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Clinical Trials in the EU / 2023-505349-26-00
Authorised Phase III

Impact of low dose epinephrine in the management of out-of-hospital cardiac arrest on neurological outcome: A multicenter randomized and double-blind trial (Low-EPI Study)

2023-505349-26-00 · tracked via the Priya Life Science EU tracker
Sponsor
CHRU De Nancy
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Cardiovascular Diseases
Decision date
08/10/2025
Enrollment target
4336
Sites
France

Condition studied

Out-of-hospital cardiac arrest.

Investigational medicinal product(s)

ADRENALINE RENAUDIN 050 mg/mlsolution injectableADRENALINE RENAUDIN 1 mg/mlsolution injectable en ampoule

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

28-day survival with a favorable neurological function defined as a Modified Rankin Scale (mRS) of score 2 or less at 28-days.

Endpoint detail

The secondary endpoints are: • Return of Spontaneous Circulation, assessed during cardiopulmonary resuscitation (CPR) and defined as a clinical assessment that shows signs of life, including palpable pulse or generating a blood pressure. • Survival at hospital admission. • 28-day survival. • Modified Rankin Scale (mRS) score used as a continuous variable (in contrast with the use of the mRS scale in the primary outcome).

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2023-505349-26-00 on CTIS ↗ ← All trials in the EU