Epinephrine Versus Isoprenaline During Out-of-Hospital Cardiac Arrest With Asystole
NCT Number: NCT06473116
Acronym: EPISO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Out-Of-Hospital Cardiac Arrest
Interventions: DRUG: Isoprenaline Only Product
Sponsor: University of Southern Denmark
Collaborators: Odense University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1178
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-03
Completion Date: 2029-07
Locations: Research Department of Cardiology, Odense, 5000, Denmark

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.

Primary Outcome Measures: Rate of Return of Spontaneous Circulation (ROSC) at hospital arrival, Arrival to hospital admission, Up to 2 hours
Secondary Outcome Measures: Rate of conversions from asystole to shockable rhythm, The conversion from asystole to either pulseless ventricular tachycardia or ventricular fibrillation during cardiac arrest resuscitation, Up to 1 hour|Number of participants with favorable neurological outcome at hospital discharge, The modified Rankin Scale (mRS) is ranked from 0 to 6 and defined the following way: A score of 0) represents no symptoms; 1) no significant disability; 2) slight disability; 3) moderate disability; 4) moderately severe disability; 5) severe disability and 6) death. Favorable neurological outcome is defined as mRS score of 0-3., Median hospital stay is about 24 days after out-of-hospital cardiac arrest|TNumber of participants alive after 30 days, Survival at 30 days after the out-of-hospital cardiac arrest, At 30 days|Number of participants who gain sustained return of spontaneous circulation, The patient achieved sustained return of spontaneous circulation (ROSC), defined as ROSC of at least 20 minutes after the cardiac arrest. ROSC is defined as the resumption of a sustained heart rhythm that perfuses the body after cardiac arrest., 20-50 minutes