CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation (CYRUS II)

Civil Hospices of Lyon

Status and phase: Withdrawn; Phase 3

Conditions: Shockable Out of Hospital Cardiac Arrest

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT02887807

2012-753

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Cyclosporine A

Experimental group

Description:

Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation

Treatment:

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

Control

Placebo Comparator group

Description:

Single intravenous bolus of placebo (2.5 mg/kg) at the onset of resuscitation

Treatment:

Drug: Single intravenous bolus of placebo at the onset of resuscitation