REmote COnditioning in Out-of-Hospital Cardiac Arrest

Out-Of-Hospital Cardiac Arrest Clinical Trial

— RECO-OHCA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06306625
• Other study ID #: 69HCL21_0001
• Secondary ID: 2023-A01315-40
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: August 15, 2026

Study information

• Verified date: March 2024
• Source: Hospices Civils de Lyon
• Contact: Marie-Line Harlay
• Phone: 04 72 11 28 62
• Email: marie-line.harlay[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: August 15, 2026
• Est. primary completion date: May 4, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 another interventional study with an exclusion period still in progress at pre-inclusion.

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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.
• No remote ischemic conditioning
A brachial cuff is positioned around the arm of the patient and no inflation or deflation is performed.

Locations

Country	Name	City	State
France	Hôpital Louis Pradel	Bron
France	Centre Jean Perrin, Clermont-Ferrand	Clermont-Ferrand
France	Hôpital Gabriel Montpied, CHU de Clermont Ferrand	Clermont-Ferrand
France	Hôpital F Mitterrand, CHU de Dijon	Dijon
France	Hôpital Albert Michallon, CHU de Grenoble	La Tronche
France	Hôpital Edouard Herriot	Lyon
France	Hôpital Saint-Joseph Saint-Luc	Lyon
France	Hôpital de la Timone, CHU de Marseille	Marseille
France	Hôpital lapeyronie, CHU de Montpellier	Montpellier
France	Hôpital Universitaire Carémeau	Nîmes
France	Hôpital Lyon-Sud	Pierre-Bénite
France	Hôpital Nord, CHU de St Etienne	Saint-Priest-en-Jarez
France	Hôpital Nord-Ouest	Villefranche-sur-Saône

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause of death	All-cause death will be assessed 72 hours after hospital admission.	72 hours after hospital admission
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score		24 hours after hospital admission
Secondary	Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score		48 hours after hospital admission
Secondary	Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score		72 hours after hospital admission
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	Serum level of neuron-specific enolase (NSE)		Between 48 and 72 hours after hospital admission
Secondary	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
Secondary	All-cause mortality		From date of randomization until day 90 after hospital admission