REmote COnditioning in Out-of-Hospital Cardiac Arrest (RECO-OHCA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Device: Remote ischemic conditioning; Device: No remote ischemic conditioning

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Line HARLAY; Phone Number: +33 04 72 11 28 62; Email: marie-line.harlay@chu-lyon.fr
• Study Contact Backup: Name: Naoual EL JONHY; Phone Number: +33 0472356912; Email: naoual.el-jonhy@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Not yet recruiting
    • Hôpital Louis Pradel
    • Contact: Thomas BOCHATON; Phone Number: +33 04 72 35 75 41; Email: thomas.bochaton@chu-lyon.fr
    • Principal Investigator: Thomas BOCHATON
  • Clermont-Ferrand, France, 63000
    • Not yet recruiting
    • Hôpital Gabriel Montpied, CHU de Clermont Ferrand
    • Contact: Maxime DUMESNIL; Phone Number: +33 04 73 75 07 50; Email: mdumesnil@chu-clermontferrand.fr
    • Principal Investigator: Maxime DUMESNIL
  • Clermont-Ferrand, France, 69300
    • Not yet recruiting
    • Centre Jean Perrin, Clermont-Ferrand
    • Principal Investigator: Alexandre LAUTRETTE
    • Contact: Alexandre LAUTRETTE; Phone Number: +33 04 73 27 80 80; Email: alautrette@chu-clermontferrand.fr
  • Dijon, France, 21079
    • Not yet recruiting
    • Hôpital F Mitterrand, CHU de Dijon
    • Contact: Jean-Pierre QUENOT; Phone Number: +33 03 80 29 37 51; Email: jean-pierre.quenot@chu-dijon.fr
    • Principal Investigator: Jean-Pierre QUENOT
  • La Tronche, France, 38700
    • Not yet recruiting
    • Hôpital Albert Michallon, CHU de Grenoble
    • Principal Investigator: Carole SCHWEBEL
    • Contact: Carole SCHWEBEL; Phone Number: +33 04 76 76 87 79; Email: cschwebel@chu-grenoble.fr
  • Lyon, France, 69003
    • Recruiting
    • Hopital Edouard Herriot
    • Sub-Investigator: Laurent ARGAUD
    • Contact: Marie-Line HARLAY; Phone Number: +33 04 72 11 28 62; Email: marie-line.harlay@chu-lyon.fr
    • Contact: Laurent ARGAUD; Phone Number: +33 04 72 11 28 62; Email: laurent.argaud@chu-lyon.fr
    • Principal Investigator: Marie-Line HARLAY
    • Sub-Investigator: Martin COUR
  • Lyon, France, 69007
    • Recruiting
    • Hôpital Saint-Joseph Saint-Luc
    • Principal Investigator: Emmanuel Vivier
    • Contact: Emmanuel VIVIER; Phone Number: +33 04 78 61 82 09; Email: evivier@ch-stjosephstluc-lyon.fr
  • Marseille, France, 13385
    • Recruiting
    • Hôpital de la Timone, CHU de Marseille
    • Contact: Marc GAINNIER; Phone Number: +33 04 91 38 85 50; Email: marc.gainnier@ap-hm.fr
    • Principal Investigator: Marc GAINNIER
  • Montpellier, France, 34295
    • Recruiting
    • Hôpital lapeyronie, CHU de Montpellier
    • Contact: Kada KLOUCHE; Phone Number: +33 04 67 33 77 36; Email: k-klouche@chu-montpellier.fr
    • Principal Investigator: Kada KLOUCHE
  • Nîmes, France, 30029
    • Not yet recruiting
    • Hopital Universitaire Caremeau
    • Principal Investigator: Claire Roger
    • Contact: Claire ROGER; Phone Number: +33 04 66 68 33 31; Email: claire.roger@chu-nimes.fr
  • Paris, France, 75010
    • Not yet recruiting
    • Hôpital Lariboisière, APHP, Réanimation Médicale et Toxicologique
    • Contact: Sebastian VOICU; Phone Number: +33 01 49 95 84 42; Email: sebastian.voicu@aphp.fr
    • Principal Investigator: Sebastian VOICU
  • Pierre-Bénite, France, 69310
    • Recruiting
    • Hôpital Lyon-Sud
    • Contact: Auguste DARGENT; Phone Number: +33 04 78 86 21 18; Email: auguste.dargent@chu-lyon.fr
    • Principal Investigator: Auguste DARGENT
  • Saint-Priest-en-Jarez, France, 42270
    • Recruiting
    • Hôpital Nord, CHU de St Etienne
    • Principal Investigator: Guillaume THIERY
    • Contact: Guillaume THIERY; Phone Number: +33 04 77 12 78 62; Email: guillaume.thiery@chu-st-etienne.fr
  • Villefranche-sur-Saône, France, 69655
    • Recruiting
    • Hôpital Nord-Ouest
    • Contact: Julien ILLINGER; Phone Number: +33 04 74 09 29 31; Email: jillinger@hno.fr
    • Principal Investigator: Julien ILLINGER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote ischemic conditioning; A brachial cuff is positioned around one arm of the patient. Remote ischemic conditioning consists of alternating inflations and deflations of the brachial cuff. Four cycles of ischemic conditioning (5-min brachial cuff inflation at 200 millimetres of mercury (mmHg) followed by 5-min cuff deflation) are started as soon as possible after inclusion. The intervention is repeated 12 and 24 hours after inclusion.	Device: 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.
