REmote COnditioning in Out-of-Hospital Cardiac Arrest

NCT ID: NCT06306625

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-21

Study Completion Date

2026-10-05

Brief Summary

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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.

Detailed Description

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Conditions

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Out-Of-Hospital Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Remote ischemic conditioning

Intervention Type 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.

Control group

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

Group Type OTHER

No remote ischemic conditioning

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

No remote ischemic conditioning

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Louis Pradel

Bron, , France

Site Status NOT_YET_RECRUITING

Hôpital Gabriel Montpied, CHU de Clermont Ferrand

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

Centre Jean Perrin, Clermont-Ferrand

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

Hôpital F Mitterrand, CHU de Dijon

Dijon, , France

Site Status NOT_YET_RECRUITING

Hôpital Albert Michallon, CHU de Grenoble

La Tronche, , France

Site Status NOT_YET_RECRUITING

Hôpital Edouard Herriot

Lyon, , France

Site Status RECRUITING

Hôpital Saint-Joseph Saint-Luc

Lyon, , France

Site Status RECRUITING

Hôpital de la Timone, CHU de Marseille

Marseille, , France

Site Status RECRUITING

Hôpital lapeyronie, CHU de Montpellier

Montpellier, , France

Site Status RECRUITING

Hôpital Universitaire Carémeau

Nîmes, , France

Site Status NOT_YET_RECRUITING

Hôpital Lariboisière, APHP, Réanimation Médicale et Toxicologique

Paris, , France

Site Status NOT_YET_RECRUITING

Hôpital Lyon-Sud

Pierre-Bénite, , France

Site Status RECRUITING

Hôpital Nord, CHU de St Etienne

Saint-Priest-en-Jarez, , France

Site Status RECRUITING

Hôpital Nord-Ouest

Villefranche-sur-Saône, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie-Line Harlay

Role: CONTACT

04 72 11 28 62 ext. +33

Naoual EL JONHY

Role: CONTACT

0472356912 ext. +33

Facility Contacts

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Thomas BOCHATON

Role: primary

04 72 35 75 41 ext. +33

Maxime DUMESNIL

Role: primary

04 73 75 07 50 ext. +33

Alexandre LAUTRETTE

Role: primary

04 73 27 80 80 ext. +33

Jean-Pierre QUENOT

Role: primary

03 80 29 37 51 ext. +33

Carole SCHWEBEL

Role: primary

04 76 76 87 79 ext. +33

Marie-Line HARLAY

Role: primary

04 72 11 28 62 ext. +33

Laurent ARGAUD

Role: backup

04 72 11 28 62 ext. +33

Emmanuel VIVIER

Role: primary

04 78 61 82 09 ext. +33

Marc GAINNIER

Role: primary

04 91 38 85 50 ext. +33

Kada KLOUCHE

Role: primary

04 67 33 77 36 ext. +33

Claire ROGER

Role: primary

04 66 68 33 31 ext. +33

Sebastian VOICU

Role: primary

01 49 95 84 42 ext. +33

Auguste DARGENT

Role: primary

04 78 86 21 18 ext. +33

Guillaume THIERY

Role: primary

04 77 12 78 62 ext. +33

Julien ILLINGER

Role: primary

04 74 09 29 31 ext. +33

Other Identifiers

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2023-A01315-40

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL21_0001

Identifier Type: -

Identifier Source: org_study_id

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