Cyclosporine A in Cardiac Arrest

Phase 3

Completed

• Conditions: Non Shockable Out of Hospital Cardiac Arrest
• Interventions: Drug: Cyclosporine A; Procedure: cardio-pulmonary resuscitation

• Registration Number: NCT01595958
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 796

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclosporine A	Cyclosporine A	Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
Cyclosporine A	cardio-pulmonary resuscitation	Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
Control	cardio-pulmonary resuscitation	usual care of cardiac arrest

Primary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment score (SOFA)	At 24 hours after hospital admission

Secondary Outcome Measures

Name	Time	Method
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)
Survival	At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)
Good cerebral outcome	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
All adverse events	until hospital discharge (an average time frame of 7 days)

Trial Locations

Locations (1)

Medical intensive care unit, Edouard Herriot Hospital; 🇫🇷 Lyon, France