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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4,336
Epinephrine 0.5 mg/mL solution for injection, administered as a 0.5 mg intravenous bolus every 3 to 5 minutes during cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest. T
Epinephrine 1 mg/mL solution for injection, administered as a 1 mg intravenous bolus every 3 to 5 minutes during cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest.
CH Annecy
Annecy, France
Centre hospitalier de la Côte Basque
Bayonne, France
CHU Besancon
Besançon, France
CHU Brest
Brest, France
CHU Colmar
Colmar, France
CH SUD Francilien
Corbeil-Essonnes, France
Brigade de Sapeurs-Pompiers de Paris
Courbevoie, France
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, France
Hospices Civils De Lyon
Lyon, France
CHU Montpellier
Montpellier, France
...and 16 more locations
Modified Rankin Scale (mRS) score
The mRS score is a validated score measuring neurologic outcomes after cardio-pulmonary resuscitation (CPR) : * mRS 0. No symptoms. * mRS 1. No significant disability. Able to perform all usual activities, despite some symptoms. * mRS 2. Slight disability. Independent but unable to perform usual activities (work, sports, leisure). mRS 3. Moderate disability. Requires assistance, but able to walk alone. * mRS 4. Moderately severe disability. Walking assistance and daily living activities not possible. mRS 5. Major disability. Bedridden, incontinent and requires constant nursing care and attention. * mRS 6. Death.
Time frame: 28-day
Return of Spontaneous Circulation (ROSC).
Return of Spontaneous Circulation (ROSC) during cardiopulmonary resuscitation, defined as clinical signs of life including palpable pulse or blood pressure.
Time frame: Periprocedural period of cardiopulmonary resuscitation
Vital status
Survival at hospital admission.
Time frame: Periprocedural period of cardiopulmonary resuscitation
vital status
28-day survival
Time frame: 28 days post-cardiac arrest
Modified Rankin Scale (mRS) score.
Modified Rankin Scale (mRS) score used as a continuous variable (in contrast with the use of the mRS scale in the primary outcome). The mRS score is a validated score measuring neurologic outcomes after cardio-pulmonary resuscitation (CPR) : * mRS 0. No symptoms. * mRS 1. No significant disability. Able to perform all usual activities, despite some symptoms. * mRS 2. Slight disability. Independent but unable to perform usual activities (work, sports, leisure). mRS 3. Moderate disability. Requires assistance, but able to walk alone. * mRS 4. Moderately severe disability. Walking assistance and/or daily living activities not possible. mRS 5. Major disability. Bedridden, incontinent and requires constant nursing care and attention. * mRS 6. Death. The mRS score will be assessed 28 days after cardiac arrest.
Time frame: 28 days post-cardiac arrest
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