REmote COnditioning in Out-of-Hospital Cardiac Arrest

Hospices Civils de Lyon220 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

220

Conditions

Out-Of-Hospital Cardiac Arrest

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (14)

Hôpital Louis Pradel

Bron, France

NOT_YET_RECRUITING

Hôpital Gabriel Montpied, CHU de Clermont Ferrand

Clermont-Ferrand, France

NOT_YET_RECRUITING

Centre Jean Perrin, Clermont-Ferrand

Clermont-Ferrand, France

NOT_YET_RECRUITING

Hôpital F Mitterrand, CHU de Dijon

Dijon, France

NOT_YET_RECRUITING

Hôpital Albert Michallon, CHU de Grenoble

La Tronche, France

NOT_YET_RECRUITING

Hôpital Edouard Herriot

Lyon, France

RECRUITING

Hôpital Saint-Joseph Saint-Luc

Lyon, France

RECRUITING

Hôpital de la Timone, CHU de Marseille

Marseille, France

RECRUITING

Hôpital lapeyronie, CHU de Montpellier

Montpellier, France

RECRUITING

Hôpital Universitaire Carémeau

Nîmes, France

NOT_YET_RECRUITING

...and 4 more locations

Outcomes

Primary Outcomes

All cause of death

All-cause death will be assessed 72 hours after hospital admission.

Time frame: 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.

Time frame: 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.

Time frame: 72 hours after hospital admission

Secondary Outcomes

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).

Time frame: 24 hours after hospital admission

Sepsis-related Organ Failure Assessment (SOFA) score

Time frame: 48 hours after hospital admission

Sepsis-related Organ Failure Assessment (SOFA) score

Time frame: 72 hours after hospital admission

Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score

Time frame: 24 hours after hospital admission

Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score

Time frame: 48 hours after hospital admission

Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 72 hours after hospital admission

Mean Sepsis-related Organ Failure Assessment (SOFA) score

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: Between hospital admission to 24 hours, admission to 48 hours and admission to 72 hours

Serum level of neuron-specific enolase (NSE)

Time frame: 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).

Time frame: Day 90

All-cause mortality

Time frame: From date of randomization until day 90 after hospital admission

REmote COnditioning in Out-of-Hospital Cardiac Arrest

Overview

Conditions

Interventions

Eligibility

Locations (14)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts