Clinical trial NCT06306625: REmote COnditioning in Out-of-Hospital Cardiac Arrest
Official title: REmote Ischemic COnditioning in Out-of-Hospital Cardiac Arrest: The RECO-OHCA Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: Out-of-hospital cardiac arrest
remote conditioning
ischemic conditioning
ischemia-reperfusion
intensive care unit
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: All cause of death
timeFrame: 72 hours after hospital admission
measure: Multiple organ failure
timeFrame: 72 hours after hospital admission
measure: Severe neurological failure
timeFrame: 72 hours after hospital admission
Secondary outcomes:
measure: Sepsis-related Organ Failure Assessment (SOFA) score
timeFrame: 24 hours after hospital admission
measure: Sepsis-related Organ Failure Assessment (SOFA) score
timeFrame: 48 hours after hospital admission
measure: Sepsis-related Organ Failure Assessment (SOFA) score
timeFrame: 72 hours after hospital admission
measure: Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score
timeFrame: 24 hours after hospital admission
measure: Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score
timeFrame: 48 hours after hospital admission
measure: Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score
timeFrame: 72 hours after hospital admission
measure: Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction
timeFrame: 24 hours after hospital admission
measure: Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction
timeFrame: 48 hours after hospital admission
measure: Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction
timeFrame: 72 hours after hospital admission
measure: Mean Sepsis-related Organ Failure Assessment (SOFA) score
timeFrame: From hospital admission to 72 hours (or from hospital admission to death if it occurs before 72 hours)
measure: Mean Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score
timeFrame: From hospital admission to 72 hours (or from hospital admission to death if it occurs before 72 hours)
measure: Variations of the Sepsis-related Organ Failure Assessment (SOFA) score (delta-SOFA)
timeFrame: Between hospital admission to 24 hours, admission to 48 hours and admission to 72 hours
measure: Variations of the Sepsis-related Organ Failure Assessment (SOFA) score (delta-SOFA) after exclusion of the neurological sub-score
timeFrame: Between hospital admission to 24 hours, admission to 48 hours and admission to 72 hours
measure: Serum level of neuron-specific enolase (NSE)
timeFrame: Between 48 and 72 hours after hospital admission
measure: Cerebral Performance Categories (CPC) scale
timeFrame: Day 90
measure: All-cause mortality
timeFrame: From date of randomization until day 90 after hospital admission
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied, CHU de Clermont Ferrand
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin, Clermont-Ferrand
city: Dijon
country: France
facility: Hôpital F Mitterrand, CHU de Dijon
city: La Tronche
country: France
facility: Hôpital Albert Michallon, CHU de Grenoble
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Hôpital Saint-Joseph Saint-Luc
city: Marseille
country: France
facility: Hôpital de la Timone, CHU de Marseille
city: Montpellier
country: France
facility: Hôpital lapeyronie, CHU de Montpellier
city: Nîmes
country: France
facility: Hôpital Universitaire Carémeau
city: Paris
country: France
facility: Hôpital Lariboisière, APHP, Réanimation Médicale et Toxicologique
city: Pierre-Bénite
country: France
facility: Hôpital Lyon-Sud
city: Saint-Priest-en-Jarez
country: France
facility: Hôpital Nord, CHU de St Etienne
city: Villefranche-sur-Saône
country: France
facility: Hôpital Nord-Ouest
Study officials:
References: