drugset / Trial / NCT06473116

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

NCT06473116

Phase 4 Not yet recruiting 1178 enrolled University of Southern Denmark Odense University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-03
Primary completion
2029-07
Completion
2029-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Isoproterenol Small molecule 600 ug Intravenous

Indications