Cyclosporine A in Cardiac Arrest

Non Shockable Out of Hospital Cardiac Arrest Clinical Trial

— CYRUS  

Official title:

CYclosporine A in Non-shockable Out-of-hospital Cardiac Arrest ResUScitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595958
• Other study ID #: 2009.571
• Secondary ID: 2009-015725-37
• Status: Completed
• Phase: Phase 3
• First received: April 30, 2012
• Last updated: April 30, 2014
• Start date: June 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2014
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 796
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Medical intensive care unit, Edouard Herriot Hospital	Lyon

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	Sequential Organ Failure Assessment score (SOFA)		At 24 hours after hospital admission	No
Secondary	Hospital admission with return of spontaneous circulation		At 24 hours following admission, at day 28, at hospital discharge (an average time frame of 7 days)	No
Secondary	Survival		At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)	No
Secondary	Good cerebral outcome	Glasgow Coma Scale and Cerebral Performance Categories	At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)	No
Secondary	All adverse events		until hospital discharge (an average time frame of 7 days)	Yes