Evaluation of Low-Dose Epinephrine Versus Standard-Dose Epinephrine on Neurological Outcomes in Out-of-Hospital Cardiac Arrest: A Randomized, Double-Blind Trial

The primary objective of this study is to evaluate the impact of a low dose of epinephrine (0.5 mg bolus) compared to the standard dose (1 mg bolus) on 28-day survival with a favorable neurological outcome in patients experiencing out-of-hospital cardiac arrest managed by a Mobile Medical Team. Scope: 3, 5.

Secondary objectives include the comparison of the following outcomes between the two treatment groups:

• Return of spontaneous circulation (ROSC)
• Survival at hospital admission
• 28-day survival
• 28-day neurological status as assessed by the Modified Rankin Scale (mRS) score

The sponsor did not provide information regarding the total number of participants. The study population consists of patients experiencing out-of-hospital cardiac arrest. Eligible individuals include both males and females aged 18 years or older. Inclusion requires that the resuscitation is initiated by a Mobile Medical Team and that the subject is affiliated with a social security plan. This population is classified as vulnerable.

This multicenter, randomized, double-blind trial evaluates the impact of low-dose epinephrine on neurological outcomes following out-of-hospital cardiac arrest. The study compares the efficacy of a 0.5 mg bolus of epinephrine bitartrate against a 1 mg standard dose. The primary endpoint is 28-day survival with a favorable neurological function, defined as a Modified Rankin Scale score of 2 or less. Secondary endpoints include return of spontaneous circulation, survival at hospital admission, 28-day survival, and the use of the scale as a continuous variable. The research methodology involves a comparison between the test product and a comparator administered via intravenous bolus injection. The trial is expected to proceed through a recruitment period spanning from December 2025 to December 2029.

The experimental treatment consists of epinephrine bitartrate administered as a solution for injection. The specified dosage is 5 mg, delivered via intravenous bolus injection or intravenous infusion.

The comparator treatment involves epinephrine bitartrate in a solution for injection. The administered dosage is 10 mg via intravenous bolus.

The efficacy of the intervention will be evaluated using several predefined endpoints. The primary endpoint is 28-day survival with a favorable neurological outcome, which is defined as a Modified Rankin Scale (mRS) score of 2 or less at 28 days following out-of-hospital cardiac arrest.

Secondary endpoints include:

• Return of Spontaneous Circulation, determined through clinical assessment of signs of life, such as a palpable pulse or blood pressure generation, during cardiopulmonary resuscitation.
• Survival at hospital admission.
• 28-day survival rate.
• The mRS score analyzed as a continuous variable.