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

Shockable Out of Hospital Cardiac Arrest Clinical Trial

— CYRUS II  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02887807
• Other study ID #: 2012-753
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: January 2019

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Shockable Out of Hospital Cardiac Arrest

Intervention

Drug:
• Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
cardio-pulmonary resuscitation usual care of cardiac arrest
• Single intravenous bolus of placebo at the onset of resuscitation
cardio-pulmonary resuscitation usual care of cardiac arrest

Locations

Country	Name	City	State
France	Hopital Cardiologique	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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