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Cyclosporine A in Cardiac Arrest (CYRUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01595958
First received: April 30, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Non Shockable Out of Hospital Cardiac Arrest
Drug: Cyclosporine A
Procedure: cardio-pulmonary resuscitation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CYclosporine A in Non-shockable Out-of-hospital Cardiac Arrest ResUScitation

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Sequential Organ Failure Assessment score (SOFA) [ Time Frame: At 24 hours after hospital admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days) ] [ Designated as safety issue: No ]
  • Good cerebral outcome [ Time Frame: At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days) ] [ Designated as safety issue: No ]
    Glasgow Coma Scale and Cerebral Performance Categories

  • All adverse events [ Time Frame: until hospital discharge (an average time frame of 7 days) ] [ Designated as safety issue: Yes ]

Enrollment: 796
Study Start Date: June 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01595958     History of Changes
Other Study ID Numbers: 2009.571, 2009-015725-37
Study First Received: April 30, 2012
Last Updated: April 30, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Cardiovascular Diseases
Heart Diseases
Cyclosporine
Cyclosporins
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014