Neuroprotective Effect of Remote Ischemic Post-conditioning in Out-of-hospital Cardiac Arrest (RIPOST-CA)

April 10, 2026 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The RIPOST trial is a prospective, single-center, randomized, open-label, parallel group trial.

Patients with inclusion criteria will be randomized in two parallel groups:

  • Experimental group: standard of care associated to 3 RIPOST sessions : one within the 4 hours following cardiac arrest, one 12 hours after cardiac arrest and one 24 hours after cardiac arrest. A RIPOST session = four cycles of cuff inflation to 200 mmHg for five minutes and then deflation to 0 mmHg for another five minutes, using an inflatable thigh tourniquet (total duration of the session = 40 minutes).
  • Control group: standard of care associated to 3 sham sessions at inclusion, 24, and 48 hours after inclusion. A sham session = application of the thigh tourniquet during 40 minutes without any inflation.

Inclusion duration: 24 months

Patient participation duration: 3 months

Study duration: 27 months

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Var
      • Toulon, Var, France, 83100
        • Recruiting
        • Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Other: 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
Other Names:
  • RIPOST
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)
Other: 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
Other Names:
  • Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurofilament light chain (NFL) blood level evolution between 6 and 72 hours after cardiac arrest occurrence
Time Frame: 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)
72 hours after out-of-hospital cardiac arrest occurrence

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sepsis organ failure assessment score (SOFA)
Time Frame: 72 hours after out-of-hospital cardiac arrest occurrence
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
Time Frame: 72 hours after out-of-hospital cardiac arrest occurrence
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
Time Frame: 72 hours after out-of-hospital 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
Time Frame: 72 hours after out-of-hospital 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
Time Frame: At intensive care unit (ICU) discharge, up to 28 days
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)
Time Frame: 90 days after out-of-hospital cardiac arrest occurrence
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
Time Frame: 24 hours after out-of-hospital cardiac arrest 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Collaborators

French Society for Intensive Care

Investigators

  • Study Director: Chelly Jonathan, MD, Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-CHITS-010
  • 2023-A02457-38 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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