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Starting soon Phase 4

Epinephrine Versus Isoprenaline During Out-of-Hospital Cardiac Arrest With Asystole

NCT06473116 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 4
Started
2025-03
Last updated
2024-06-25

Condition(s) studied

Out-Of-Hospital Cardiac Arrest

Investigational drug(s) / intervention(s)

Isoprenaline Only Product →

Isoprenaline Only Product: Administration of intravenous isoprenaline of 600 mikrograms immediately after recognition of asystole in bystander-witnessed out-of-hospital cardiac arrest

Study summary

Background: During out-of-hospital cardiac arrest (OHCA), the patient presents with either a shockable or a non-shockable rhythm. Early cardiopulmonary resuscitation (CPR) and defibrillation of the shockable rhythm may increase chance of survival to more than 50%, however, if untreated, the heart rhythm will deteriorate to a non-shockable rhythm with dismal survival outcomes of 1-5%. Isoprenaline is a pro-arrhythmic drug used to treat bradycardia, and has a structural resemblance to epinephrine, which is the drug of choice during cardiac arrest with non-shockable rhythms.

Aims: To evaluate whether intravebous (IV) administration of isoprenaline increases the chance of return of spontaneous circulation (ROSC) to hospital arrival (main outcome) compared with IV epinephrine.

Study design: A randomized-controlled trial.

Setting: The study will be conducted in the Region of Southern Denmark, which has about 1.2 million inhabitants and an annual incidence of 1,200 OHCAs. The study will include bystander-witnessed patients with asystole at the arrival of the emergency medical services (EMS). Randomization will take place on arrival of the EMS, where the OHCA patients randomly will be assigned to receive an intravenous injection of isoprenaline (600 µg) or an intravenous injection of adrenaline (1 mg) in a 1:1 ratio. The study will include 1,178 OHCAs over a time period of about 3.5 years.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Witnessed out-of-hospital cardiac arrest * Age 18 years or more * Initial rhythm asystole at EMS arrival * Advanced life support initiated or continued by EMS personnel Exclusion Criteria: * Cardiac arrest caused by blunt trauma, penetrating trauma, or burn injury suspected to be the cause of the cardiac arrest * Cardiac arrest caused by drowning, hanging, strangulation, and foreign body airway obstruction * IV epinephrine already administered prior to EMS arrival * Prior enrollment in the trial * Known or apparent pregnancy * Cardiac arrest at nursing homes

Primary outcome measure(s)

  • Rate of Return of Spontaneous Circulation (ROSC) at hospital arrival — Up to 2 hours
    Arrival to hospital admission

Trial sites (1)

FacilityCityRegionStatus
Research Department of Cardiology Odense Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06473116 on ClinicalTrials.gov ↗ ← All trials in Denmark