Patients admitted to intensive care unit (ICU) following an out-of-hospital cardiac arrest (OHCA) have a high morbidity and mortality rate, primarily due to ischemia-reperfusion (I/R) syndrome leading to anoxic-ischemic brain injury. Despite current recommended advanced life support therapies, no specific treatment or procedure has yet been shown to improve the neurological outcome of such patients.
Remote ischemic post-conditioning (RIPOST) which usually consists of applying brief and repeated cycles of ischemia alternating with reperfusion by inflating and deflating a blood pressure cuff or a pneumatic tourniquet placed around a limb, is a promising strategy to protect organs against I/R injury, including brain. Regarding cardiac arrest, pre-clinical studies have demonstrated an improvement in neurological outcome in animal subjects treated with RIPOST after cardiopulmonary resuscitation.
The aim of our study is to demonstrate the benefit of early RIPOST in OHCA patients in reducing neurological injury and organ failure related to I/R syndrome.
Out-of-hospital cardiac arrest with stable return of spontaneous circulation (ROSC > 20 minutes)
Patient receiving invasive mechanical ventilation for coma (Glasgow score < 8)
Availability of a lower limb without intravenous infusion or tension cuff positioned on it
Randomization and application of the first session of the tested procedure within 4 hours after ROSC
Age < 18 y.o or pregnancy
Patient unable to walk without assistance, unable to support himself properly without assistance, bedridden, incontinent and requiring nursing constant attention and care (corresponding to a mRS equal to 4 or 5)
Interval between cardiac arrest and ROSC (no flow + low flow) estimated > 60 minutes
Unwitnessed cardiac arrest with asystole as first rhythm
Parallel
Remote ischemic post conditioning sessions
Other interventionThree sessions of RIPOST (within the 4 hours following cardiac arrest and then 12 and 24 hours after cardiac arrest), as follows: four cycles of cuff inflation to 200 mmHg for 5 min and then deflation to 0 mmHg for another 5 min (40 min total duration of the intervention), using an inflatable thigh tourniquet
Sham sessions
Other interventionThree sessions of a sham procedure (within the 4 hours following cardiac arrest and then 12 and 24 hours after cardiac arrest), as follows : application of a thigh tourniquet during 40 min without any inflation
Neurofilament light chain (NFL) blood level evolution between 6 and 72 hours after cardiac arrest occurrence
Blood samples will be performed at 6 and 72 hours after cardiac arrest to monitor NFL level evolution and this evolution will be compared between both arms (RIPOST and sham groups)
Sepsis organ failure assessment score (SOFA)
SOFA will be assessed at 24, 48 and 72 hours after cardiac arrest, and compared between both arms
Rate of patients with NFL peak level >500 pg/mL
Blood samples will be performed at 6, 24, 48 and 72 hours after cardiac arrest to monitor NFL peak level and the rate of patients who will present a NFL peak level \> 500 pg/mL will be compared between both arms.
Neuron-specific enolase (NSE) blood level evolution between 6 and 72 hours after cardiac arrest occurrence
Blood samples will be performed at 6, 24, 48 and 72 hours after cardiac arrest to monitor NSE levels and their evolution will be compared between both arms (RIPOST and sham groups)
S100B protein (PS100B) blood level evolution between 6 and 72 hours after cardiac arrest occurrence
Blood samples will be performed at 6, 24, 48 and 72 hours after cardiac arrest to monitor PS100B levels and their evolution will be compared between both arms (RIPOST and sham groups)
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead sponsor
French Society for Intensive Care
Collaborator
