NCT06473207 Neuroprotective Effect of Remote Ischemic Post-conditioning in Out-of-hospital Cardiac Arrest
| NCT ID | NCT06473207 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer |
| Condition | Out-Of-Hospital Cardiac Arrest |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-01-11 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-01-11 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Chelly Jonathan, MD
STUDY DIRECTOR
Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer
Frequently Asked Questions
Who can join the NCT06473207 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Out-Of-Hospital Cardiac Arrest. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06473207 currently recruiting?
Yes, NCT06473207 is actively recruiting participants. Contact the research team at Jonathan.chelly@ch-toulon.fr for enrollment information.
Where is the NCT06473207 trial being conducted?
This trial is being conducted at Toulon, France.
Who is sponsoring the NCT06473207 clinical trial?
NCT06473207 is sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. The principal investigator is Chelly Jonathan, MD at Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer. The trial plans to enroll 48 participants.