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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer
RECRUITING
Toulon
Contact Information
Primary
Chelly Jonathan, MD
Jonathan.chelly@ch-toulon.fr
0494145124
Time Frame
Start Date: 2025-01-11
Estimated Completion Date: 2027-04
Participants
Target number of participants: 48
Treatments
Experimental: Remote ischemic post-conditioning (RIPOST)
Patients subjected to three sessions of RIPOST (within the 4 hours following cardiac arrest and then 12 and 24 hours after cardiac arrest)
Sham_comparator: Sham procedure
Patients subjected to three sessions of a sham procedure (within the 4 hours following cardiac arrest and then 12 and 24 hours after cardiac arrest)
Related Therapeutic Areas
Sponsors
Collaborators: French Society for Intensive Care
Leads: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

This content was sourced from clinicaltrials.gov