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Recruiting Not applicable

REmote COnditioning in Out-of-Hospital Cardiac Arrest

NCT06306625 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-06-21
Last updated
2025-02-12

Condition(s) studied

Out-Of-Hospital Cardiac Arrest

Investigational drug(s) / intervention(s)

Remote ischemic conditioningNo remote ischemic conditioning

Remote ischemic conditioning: A brachial cuff is positioned around one arm of the patient. Remote ischemic conditioning consists of four cycles of a 5-min brachial cuff inflation at 200 mmHg followed by a 5-min of cuff deflation, and is started as soon as possible after randomization. The intervention is repeated 12 and 24 hours after inclusion.

No remote ischemic conditioning: A brachial cuff is positioned around the arm of the patient and no inflation or deflation is performed.

Study summary

Out-of-Hospital Cardiac Arrest remains a major public health problem, resulting in high mortality largely related to multiple organ failure and poor neurological outcomes due to brain anoxia. The pathophysiology of organ dysfunction after resuscitated out-of-hospital cardiac arrest involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy used to protect organs against the detrimental effects of ischemia-reperfusion injury.

The objective of the present trial is to determine whether remote ischemic conditioning performed early after out-of-hospital cardiac arrest can decrease mortality, or multiple organ failure and/or severe neurological failure.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 18 and 80 years old * Out-of-hospital cardiac arrest, whatever the initial cardiac rhythm (shockable or non-shockable) or the duration of no-flow and low-flow, * Presence of a witness who may or may not have started cardiopulmonary resuscitation, or patient seen alive in the 30 minutes prior to the cardiac arrest, * Hospitalisation in critical care (intensive care unit or cardiac intensive care unit) for less than 3 hours, * Informed consent obtained from a close relative (exceptionally from the patient himself if his condition permits) or, failing this, use of the emergency procedure by the investigator. Exclusion Criteria: * Traumatic cardiac arrest * Patient on extracorporeal circulatory assistance * Cardiac arrest for which continuation of resuscitation does not appear justified (unavoidable death, terminal stage of an irreversible disease, etc.) * Contraindication of the use of brachial cuff on both arms (arteriovenous fistula, lymphoedema or severe peripheral vascular pathology, unstable humeral fracture, continuous infusion into an upper limb vein of an essential drug such as a catecholamine, radial arterial catheter for continuous invasive measurement of blood pressure) * Pregnant, parturient, or breast-feeding women * Patients deprived of their liberty by a judicial or administrative decision, * Patients under legal protection (guardianship, curatorship), * Patient not affiliated to a social security scheme or beneficiary of a similar scheme, * Previous inclusion in the study, * Subject participating in other interventional research that may interfere with the present study according to the investigator's judgement or that includes an exclusion period still in progress at inclusion

Primary outcome measure(s)

  • All cause of death — 72 hours after hospital admission
    All-cause death will be assessed 72 hours after hospital admission.
  • Multiple organ failure — 72 hours after hospital admission
    Multiple organ failure is defined by a SOFA (Sepsis-related Organ Failure Assessment) score, censored for the neurological component, greater than or equal to 5.
  • Severe neurological failure — 72 hours after hospital admission
    Severe neurological failure is defined by a motor component of the Glasgow Coma Score less than or equal to 3, without confounding factors (hypothermia less than or equal to 35.0°C, and/or sedation/analgesia/curarization). The glasgow coma score ranges from 3 to 15 and is broken down into its three parameters: eye opening, verbal response and motor response. The higher the score, the better the patient's recovery.

Trial sites (14)

FacilityCityRegionStatus
Hôpital Louis Pradel Bron France Not Yet Recruiting
Hôpital Gabriel Montpied, CHU de Clermont Ferrand Clermont-Ferrand France Not Yet Recruiting
Centre Jean Perrin, Clermont-Ferrand Clermont-Ferrand France Not Yet Recruiting
Hôpital F Mitterrand, CHU de Dijon Dijon France Not Yet Recruiting
Hôpital Albert Michallon, CHU de Grenoble La Tronche France Not Yet Recruiting
Hôpital Edouard Herriot Lyon France Recruiting
Hôpital Saint-Joseph Saint-Luc Lyon France Recruiting
Hôpital de la Timone, CHU de Marseille Marseille France Recruiting
Hôpital lapeyronie, CHU de Montpellier Montpellier France Recruiting
Hôpital Universitaire Carémeau Nîmes France Not Yet Recruiting
Hôpital Lariboisière, APHP, Réanimation Médicale et Toxicologique Paris France Not Yet Recruiting
Hôpital Lyon-Sud Pierre-Bénite France Recruiting
Hôpital Nord, CHU de St Etienne Saint-Priest-en-Jarez France Recruiting
Hôpital Nord-Ouest Villefranche-sur-Saône France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06306625 on ClinicalTrials.gov ↗ ← All trials in France