Neuroprotective Effect of Remote Ischemic Post-conditioning in Out-of-hospital Cardiac Arrest
NCT Number: NCT06473207
Acronym: RIPOST-CA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Interventions: OTHER: Remote ischemic post conditioning sessions|OTHER: Sham sessions
Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators: French Society for Intensive Care
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-01
Locations: Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer, Toulon, Var, 83100, France

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.

Primary Outcome Measures: 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), 72 hours after out-of-hospital cardiac arrest occurrence
Secondary Outcome Measures: Sepsis organ failure assessment score (SOFA), SOFA will be assessed at 24, 48 and 72 hours after cardiac arrest, and compared between both arms, 72 hours after out-of-hospital cardiac arrest occurrence|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., 72 hours after out-of-hospital cardiac arrest occurrence|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), 72 hours after out-of-hospital cardiac arrest occurrence|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), 72 hours after out-of-hospital cardiac arrest occurrence|ICU mortality rate from multi-organ failure and from neurological injury, Death mode at ICU discharge will be collected in both arms, At intensive care unit (ICU) discharge, up to 28 days|Modified Rankin Scale (mRS), Modified Rankin Scale (mRS) will be assessed for both arms, at patient's ICU discharge and at day 90 after inclusion. This scales goes from 0 to 6, 0 corresponding to the absence of cognitive deficits and 6 to death., 90 days after out-of-hospital cardiac arrest occurrence|Post out-of-hospital cardiac arrest event occurrence, Post out-of-hospital cardiac arrest event occurrence will be compared between both arms within the 24 hours following cardiac arrest. Events that will be considered are : unexpected cardiac arrest in ICU, iatrogenic events, limb ischemia, occlusive syndrome, digestive ischemia and thromboembolic complications., 24 hours after out-of-hospital cardiac arrest occurrence