RecruitingNot ApplicableNCT06306625

REmote COnditioning in Out-of-Hospital Cardiac Arrest

REmote Ischemic COnditioning in Out-of-Hospital Cardiac Arrest: The RECO-OHCA Study


Sponsor

Hospices Civils de Lyon

Enrollment

220 participants

Start Date

Jun 21, 2024

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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

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Interventions

DEVICERemote 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.

DEVICENo remote ischemic conditioning

A brachial cuff is positioned around the arm of the patient and no inflation or deflation is performed.


Locations(14)

Hôpital Louis Pradel

Bron, France

Hôpital Gabriel Montpied, CHU de Clermont Ferrand

Clermont-Ferrand, France

Centre Jean Perrin, Clermont-Ferrand

Clermont-Ferrand, France

Hôpital F Mitterrand, CHU de Dijon

Dijon, France

Hôpital Albert Michallon, CHU de Grenoble

La Tronche, France

Hôpital Edouard Herriot

Lyon, France

Hôpital Saint-Joseph Saint-Luc

Lyon, France

Hôpital de la Timone, CHU de Marseille

Marseille, France

Hôpital lapeyronie, CHU de Montpellier

Montpellier, France

Hôpital Universitaire Carémeau

Nîmes, France

Hôpital Lariboisière, APHP, Réanimation Médicale et Toxicologique

Paris, France

Hôpital Lyon-Sud

Pierre-Bénite, France

Hôpital Nord, CHU de St Etienne

Saint-Priest-en-Jarez, France

Hôpital Nord-Ouest

Villefranche-sur-Saône, France

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NCT06306625