REmote COnditioning in Out-of-Hospital Cardiac Arrest

Official title

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

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.

Interventions

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

Primary outcome measures

• All cause of death [Time frame: 72 hours after hospital admission]
• Multiple organ failure [Time frame: 72 hours after hospital admission]
• Severe neurological failure [Time frame: 72 hours after hospital admission]

Secondary outcome measures (12)

• Sepsis-related Organ Failure Assessment (SOFA) score [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 [Time frame: 24 hours after hospital admission]
• Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction [Time frame: 48 hours after hospital admission]
• Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction [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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

France · 14 centers

• Hôpital Louis Pradel — Bron
• Hôpital Gabriel Montpied, CHU de Clermont Ferrand — Clermont-Ferrand
• Centre Jean Perrin, Clermont-Ferrand — Clermont-Ferrand
• Hôpital F Mitterrand, CHU de Dijon — Dijon
• Hôpital Albert Michallon, CHU de Grenoble — La Tronche
• Hôpital Edouard Herriot — Lyon
• Hôpital Saint-Joseph Saint-Luc — Lyon
• Hôpital de la Timone, CHU de Marseille — Marseille
• … and 6 more centers

Identifiers

NCT: NCT06306625 · 69HCL21_0001 · 2023-A01315-40

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