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

Civil Hospices of Lyon

Status: Enrolling

Conditions: Out-Of-Hospital Cardiac Arrest

Treatments: Device: Remote ischemic conditioning; Device: No remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT06306625

69HCL21_0001

2023-A01315-40 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Remote ischemic conditioning

Experimental group

Description:

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.

Treatment:

Device: Remote ischemic conditioning

Control group

Other group

Description:

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

Treatment:

Device: No remote ischemic conditioning