Using remote ischemic conditioning to protect the brain after cardiac arrest

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

This study is testing if a new treatment called remote ischemic conditioning can help protect the brains of people who have had a cardiac arrest.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (other)
• Locations: 1 site (Toulon, Var)
• Trial ID: NCT06473207 on ClinicalTrials.gov

What this trial studies

This trial investigates the neuroprotective effects of remote ischemic post-conditioning (RIPOST) in patients who have experienced an out-of-hospital cardiac arrest. Participants will be randomly assigned to either an experimental group receiving standard care plus RIPOST sessions or a control group receiving standard care plus sham sessions. The RIPOST sessions involve cycles of limb ischemia and reperfusion aimed at reducing brain injury caused by ischemia-reperfusion syndrome. The study will last for 27 months, with patient participation lasting 3 months.

Who should consider this trial

Good fit: Ideal candidates are adults who have experienced an out-of-hospital cardiac arrest with stable return of spontaneous circulation and require invasive mechanical ventilation.

Not a fit: Patients under 18 years old, pregnant women, or those with severe disabilities requiring constant care may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve neurological outcomes for patients recovering from out-of-hospital cardiac arrest.

How similar studies have performed: Pre-clinical studies have shown promising results for similar approaches, indicating potential for success in this trial.

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
* Judicial protection measure
* Patient without French social security

Where this trial is running

Toulon, Var

• Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer — Toulon, Var, France (RECRUITING)

Study contacts

• Study coordinator: Chelly Jonathan, MD

Conditions: Out-Of-Hospital Cardiac Arrest, Remote ischemic conditioning, Out-of-hospital cardiac arrest, Neuroprotection, Cardiac arrest