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

NCT06473207 | Recruiting

• 2 other identifiers: 2023-CHITS-0102023-A02457-38
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

Remote ischemic conditioning; Out-of-hospital cardiac arrest; Neuroprotection; Cardiac arrest

Outcome Measures

Primary Outcomes (1)

• Neurofilament light chain (NFL) blood level evolution between 6 and 72 hours after 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 Outcomes (7)

• Sepsis organ failure assessment score (SOFA)

  72 hours after out-of-hospital cardiac arrest occurrence

• Rate of patients with NFL peak level >500 pg/mL

  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

  72 hours after out-of-hospital cardiac arrest occurrence

• S100B protein (PS100B) blood level evolution between 6 and 72 hours after cardiac arrest occurrence

  72 hours after out-of-hospital cardiac arrest occurrence

• ICU mortality rate from multi-organ failure and from neurological injury

  At intensive care unit (ICU) discharge, up to 28 days

Study Arms (2)

Remote ischemic post-conditioning (RIPOST)

EXPERIMENTAL

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

Sham procedure

SHAM COMPARATOR

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

Interventions

Sham sessions OTHER

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

Also known as: Sham

Sham procedure

Remote ischemic post conditioning sessions OTHER

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

Also known as: RIPOST

Remote ischemic post-conditioning (RIPOST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Patient already included in this study
• Judicial protection measure
• Patient without French social security

Sponsors & Collaborators

• French Society for Intensive Care: collaborator
• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer

Toulon, Var, 83100, France

RECRUITING

Related Publications (5)

• Ho AFW, Chong J, Ong MEH, Hausenloy DJ. Remote Ischemic Conditioning in Emergency Medicine-Clinical Frontiers and Research Opportunities. Shock. 2020 Mar;53(3):269-276. doi: 10.1097/SHK.0000000000001362.

  PMID: 32045394 BACKGROUND

• Kloner RA, Shi J, Dai W, Carreno J, Zhao L. Remote Ischemic Conditioning in Acute Myocardial Infarction and Shock States. J Cardiovasc Pharmacol Ther. 2020 Mar;25(2):103-109. doi: 10.1177/1074248419892603. Epub 2019 Dec 11.

  PMID: 31823646 BACKGROUND

• Albrecht M, Meybohm P, Broch O, Zitta K, Hein M, Grasner JT, Renner J, Bein B, Gruenewald M. Evaluation of remote ischaemic post-conditioning in a pig model of cardiac arrest: A pilot study. Resuscitation. 2015 Aug;93:89-95. doi: 10.1016/j.resuscitation.2015.05.019. Epub 2015 Jun 4.

  PMID: 26051813 BACKGROUND

• England TJ, Hedstrom A, O'Sullivan SE, Woodhouse L, Jackson B, Sprigg N, Bath PM. Remote Ischemic Conditioning After Stroke Trial 2: A Phase IIb Randomized Controlled Trial in Hyperacute Stroke. J Am Heart Assoc. 2019 Dec 3;8(23):e013572. doi: 10.1161/JAHA.119.013572. Epub 2019 Nov 21.

  PMID: 31747864 BACKGROUND

• Moseby-Knappe M, Mattsson N, Nielsen N, Zetterberg H, Blennow K, Dankiewicz J, Dragancea I, Friberg H, Lilja G, Insel PS, Rylander C, Westhall E, Kjaergaard J, Wise MP, Hassager C, Kuiper MA, Stammet P, Wanscher MCJ, Wetterslev J, Erlinge D, Horn J, Pellis T, Cronberg T. Serum Neurofilament Light Chain for Prognosis of Outcome After Cardiac Arrest. JAMA Neurol. 2019 Jan 1;76(1):64-71. doi: 10.1001/jamaneurol.2018.3223.

  PMID: 30383090 BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Chelly Jonathan, MD

  Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer

  STUDY DIRECTOR

Central Study Contacts

Chelly Jonathan, MD

CONTACT

0494145124; Jonathan.chelly@ch-toulon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 25, 2024
• Study Start: January 11, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)