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Cardiac arrest (CA) is a public health problem in industrialized countries. The prognosis of these patients remains poor with significant mortality and severe neurological sequelae in survivors.
The objective of the present study is to determine whether cyclosporine can improve patient clinical outcome after shockable CA. 520 patients with CA will be entered into a multicentre, randomized, placebo-controlled study. They will receive one single injection of cyclosporine (or placebo) prior to resuscitation. The incidence of the combined endpoint (mortality, irreversible brain damage informations such as bilateral abolition of N20 wave or absent motor response or extension to the nociceptive stimulation…) will be assessed 7 days after CA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine A | Experimental | Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation |
|
| Control | Placebo Comparator | Single intravenous bolus of placebo (2.5 mg/kg) at the onset of resuscitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation | Drug | cardio-pulmonary resuscitation usual care of cardiac arrest |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined incidence of all-cause mortality and irreversible brain damage status | the presence of irreversible brain damage is defined by the bilateral abolition of the N20 wave on somatosensory evoked potentials recordings or the absence of motor response or extension to painful stimuli on the Glasgow Coma Scale. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Argaud | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Cardiologique | Bron | France |
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| Single intravenous bolus of placebo at the onset of resuscitation | Drug | cardio-pulmonary resuscitation usual care of cardiac arrest |
|
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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