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

NCT06473116 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: EPISOTrial
• Study Type: interventional
• Target: 1,178
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Out-Of-Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Rate of Return of Spontaneous Circulation (ROSC) at hospital arrival

  Arrival to hospital admission

  Up to 2 hours

Secondary Outcomes (4)

• Rate of conversions from asystole to shockable rhythm

  Up to 1 hour

• Number of participants with favorable neurological outcome at hospital discharge

  Median hospital stay is about 24 days after out-of-hospital cardiac arrest

• TNumber of participants alive after 30 days

  At 30 days

• Number of participants who gain sustained return of spontaneous circulation

  20-50 minutes

Study Arms (2)

Intervention group

EXPERIMENTAL

Isoprenaline

Drug: Isoprenaline Only Product

Control group

ACTIVE COMPARATOR

Epinephrine (adrenaline)

Drug: Isoprenaline Only Product

Interventions

Isoprenaline Only Product DRUG

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

Also known as: isoproterenol

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator

Study Sites (1)

Research Department of Cardiology

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Isoproterenol

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 25, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Six months after the publication of the last results.
• Access Criteria: Appropriate approval of the study and methodologically sound proposals will be able to request the trial data by contacting the principal investigator and considered for data sharing.

Locations

DK (1)