Impact of Low Dose Epinephrine in the Management of Out-of-hospital Cardiac Arrest on Neurological Outcome
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Epinephrine 0.5 mg intravenous bolus
DrugEpinephrine 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 intravenous bolus
DrugEpinephrine 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.
Treatment groups
4,336 Participants
are divided into 2 treatment groupsGroup A: Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary ResuscitationExperimental treatment 1 intervention
Group B: Epinephrine 1 mg IV bolus every 3-5 minutes during Cardio-Pulmonary ResuscitationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-daySecondary outcomes
1
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 resuscitation2
Vital status
Survival at hospital admission.
Time frame
Periprocedural period of cardiopulmonary resuscitation3
vital status
28-day survival
Time frame
28 days post-cardiac arrest4
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 arrestSponsors and contacts
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Source ClinicalTrials.gov
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