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

Primary Purpose

Shockable Out of Hospital Cardiac Arrest

Status
Withdrawn
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
Single intravenous bolus of placebo at the onset of resuscitation
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shockable Out of Hospital Cardiac Arrest focused on measuring Cardiac arrest, Shockable, Cyclosporine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hopital Cardiologique

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cyclosporine A

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 18, 2016
Last Updated
March 13, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02887807
Brief Title
CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation
Acronym
CYRUS II
Official Title
CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shockable Out of Hospital Cardiac Arrest
Keywords
Cardiac arrest, Shockable, Cyclosporine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclosporine A
Arm Type
Experimental
Arm Description
Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Single intravenous bolus of placebo (2.5 mg/kg) at the onset of resuscitation
Intervention Type
Drug
Intervention Name(s)
Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
Intervention Description
cardio-pulmonary resuscitation usual care of cardiac arrest
Intervention Type
Drug
Intervention Name(s)
Single intravenous bolus of placebo at the onset of resuscitation
Intervention Description
cardio-pulmonary resuscitation usual care of cardiac arrest
Primary Outcome Measure Information:
Title
Combined incidence of all-cause mortality and irreversible brain damage status
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Argaud
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Cardiologique
City
Bron
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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