Impact of Low Dose Epinephrine in the Management of Out-of-hospital Cardiac Arrest on Neurological Outcome (Low-EPI)

Central Hospital, Nancy, France

Status and phase: Not yet enrolling; Phase 3

Conditions: Out-of-hospital Cardiac Arrest (OHCA)

Treatments: Drug: Epinephrine 0.5 mg intravenous bolus; Drug: Epinephrine 1 mg intravenous bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT07442071

2021PI170

2023-505349-26-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

This study will test whether a lower dose of epinephrine (0.5 mg) given during emergency treatment for out-of-hospital cardiac arrest helps more patients survive with good brain function, compared to the standard dose (1 mg). Adults who experience cardiac arrest outside the hospital and are treated by emergency medical teams will be randomly assigned to receive either the low dose or the standard dose of epinephrine. The study will compare survival and neurological outcomes between the two groups over 28 days.

Enrollment: 4,336 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Male or female, aged ≥18 years. Out-of-hospital cardiac arrest for which resuscitation is decided by the SMUR team.

Medical Out-of-hospital cardiac arrest. Affiliated with or beneficiary of a social security plan

Exclusion criteria

• Non-medical Out-of-hospital cardiac arrest (traumatic, drownings, electrocution, asphyxia, overdose, unknown cause).

• Out-of-hospital cardiac arrest without advanced life support (Do Not Attempt Resuscitation order, body finding, the decision not to attempt advanced life support is at the physician's discretion).

  • Pregnant women, birthing or breastfeeding mothers
  • Adults under legal protection measure (such as guardianship, conservatorship)
  • Individuals deprived of liberty due to judicial or administrative decision

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

4,336 participants in 2 patient groups

Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation

Experimental group

Description:

Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation

Treatment:

Drug: Epinephrine 0.5 mg intravenous bolus

Epinephrine 1 mg IV bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation

Active Comparator group

Description:

Epinephrine 1 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation

Treatment:

Drug: Epinephrine 1 mg intravenous bolus