Other: Control group; A brachial cuff is positioned around one arm of the patient. Neither inflation nor deflation is performed.	Device: No remote ischemic conditioning; A brachial cuff is positioned around the arm of the patient and no inflation or deflation is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause of death	All-cause death will be assessed 72 hours after hospital admission.	72 hours after hospital admission
Multiple organ failure	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.	72 hours after hospital admission
Severe neurological failure	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.	72 hours after hospital admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sepsis-related Organ Failure Assessment (SOFA) score	The SOFA score ranges from 0 to 24 (higher scores indicate more severe organ failure), with 0 to 4 points assigned for each of 6 organ dysfunctions (ie, central nervous system, cardiovascular, respiratory, renal, coagulation, and liver).	24 hours after hospital admission
Sepsis-related Organ Failure Assessment (SOFA) score	The SOFA score ranges from 0 to 24 (higher scores indicate more severe organ failure), with 0 to 4 points assigned for each of 6 organ dysfunctions (ie, central nervous system, cardiovascular, respiratory, renal, coagulation, and liver).	48 hours after hospital admission
Sepsis-related Organ Failure Assessment (SOFA) score	The SOFA score ranges from 0 to 24 (higher scores indicate more severe organ failure), with 0 to 4 points assigned for each of 6 organ dysfunctions (ie, central nervous system, cardiovascular, respiratory, renal, coagulation, and liver).	72 hours after hospital admission
Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score		24 hours after hospital admission
Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score		48 hours after hospital admission
Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score		72 hours after hospital admission
Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction	Average SOFA sub-scores for each organ failure scored from 0 to 4 points	24 hours after hospital admission
Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction	Average SOFA sub-scores for each organ failure scored from 0 to 4 points	48 hours after hospital admission
Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction	Average SOFA sub-scores for each organ failure scored from 0 to 4 points	72 hours after hospital admission
Mean Sepsis-related Organ Failure Assessment (SOFA) score		From hospital admission to 72 hours (or from hospital admission to death if it occurs before 72 hours)
Mean Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score		From hospital admission to 72 hours (or from hospital admission to death if it occurs before 72 hours)
Variations of the Sepsis-related Organ Failure Assessment (SOFA) score (delta-SOFA)		Between hospital admission to 24 hours, admission to 48 hours and admission to 72 hours
Variations of the Sepsis-related Organ Failure Assessment (SOFA) score (delta-SOFA) after exclusion of the neurological sub-score		Between hospital admission to 24 hours, admission to 48 hours and admission to 72 hours
Serum level of neuron-specific enolase (NSE)		Between 48 and 72 hours after hospital admission
Cerebral Performance Categories (CPC) scale	The neurological performance is assessed using the cerebral performance categories (CPC) scale, which ranges from 1 to 5 (with 1 representing good cerebral performance or minor disability, 2 moderate disability, 3 severe disability, 4 coma or vegetative state, and 5 brain death or dead).	Day 90
All-cause mortality		From date of randomization until day 90 after hospital admission

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2024
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): October 5, 2026

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: intensive care unit; ischemia-reperfusion; Out-of-hospital cardiac arrest; ischemic conditioning; remote conditioning
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 69HCL21_0001; 2023-A01315-40 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No