Cyclosporine A in Cardiac Arrest
Phase 3
Completed
- Conditions
- Non Shockable Out of Hospital Cardiac Arrest
- Interventions
- 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
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)
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does Cyclosporine A target to inhibit mitochondrial permeability transition pores in post-cardiac arrest syndrome?
How does Cyclosporine A administration during CPR compare to standard-of-care treatments in non-shockable out-of-hospital cardiac arrest outcomes?
Which biomarkers are associated with improved survival following Cyclosporine A administration in post-cardiac arrest patients?
What are the potential adverse events of Cyclosporine A in cardiac arrest patients and how can they be managed?
Are there alternative drugs or combination therapies targeting mitochondrial permeability transition pores for post-cardiac arrest syndrome?
Trial Locations
- Locations (1)
Medical intensive care unit, Edouard Herriot Hospital
🇫🇷Lyon, France
Medical intensive care unit, Edouard Herriot Hospital🇫🇷Lyon, France