CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation

Study Overview
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Brief Summary
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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.

Official Title
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CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation

Conditions
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Shockable Out of Hospital Cardiac Arrest

Intervention / Treatment
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* Drug: Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
* Drug: Single intravenous bolus of placebo at the onset of resuscitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Witnessed out-of-hospital cardiac arrest Shockable cardiac rhythm at first medical contact (ventricular fibrillation, ventricular tachycardia) Exclusion Criteria: Evidence of trauma Evidence of pregnancy Duration of no flow more than 30 minutes Rapidly fatal underlying disease Allergy to cyclosporin A

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclosporine A<br>Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation | Drug: Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation<br>* cardio-pulmonary resuscitation usual care of cardiac arrest<br>|
| Placebo Comparator: Control<br>Single intravenous bolus of placebo (2.5 mg/kg) at the onset of resuscitation | Drug: Single intravenous bolus of placebo at the onset of resuscitation<br>* cardio-pulmonary resuscitation usual care of cardiac arrest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac arrest, Shockable, Cyclosporine