Clinical trial NCT01595958: Cyclosporine A in Cardiac Arrest
Official title: CYclosporine A in Non-shockable Out-of-hospital Cardiac Arrest ResUScitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 796
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Sequential Organ Failure Assessment score (SOFA)
timeFrame: At 24 hours after hospital admission
Secondary outcomes:
measure: Hospital admission with return of spontaneous circulation
timeFrame: At 24 hours following admission, at day 28, at hospital discharge (an average time frame of 7 days)
measure: Survival
timeFrame: At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)
measure: Good cerebral outcome
timeFrame: At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)
measure: All adverse events
timeFrame: until hospital discharge (an average time frame of 7 days)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Medical intensive care unit, Edouard Herriot Hospital
Study officials:
affiliation: Groupement Hospitalier Edouard Herriot,69437 Lyon Cedex 03
name: Laurent ARGAUD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.