrival of the medical team
  • Patients whose cardiac arrest was not witnessed by anyone
  • Patients who did not receive immediate cardiopulmonary resuscitation (CPR) - chest compressions and rescue breaths
  • Patients with terminal illness
  • Patients participating in other clinical trials
  • Patients who cannot be followed up for 28 days after the cardiac arrest
  • Patients whose family members refuse consent for participation
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Investigated drugs

Epinephrine (also known as adrenaline) is a medication used during cardiac arrest to help restart the heart. It works by increasing blood pressure and heart contrraction strength. In this trial, researchers are studying how different amounts of epinephrine might affect brain function in patients who experience cardiac arrest outside of the hospital. This medication is typically given through an injection directly into the bloodstream by emergency medical personnel when someone's heart stops beating.

What is already known about the treatment

Epinephrine - A critical emergency medication administered through intravenous injection during cardiac arrest situations, available in different dosage forms including 0.5 mg and 1 mg bolus preparations. This naturally occurring hormone, also known as adrenaline, works by stimulating heart muscle contractions, increasing blood pressure, and improving blood flow to vital organs through its action on alpha and beta-adrenergic receptors. Currently widely used as a first-line treatment in advanced cardiac life support protocols for out-of-hospital cardiac arrest, epinephrine's role in emergency medicine is well-established through extensive clinical research and practical application, though optimal dosing strategies continue to be studied to balance survival benefits with neurological outcomes.

Investigated diseases

Out-of-hospital cardiac arrest - A sudden loss of heart function that occurs outside of a hospital setting. It happens when the heart's electrical system malfunctions and the heart stops beating effectively, causing the person to lose consciousness and stop breathing normally. During cardiac arrest, blood flow to vital organs ceases, particularly affecting the brain and other critical systems. The condition develops suddenly and requires immediate emergency response. The heart's normal rhythm can be disrupted by various underlying causes, including heart disease, electrical disturbances, or other medical conditions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505349-26-00Protocol code2021PI170Estimated enrolment4 336 patientsSponsorCHRU De Nancy

sourced from the EU Clinical Trials Register and site verification

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