Out-Of-Hospital Cardiac ArrestRECO-OHCANCT06306625
REmote COnditioning in Out-of-Hospital Cardiac Arrest
A study testing Remote ischemic conditioning and No remote ischemic conditioning in people with Out-Of-Hospital Cardiac Arrest, run by Hospices Civils de Lyon at 14 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Remote ischemic conditioning and No remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 14 sitesFrance
- Study dates
- 21 Jun 2024to 5 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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 locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
France14 sites, 14 recruiting
- Not yet recruiting
Hôpital Louis Pradel
Bron, 69500
Thomas BOCHATON, 04 72 35 75 41 ext. +33, thomas.bochaton@chu-lyon.fr
Thomas BOCHATON
- Not yet recruiting
Hôpital Gabriel Montpied, CHU de Clermont Ferrand
Clermont-Ferrand, 63000
Maxime DUMESNIL, 04 73 75 07 50 ext. +33, mdumesnil@chu-clermontferrand.fr
Maxime DUMESNIL
- Not yet recruiting
Centre Jean Perrin, Clermont-Ferrand
Clermont-Ferrand, 69300
Alexandre LAUTRETTE, 04 73 27 80 80 ext. +33, alautrette@chu-clermontferrand.fr
Alexandre LAUTRETTE
- Not yet recruiting
Hôpital F Mitterrand, CHU de Dijon
Dijon, 21079
Jean-Pierre QUENOT, 03 80 29 37 51 ext. +33, jean-pierre.quenot@chu-dijon.fr
Jean-Pierre QUENOT
- Not yet recruiting
Hôpital Albert Michallon, CHU de Grenoble
La Tronche, 38700
Carole SCHWEBEL, 04 76 76 87 79 ext. +33, cschwebel@chu-grenoble.fr
Carole SCHWEBEL
- Recruiting
Hôpital Edouard Herriot
Lyon, 69003
Marie-Line HARLAY, 04 72 11 28 62 ext. +33, marie-line.harlay@chu-lyon.fr
Laurent ARGAUD, 04 72 11 28 62 ext. +33, laurent.argaud@chu-lyon.fr
- Recruiting
Hôpital Saint-Joseph Saint-Luc
Lyon, 69007
Emmanuel VIVIER, 04 78 61 82 09 ext. +33, evivier@ch-stjosephstluc-lyon.fr
Emmanuel VIVIER
- Recruiting
Hôpital de la Timone, CHU de Marseille
Marseille, 13385
Marc GAINNIER, 04 91 38 85 50 ext. +33, marc.gainnier@ap-hm.fr
Marc GAINNIER
- Recruiting
Hôpital lapeyronie, CHU de Montpellier
Montpellier, 34295
Kada KLOUCHE, 04 67 33 77 36 ext. +33, k-klouche@chu-montpellier.fr
Kada KLOUCHE
- Not yet recruiting
Hôpital Universitaire Carémeau
Nîmes, 30029
Claire ROGER, 04 66 68 33 31 ext. +33, claire.roger@chu-nimes.fr
Claire ROGER
- Not yet recruiting
Hôpital Lariboisière, APHP, Réanimation Médicale et Toxicologique
Paris, 75010
Sebastian VOICU, 01 49 95 84 42 ext. +33, sebastian.voicu@aphp.fr
Sebastian VOICU
- Recruiting
Hôpital Lyon-Sud
Pierre-Bénite, 69310
Auguste DARGENT, 04 78 86 21 18 ext. +33, auguste.dargent@chu-lyon.fr
Auguste DARGENT
- Recruiting
Hôpital Nord, CHU de St Etienne
Saint-Priest-en-Jarez, 42270
Guillaume THIERY, 04 77 12 78 62 ext. +33, guillaume.thiery@chu-st-etienne.fr
Guillaume THIERY
- Recruiting
Hôpital Nord-Ouest
Villefranche-sur-Saône, 69655
Julien ILLINGER, 04 74 09 29 31 ext. +33, jillinger@hno.fr
Julien ILLINGER
About this study
Official title: REmote Ischemic COnditioning in Out-of-Hospital Cardiac Arrest: The RECO-OHCA Study
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.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Remote ischemic conditioning, No remote ischemic conditioning
- Keywords
- Out-of-hospital cardiac arrest, remote conditioning, ischemic conditioning, ischemia-reperfusion, intensive care unit
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningDevice
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 conditioningDevice
A brachial cuff is positioned around the arm of the patient and no inflation or deflation is performed.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic conditioning | Experimental | 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. Receives: Device: Remote ischemic conditioning |
| Control group | Other | A brachial cuff is positioned around one arm of the patient. Neither inflation nor deflation is performed. Receives: Device: No remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause of death
All-cause death will be assessed 72 hours after hospital admission.
Measured: 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.
Measured: 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.
Measured: 72 hours after hospital admission
Secondary outcomes (16)
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).
Measured: 24 hours after hospital admission
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).
Measured: 48 hours after hospital admission
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).
Measured: 72 hours after hospital admission
Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score
Measured: 24 hours after hospital admission
Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score
Measured: 48 hours after hospital admission
Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score
Measured: 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
Measured: 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
Measured: 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
Measured: 72 hours after hospital admission
Mean Sepsis-related Organ Failure Assessment (SOFA) score
Measured: 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
Measured: 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)
Measured: 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
Measured: Between hospital admission to 24 hours, admission to 48 hours and admission to 72 hours
Serum level of neuron-specific enolase (NSE)
Measured: 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).
Measured: Day 90
All-cause mortality
Measured: From date of randomization until day 90 after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start21 Jun 2024
- Primary completion24 Jun 2026 (estimated)
- Study completion5 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306625
- Sponsor's protocol ID
- 69HCL21_0001
- Other IDs
- 2023-A01315-40
- Acronym
- RECO-OHCA
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REmote Ischemic COnditioning in Out-of-Hospital Cardiac Arrest: The RECO-OHCA Study
- ClinicalTrials.gov ID
- NCT06306625
- Acronym / sponsor ID
- RECO-OHCA / 69HCL21_0001
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Out-of-hospital cardiac arrest, remote conditioning, ischemic conditioning, ischemia-reperfusion, intensive care unit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 24 Jun 2026 (estimated)
- Study completion
- 5 Oct 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic conditioning | Experimental | Device: Remote ischemic conditioningA 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. |
| Control group | Other | Device: No remote ischemic conditioningA brachial cuff is positioned around one arm of the patient. Neither inflation nor deflation is performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioningA 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 | Remote ischemic conditioning |
| No remote ischemic conditioningA brachial cuff is positioned around the arm of the patient and no inflation or deflation is performed. | Device | Control group |
Primary outcome
All cause of death
Time frame: 72 hours after hospital admission
All-cause death will be assessed 72 hours after hospital admission.
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.
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.
16 secondary outcomes
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
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
Time frame: Day 90
All-cause mortality
Time frame: From date of randomization until day 90 after hospital admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning and No remote ischemic conditioning in people with Out-Of-Hospital Cardiac Arrest, run by Hospices Civils de Lyon at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Line Harlay (04 72 11 28 62 ext. +33, marie-line.harlay@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause of death (time frame: 72 hours after hospital admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.