RecruitingNot ApplicableNCT06473207

Neuroprotective Effect of Remote Ischemic Post-conditioning in Out-of-hospital Cardiac Arrest

Neuroprotective Effect of Remote Ischemic Post-conditioning in Out-of-hospital Cardiac Arrest : a Randomized Open Label Controlled Trial

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Enrollment

48 participants

Start Date

Jan 11, 2025

Study Type

INTERVENTIONAL

Conditions

Out-of-hospital cardiac arrest

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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
Consent of a next-of-kin or inclusion in emergency procedure

Exclusion Criteria15

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
In-hospital cardiac arrest
Refractory cardiac arrest (no ROSC considered as stable)
Cardiac arrest from traumatic, hemorrhage, stroke or hanging supposed origin
Mean arterial pressure < 65mmHg persisting despite appropriate vascular filling and vasopressor and/or inotropic support
Active uncontrolled bleeding
Contraindication or not possible to use a pneumatic tourniquet on none of the two lower limbs (amputations, intravenous infusion positioned on both lower limbs, tourniquet size incompatible with patient morphology)
Implementation of extracorporeal arteriovenous circulation for refractory cardiac arrest or refractory cardiogenic shock before inclusion
Patient already included in this study
Inclusion in another interventional study
Judicial protection measure
Patient without French social security

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Interventions

OTHERRemote ischemic post conditioning sessions

Three 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

OTHERSham sessions

Three 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