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Study of Isoprenaline and Epinephrine Treatment for Patients with Out-of-Hospital Cardiac Arrest with Non-Shockable Rhythm

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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 treating patients with cardiac arrest, specifically when the heart stops beating in a pattern that cannot be treated with an electric shock. The research examines whether combining two medications - isoprenaline and epinephrine - works better than using epinephrine alone when treating people whose hearts have stopped beating outside of a hospital.

The treatment involves giving medications through an intravenous bolus (a quick injection into a vein). Some patients will receive both isoprenaline and epinephrine, while others will receive epinephrine and a placebo. The study aims to determine if the combination of these medications can improve the chances of restarting the heart and maintaining its rhythm.

During the study, medical professionals will administer these treatments as part of standard emergency care procedures when they attend to people experiencing cardiac arrest outside of the hospital. The maximum dose of isoprenaline that may be given is 1600 micrograms per day. This research focuses specifically on cases where the heart has stopped in a way that cannot be treated with a defibrillator (the device that delivers electric shocks to the heart).

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Medical personnel will confirm that you are experiencing a cardiac arrest with a non-shockable heart rhythm.

    The medical team will verify that you are at least 18 years old and that the cardiac arrest was witnessed by bystanders or emergency medical personnel.

  2. Step 2

    Advanced life support

    Emergency medical service personnel will begin or continue advanced life support procedures.

    You will receive standard emergency care including chest compressions and breathing support.

  3. Step 3

    Medication administration

    You will receive either a combination of isoprenaline and epinephrine or epinephrine alone through an intravenous injection (directly into a vein).

    The medical team will monitor your heart rhythm for any changes, particularly looking for the return of normal heart function.

  4. Step 4

    Immediate outcome assessment

    The medical team will monitor for return of spontaneous circulation (restoration of normal heart function) for at least 20 minutes.

    If heart function returns, you will be transported to the hospital for continued care.

  5. Step 5

    Hospital care and monitoring

    Upon arrival at the hospital, the medical team will continue to monitor your condition.

    Your neurological function will be assessed during your hospital stay.

  6. Step 6

    Follow-up assessments

    Your condition will be evaluated at hospital discharge.

    Additional assessments will occur at 30 days and 90 days after the event to monitor your recovery and neurological function.

Who can join the trial?

8 criteria

  • Patient must be an adult (18 years or older)
  • The cardiac arrest must be witnessed by bystanders or emergency medical personnel
  • Patient must have a non-shockable heart rhythm (This means the heart is not in a rhythm that can be treated with an electrical shock)
  • The cardiac arrest must occur outside of the hospital
  • Patient must be receiving advanced life support treatment (specialized emergency care) from emergency medical service personnel
  • Both men and women can participate in the study
  • Patient must have either:
    • PEA (Pulseless Electrical Activity - when the heart shows electrical activity but is not pumping effectively) or
    • Asystole (complete absence of electrical activity in the heart)

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 75 years
  • Pregnant women
  • Known allergy to epinephrine (a medication that stimulates heart function) or isoprenaline (a medication that increases heart rate)
  • Traumatic cause of cardiac arrest (injury-related heart stoppage)
  • Presence of a Do Not Resuscitate order (written instructions not to perform CPR)
  • Cardiac arrest witnessed by emergency medical services
  • Previous administration of epinephrine during the current cardiac arrest
  • Cardiac arrest occurring in a healthcare facility
  • Known terminal illness (end-stage disease)
  • Participation in another clinical trial within the past 30 days
  • Cardiac arrest due to drowning, drug overdose, or electrocution
  • Presence of an implanted cardiac defibrillator or pacemaker
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Investigated drugs

  • Isoprenaline

    is a medication that helps increase heart rate and make the heart beat stronger. It works by stimulating certain receptors in the heart, which can help improve blood circulation during cardiac emergencies. It is used in this trial to help patients experiencing cardiac arrest.

  • Epinephrine

    , also known as adrenaline, is a medication commonly used in emergency situations, particularly during cardiac arrest. It works by constricting blood vessels and stimulating the heart, which can help restore normal heart rhythm and blood circulation. It is a standard treatment for cardiac arrest and is being studied both alone and in combination with isoprenaline.

What is already known about the treatment

  • Epinephrine

    A naturally occurring and synthetically produced hormone and neurotransmitter administered through injection in emergency situations, particularly during cardiac arrest. This medication works by stimulating both alpha and beta-adrenergic receptors, causing blood vessel constriction, increased heart rate, and improved cardiac output, making it a crucial first-line treatment in resuscitation protocols. It belongs to the class of medications called sympathomimetic agents and has been well-established in medical literature as a standard treatment for cardiac arrest.

  • Isoprenaline

    A synthetic sympathomimetic medication administered through injection that primarily stimulates beta-adrenergic receptors in the heart, leading to increased heart rate and cardiac output. This medication is used in the treatment of various cardiac conditions, including heart block and cardiac arrest, and works by mimicking the effects of natural adrenaline but with more selective action on heart tissue. It belongs to the beta-adrenergic agonist class of medications and is being studied in combination with epinephrine for potentially improved outcomes in cardiac arrest situations.

Investigated diseases

Cardiac Arrest - A sudden loss of heart function where the heart stops pumping blood effectively through the body. During cardiac arrest, the heart's electrical system malfunctions, causing the heart to stop beating properly. This condition can occur due to various underlying heart problems or external factors. The heart's pumping action becomes chaotic or ceases altogether, leading to a rapid loss of blood circulation. Without immediate intervention, cardiac arrest causes unconsciousness within seconds. Oxygen deprivation affects vital organs, particularly the brain, which begins to suffer damage within minutes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516074-29-01Estimated enrolment1 178 patientsSponsorOdense University Hospital

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