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

NCT06473207 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Phase

Not applicable

Started

2025-01-11

Last updated

2026-07-07

Condition(s) studied

Out-Of-Hospital Cardiac Arrest

Investigational drug(s) / intervention(s)

Remote ischemic post conditioning sessionsSham sessions

Remote 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

Sham 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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 criteria : * 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 which purpose is to improve prognosis after a cardiac arrest * Judicial protection measure * Patient without French social security

Primary outcome measure(s)

Neurofilament light chain (NFL) blood level evolution between 6 and 72 hours after cardiac arrest occurrence — 72 hours after out-of-hospital 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)

Trial sites (1)

Facility	City	Region	Status
Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer	Toulon	Var	Recruiting

More Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer trials in France

Eccentric or Concentric Contralateral Training in Rehabilitation After Shoulder Surgery With Elbow Immobilization Recruiting

Evaluation of the Care Pathway Offered by the "Chronic Disease Unit" to Obese Patients Recruiting

3D Printers for Autonomy in the Care of Inpatients in Continuing and Rehabilitation Care Recruiting

Monitoring of Patient Physiological Parameters in Real Life Using OXYFLEX® Biosensors Versus Standard Monitoring Starting soon

Efficacy of Therapy With PRP Injections Versus HA in Patients With Advanced Grade of GONArthrosis Recruiting

Other trials for the same condition

REmote COnditioning in Out-of-Hospital Cardiac Arrest Recruiting

Refractory Cardiac Arrest Treated On Field By ECMO Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06473207 on ClinicalTrials.gov ↗ ← All trials in France