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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)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505349-26-00
Acronym
2021PI170
Enrollment
4336
Registered
2025-10-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Out-of-hospital cardiac arrest.

Brief summary

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

Detailed description

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).

Interventions

DRUGADRENALINE RENAUDIN 0
DRUGsolution injectable
DRUGADRENALINE RENAUDIN 1 mg/ml

Sponsors

CHRU De Nancy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
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).

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026