A study comparing epinephrine and isoprenaline in patients with out-of-hospital cardiac arrest who have non-shockable heart rhythm

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What is this study about?

This study focuses on treating patients with cardiac arrest, specifically when the heart has stopped beating in a pattern that cannot be treated with an electrical shock. The research compares two medications: isoprenaline and epinephrine (also known as adrenaline). These medications are given through direct injection into a vein during attempts to restart the heart.

The purpose is to find out if isoprenaline is more effective than epinephrine at achieving sustained heartbeat restoration in patients whose hearts have stopped beating outside of a hospital setting. Both medications are given as liquid solutions that are injected into the bloodstream during resuscitation efforts.

During the study, emergency medical service personnel will give either isoprenaline or epinephrine to patients experiencing cardiac arrest. The maximum daily dose of isoprenaline that may be given is 2.4 milligrams, while the maximum daily dose of epinephrine is 4 milligrams. The treatment period lasts for one day, during which medical professionals will monitor how the patient’s heart responds to the medication.

1 Initial assessment

Your eligibility for the study will be assessed during an out-of-hospital cardiac arrest event

The medical team will confirm that you are 18 years or older and have a non-shockable heart rhythm (a specific type of heart activity pattern)

The cardiac arrest must be witnessed by bystanders or emergency medical personnel

2 Treatment administration

You will receive one of two medications through an intravenous injection (directly into a vein):

Either epinephrine (also known as adrenaline) as an injection solution

Or isoprenaline hydrochloride as an infusion solution

3 Immediate monitoring

The medical team will monitor your heart’s response to the medication for at least 20 minutes

They will check if your heart returns to normal functioning (return of spontaneous circulation)

They will also monitor if your heart rhythm changes from non-shockable to shockable pattern

4 Hospital care

If your condition stabilizes, you will be transported to the hospital

The medical team will continue monitoring your response to treatment

Your neurological condition will be evaluated during your hospital stay

5 Follow-up

Your health status will be monitored for 30 days after the event

The medical team will assess your overall recovery and survival

Who Can Join the Study?

Must be 18 years or older
Must have experienced a cardiac arrest outside of hospital that was witnessed by bystanders and/or emergency medical personnel
Must have a non-shockable heart rhythm when first examined (this means the heart has either stopped completely – known as asystole, or is showing some electrical activity without effective pumping – known as PEA)
Must be receiving or about to receive advanced life support treatment from emergency medical service (EMS) personnel (this includes procedures like CPR, medication administration, and airway management)
Can be either male or female

Who Cannot Join the Study?

Patient under 18 years old (since age ranges indicate adult population only)
Patients with shockable heart rhythm (a heart rhythm that can be treated with an electric shock from a defibrillator)
Cardiac arrest not occurring in out-of-hospital setting
Known allergy or hypersensitivity to isoprenaline or epinephrine (medications used in the study)
Pregnancy or suspected pregnancy
Patients who have already received epinephrine or isoprenaline during the current cardiac arrest event
Traumatic cause of cardiac arrest
Presence of a Do Not Resuscitate (DNR) order (a legal order indicating the patient does not want emergency lifesaving treatment)
Patients who have already achieved return of spontaneous circulation
Family or legal representative refusing participation in the study

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Odense University Hospital	Odense	Denmark
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.06.2025

Trial locations

Investigated drugs:

Epinephrine is a medication that helps the heart beat stronger and faster during cardiac arrest. It works by constricting blood vessels and increasing heart rate, which helps maintain blood flow to vital organs during emergencies. It is commonly used as the standard medication in cardiac arrest situations.

Isoprenaline is a medication that stimulates the heart to beat faster and stronger, similar to epinephrine, but works in a slightly different way. It primarily affects the heart’s rhythm and strength of contractions without causing as much blood vessel constriction. It is being studied as an alternative to epinephrine in treating cardiac arrest patients who have rhythms that cannot be treated with electrical shock (non-shockable rhythms).

Investigated diseases:

Cardiac arrest

Cardiac Arrest – A sudden loss of heart function where the heart stops beating effectively and pumping blood to the body. During cardiac arrest, blood flow to vital organs ceases abruptly, particularly affecting the brain and other crucial systems. The condition can occur due to various underlying heart problems, including electrical disturbances in heart rhythm. Cardiac arrest can present with two main types of heart rhythms: shockable and non-shockable. The condition develops suddenly and without warning, leading to immediate loss of consciousness. The person affected will not be breathing normally and will be unresponsive.

Trial ID:

2024-516074-29-00

NCT ID:

NCT06473116

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study comparing epinephrine and isoprenaline in patients with out-of-hospital cardiac arrest who have non-shockable heart rhythm

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?