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Cyclosporine A in Cardiac Arrest (CYRUS)

Primary Purpose

Non Shockable Out of Hospital Cardiac Arrest

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Cyclosporine A
cardio-pulmonary resuscitation
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

  • Medical intensive care unit, Edouard Herriot Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cyclosporine A

Control

Arm Description

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

usual care of cardiac arrest

Outcomes

Primary Outcome Measures

Sequential Organ Failure Assessment score (SOFA)

Secondary Outcome Measures

Hospital admission with return of spontaneous circulation
Survival
Good cerebral outcome
Glasgow Coma Scale and Cerebral Performance Categories
All adverse events

Full Information

First Posted
April 30, 2012
Last Updated
April 30, 2014
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01595958
Brief Title
Cyclosporine A in Cardiac Arrest
Acronym
CYRUS
Official Title
CYclosporine A in Non-shockable Out-of-hospital Cardiac Arrest ResUScitation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
796 (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
Active Comparator
Arm Description
usual care of cardiac arrest
Intervention Type
Drug
Intervention Name(s)
Cyclosporine A
Intervention Description
Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
Intervention Type
Procedure
Intervention Name(s)
cardio-pulmonary resuscitation
Intervention Description
usual care of cardiac arrest
Primary Outcome Measure Information:
Title
Sequential Organ Failure Assessment score (SOFA)
Time Frame
At 24 hours after hospital admission
Secondary Outcome Measure Information:
Title
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)
Title
Survival
Time Frame
At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)
Title
Good cerebral outcome
Description
Glasgow Coma Scale and Cerebral Performance Categories
Time Frame
At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)
Title
All adverse events
Time Frame
until hospital discharge (an average time frame of 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent ARGAUD, MD, PhD
Organizational Affiliation
Groupement Hospitalier Edouard Herriot,69437 Lyon Cedex 03
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical intensive care unit, Edouard Herriot Hospital
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34116828
Citation
Madelaine T, Cour M, Roy P, Vivien B, Charpentier J, Dumas F, Deye N, Bonnefoy E, Gueugniaud PY, Coste J, Cariou A, Argaud L. Prediction of Brain Death After Out-of-Hospital Cardiac Arrest: Development and Validation of the Brain Death After Cardiac Arrest Score. Chest. 2021 Jul;160(1):139-147. doi: 10.1016/j.chest.2021.01.056. Epub 2021 Jun 8.
Results Reference
derived
PubMed Identifier
27433815
Citation
Argaud L, Cour M, Dubien PY, Giraud F, Jossan C, Riche B, Hernu R, Darmon M, Poncelin Y, Tchenio X, Quenot JP, Freysz M, Kamga C, Beuret P, Usseglio P, Badet M, Anette B, Chaulier K, Alasan E, Sadoune S, Bobbia X, Zeni F, Gueugniaud PY, Robert D, Roy P, Ovize M; CYRUS Study Group. Effect of Cyclosporine in Nonshockable Out-of-Hospital Cardiac Arrest: The CYRUS Randomized Clinical Trial. JAMA Cardiol. 2016 Aug 1;1(5):557-65. doi: 10.1001/jamacardio.2016.1701.
Results Reference
derived

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Cyclosporine A in Cardiac Arrest

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