Cyclosporine A in Cardiac Arrest (CYRUS)

April 30, 2014 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

796

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Medical intensive care unit, Edouard Herriot Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sequential Organ Failure Assessment score (SOFA)
Time Frame: At 24 hours after hospital admission
At 24 hours after hospital admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At 24 hours following admission, at day 28, at hospital discharge (an average time frame of 7 days)
Survival
Time Frame: At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)
At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)
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
At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)
All adverse events
Time Frame: until hospital discharge (an average time frame of 7 days)
until hospital discharge (an average time frame of 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Laurent ARGAUD, MD, PhD, Groupement Hospitalier Edouard Herriot,69437 Lyon Cedex 03

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 10, 2012

Study Record Updates

Last Update Posted (Estimate)

May 1, 2014

Last Update Submitted That Met QC Criteria

April 30, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009.571
  • 2009-015725-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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