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

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ClinicalTrials.gov Identifier: NCT02887807
Recruitment Status : Not yet recruiting
First Posted : September 2, 2016
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.


Condition or disease Intervention/treatment Phase
Shockable Out of Hospital Cardiac Arrest 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 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation
Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cyclosporine A
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
cardio-pulmonary resuscitation usual care of cardiac arrest

Placebo Comparator: Control
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
cardio-pulmonary resuscitation usual care of cardiac arrest




Primary Outcome Measures :
  1. Combined incidence of all-cause mortality and irreversible brain damage status [ Time Frame: 7 days ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887807


Contacts
Contact: Laurent Argaud, MD 472110015 ext +33
Contact: Michel OVIZE 427856570 ext +33 michel.ovize@chu-lyon.fr

Locations
France
Hopital Cardiologique Not yet recruiting
Bron, France
Contact: Laurent Argaud         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Laurent Argaud Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02887807     History of Changes
Other Study ID Numbers: 2012-753
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospices Civils de Lyon:
Cardiac arrest
Shockable
Cyclosporine

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors