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

Hospices Civils de Lyon

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Shockable Out of Hospital Cardiac Arrest

Interventions

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

cardio-pulmonary resuscitation usual care of cardiac arrest

Single intravenous bolus of placebo at the onset of resuscitationDRUG

cardio-pulmonary resuscitation usual care of cardiac arrest

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hopital Cardiologique

Bron, France

Outcomes

Primary Outcomes

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.

Time frame: 7 days

Data from ClinicalTrials.gov

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