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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01315-40 | Other Identifier | ID-RCB |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control group | Other | A brachial cuff is positioned around one arm of the patient. Neither inflation nor deflation is performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All cause of death | All-cause death will be assessed 72 hours after hospital admission. | 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. | 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. | 72 hours after hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Line Harlay | Contact | 04 72 11 28 62 | +33 | marie-line.harlay@chu-lyon.fr |
| Naoual EL JONHY | Contact | 0472356912 | +33 | naoual.el-jonhy@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Louis Pradel | Not yet recruiting | Bron | 69500 | France |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| No remote ischemic conditioning | Device | A brachial cuff is positioned around the arm of the patient and no inflation or deflation is performed. |
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| 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 |
| 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 |
| Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score | 24 hours after hospital admission |
| Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score | 48 hours after hospital admission |
| Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score | 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 | 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 | 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 | 72 hours after hospital admission |
| 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) |
| 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) |
| 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 |
| 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 |
| Serum level of neuron-specific enolase (NSE) | 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). | Day 90 |
| All-cause mortality | From date of randomization until day 90 after hospital admission |
| Hôpital Gabriel Montpied, CHU de Clermont Ferrand | Not yet recruiting | Clermont-Ferrand | 63000 | France |
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| Centre Jean Perrin, Clermont-Ferrand | Not yet recruiting | Clermont-Ferrand | 69300 | France |
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| Hôpital F Mitterrand, CHU de Dijon | Not yet recruiting | Dijon | 21079 | France |
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| Hôpital Albert Michallon, CHU de Grenoble | Not yet recruiting | La Tronche | 38700 | France |
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| Hôpital Edouard Herriot | Recruiting | Lyon | 69003 | France |
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| Hôpital Saint-Joseph Saint-Luc | Recruiting | Lyon | 69007 | France |
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| Hôpital de la Timone, CHU de Marseille | Recruiting | Marseille | 13385 | France |
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| Hôpital lapeyronie, CHU de Montpellier | Recruiting | Montpellier | 34295 | France |
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| Hôpital Universitaire Carémeau | Not yet recruiting | Nîmes | 30029 | France |
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| Hôpital Lariboisière, APHP, Réanimation Médicale et Toxicologique | Not yet recruiting | Paris | 75010 | France |
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| Hôpital Lyon-Sud | Recruiting | Pierre-Bénite | 69310 | France |
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| Hôpital Nord, CHU de St Etienne | Recruiting | Saint-Priest-en-Jarez | 42270 | France |
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| Hôpital Nord-Ouest | Recruiting | Villefranche-sur-Saône | 69655 | France |
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