Non Shockable Out of Hospital Cardiac Arrest
Conditions
Keywords
Cardiac arrest, heart arrest, cyclosporine A, post cardiac arrest syndrome, protective agent, multiple organ failure, mitochondrial permeability transition pore, mitochondria, cardio-pulmonary resuscitation, cardioprotection, ischemia reperfusion, postconditioning
Brief summary
The investigators hypothesised that cyclosporine A administration at the onset of cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore, could prevent the post cardiac arrest syndrome and improve outcomes.
Interventions
DRUGCyclosporine A
Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
PROCEDUREcardio-pulmonary resuscitation
usual care of cardiac arrest
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Witnessed out-of-hospital cardiac arrest * Non shockable cardiac rhythm
Exclusion criteria
* Evidence of trauma * Evidence of pregnancy * Duration of no flow more than 30 minutes * Rapidly fatal underlying disease * Allergy to cyclosporin A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sequential Organ Failure Assessment score (SOFA) | At 24 hours after hospital admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital admission with return of spontaneous circulation | At 24 hours following admission, at day 28, at hospital discharge (an average time frame of 7 days) | — |
| Survival | At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days) | — |
| Good cerebral outcome | At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days) | Glasgow Coma Scale and Cerebral Performance Categories |
| All adverse events | until hospital discharge (an average time frame of 7 days) | — |
Countries
France
Outcome results
None listed