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NCT Number: NCT06306625

REmote COnditioning in Out-of-Hospital Cardiac Arrest

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.

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Louis Pradel, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

remote ischemic conditioning

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.

No remote ischemic conditioning

Device

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

Primary outcomes

  1. All cause of death

    Time frame: 72 hours after hospital admission

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

  2. Multiple organ failure

    Time frame: 72 hours after hospital admission

    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.

  3. Severe neurological failure

    Time frame: 72 hours after hospital admission

    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.

Secondary outcomes

  1. Sepsis-related Organ Failure Assessment (SOFA) score

    Time frame: 24 hours after hospital admission

    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).

  2. Sepsis-related Organ Failure Assessment (SOFA) score

    Time frame: 48 hours after hospital admission

    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).

  3. Sepsis-related Organ Failure Assessment (SOFA) score

    Time frame: 72 hours after hospital admission

    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).

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

    Time frame: 24 hours after hospital admission

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

    Time frame: 48 hours after hospital admission

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

    Time frame: 72 hours after hospital admission

  7. Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction

    Time frame: 24 hours after hospital admission

    Average SOFA sub-scores for each organ failure scored from 0 to 4 points

  8. Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction

    Time frame: 48 hours after hospital admission

    Average SOFA sub-scores for each organ failure scored from 0 to 4 points

  9. Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction

    Time frame: 72 hours after hospital admission

    Average SOFA sub-scores for each organ failure scored from 0 to 4 points

  10. 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)

  11. 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)

  12. 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

  13. 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

  14. Serum level of neuron-specific enolase (NSE)

    Time frame: Between 48 and 72 hours after hospital admission

  15. Cerebral Performance Categories (CPC) scale

    Time frame: Day 90

    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).

  16. All-cause mortality

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Line Harlay

CONTACT

[email protected]

04 72 11 28 62 ext. +33

Naoual EL JONHY

CONTACT

[email protected]

0472356912 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: RECO-OHCA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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