REmote COnditioning in Out-of-Hospital Cardiac Arrest

NCT06306625 | Recruiting

• 2 other identifiers: 69HCL21_00012023-A01315-40
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 14

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.

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

Out-of-hospital cardiac arrest; remote conditioning; ischemic conditioning; ischemia-reperfusion; intensive care unit

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Sepsis-related Organ Failure Assessment (SOFA) score

  24 hours after hospital admission

• Sepsis-related Organ Failure Assessment (SOFA) score

  48 hours after hospital admission

• Sepsis-related Organ Failure Assessment (SOFA) score

  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

Study Arms (2)

Remote ischemic conditioning

EXPERIMENTAL

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

Control group

OTHER

A brachial cuff is positioned around one arm of the patient. Neither inflation nor deflation is performed.

Device: No remote ischemic conditioning

Interventions

Remote ischemic conditioning DEVICE

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.

Remote ischemic conditioning

No remote ischemic conditioning DEVICE

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (14)

Hôpital Louis Pradel

Bron, 69500, France

NOT YET RECRUITING

Hôpital Gabriel Montpied, CHU de Clermont Ferrand

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Centre Jean Perrin, Clermont-Ferrand

Clermont-Ferrand, 69300, France

NOT YET RECRUITING

Hôpital F Mitterrand, CHU de Dijon

Dijon, 21079, France

NOT YET RECRUITING

Hôpital Albert Michallon, CHU de Grenoble

La Tronche, 38700, France

NOT YET RECRUITING

Hôpital Edouard Herriot

Lyon, 69003, France

RECRUITING

Hôpital Saint-Joseph Saint-Luc

Lyon, 69007, France

RECRUITING

Hôpital de la Timone, CHU de Marseille

Marseille, 13385, France

RECRUITING

Hôpital lapeyronie, CHU de Montpellier

Montpellier, 34295, France

RECRUITING

Hôpital Universitaire Carémeau

Nîmes, 30029, France

NOT YET RECRUITING

Hôpital Lariboisière, APHP, Réanimation Médicale et Toxicologique

Paris, 75010, France

NOT YET RECRUITING

Hôpital Lyon-Sud

Pierre-Bénite, 69310, France

RECRUITING

Hôpital Nord, CHU de St Etienne

Saint-Priest-en-Jarez, 42270, France

RECRUITING

Hôpital Nord-Ouest

Villefranche-sur-Saône, 69655, France

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Marie-Line Harlay

CONTACT

04 72 11 28 62; marie-line.harlay@chu-lyon.fr

Naoual EL JONHY

CONTACT

0472356912; naoual.el-jonhy@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: March 12, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): October 5, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

FR (14)