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Cyclosporine A in Cardiac Arrest (CYRUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01595958
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : May 1, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The investigators hypothesised that cyclosporine A administration at the onset of cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore, could prevent the post cardiac arrest syndrome and improve outcomes.

Condition or disease Intervention/treatment Phase
Non Shockable Out of Hospital Cardiac Arrest Drug: Cyclosporine A Procedure: cardio-pulmonary resuscitation Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 796 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CYclosporine A in Non-shockable Out-of-hospital Cardiac Arrest ResUScitation
Study Start Date : June 2010
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cyclosporine A
Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
Drug: Cyclosporine A
Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
Procedure: cardio-pulmonary resuscitation
usual care of cardiac arrest
Active Comparator: Control
usual care of cardiac arrest
Procedure: cardio-pulmonary resuscitation
usual care of cardiac arrest


Outcome Measures

Primary Outcome Measures :
  1. Sequential Organ Failure Assessment score (SOFA) [ Time Frame: At 24 hours after hospital admission ]

Secondary Outcome Measures :
  1. Hospital admission with return of spontaneous circulation [ Time Frame: At 24 hours following admission, at day 28, at hospital discharge (an average time frame of 7 days) ]
  2. Survival [ Time Frame: At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days) ]
  3. Good cerebral outcome [ Time Frame: At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days) ]
    Glasgow Coma Scale and Cerebral Performance Categories

  4. All adverse events [ Time Frame: until hospital discharge (an average time frame of 7 days) ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Witnessed out-of-hospital cardiac arrest
  • Non shockable cardiac rhythm

Exclusion Criteria:

  • Evidence of trauma
  • Evidence of pregnancy
  • Duration of no flow more than 30 minutes
  • Rapidly fatal underlying disease
  • Allergy to cyclosporin A
Contacts and Locations

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): NCT01595958


Locations
France
Medical intensive care unit, Edouard Herriot Hospital
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Laurent ARGAUD, MD, PhD Groupement Hospitalier Edouard Herriot,69437 Lyon Cedex 03
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01595958     History of Changes
Other Study ID Numbers: 2009.571
2009-015725-37 ( EudraCT Number )
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014

Keywords provided by Hospices Civils de Lyon:
Cardiac arrest
heart arrest
cyclosporine A
post cardiac arrest syndrome
protective agent
multiple organ failure
mitochondrial permeability transition pore
mitochondria
cardio-pulmonary resuscitation
cardioprotection
ischemia reperfusion
postconditioning

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