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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505349-26-00 | EU Trial (CTIS) Number |
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This study will test whether a lower dose of epinephrine (0.5 mg) given during emergency treatment for out-of-hospital cardiac arrest helps more patients survive with good brain function, compared to the standard dose (1 mg). Adults who experience cardiac arrest outside the hospital and are treated by emergency medical teams will be randomly assigned to receive either the low dose or the standard dose of epinephrine. The study will compare survival and neurological outcomes between the two groups over 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation | Experimental | Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation |
|
| Epinephrine 1 mg IV bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation | Active Comparator | Epinephrine 1 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinephrine 0.5 mg intravenous bolus | Drug | Epinephrine 0.5 mg/mL solution for injection, administered as a 0.5 mg intravenous bolus every 3 to 5 minutes during cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest. T |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) score | The mRS score is a validated score measuring neurologic outcomes after cardio-pulmonary resuscitation (CPR) :
| 28-day |
| Measure | Description | Time Frame |
|---|---|---|
| Return of Spontaneous Circulation (ROSC). | Return of Spontaneous Circulation (ROSC) during cardiopulmonary resuscitation, defined as clinical signs of life including palpable pulse or blood pressure. | Periprocedural period of cardiopulmonary resuscitation |
| Vital status |
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Inclusion Criteria:
Male or female, aged ≥18 years. Out-of-hospital cardiac arrest for which resuscitation is decided by the SMUR team.
Medical Out-of-hospital cardiac arrest. Affiliated with or beneficiary of a social security plan
Exclusion Criteria:
Non-medical Out-of-hospital cardiac arrest (traumatic, drownings, electrocution, asphyxia, overdose, unknown cause).
Out-of-hospital cardiac arrest without advanced life support (Do Not Attempt Resuscitation order, body finding, the decision not to attempt advanced life support is at the physician's discretion).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tahar CHOUIHED, MD, PhD | Contact | 0033383157322 | T.CHOUIHEDMAHJOUB@chru-nancy.fr | |
| Nicolas Girerd, MD PhD | Contact | 0033383157322 | n.girerd@chru-nancy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Annecy | Annecy | France |
|
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| Epinephrine 1 mg intravenous bolus | Drug | Epinephrine 1 mg/mL solution for injection, administered as a 1 mg intravenous bolus every 3 to 5 minutes during cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest. |
|
Survival at hospital admission. |
| Periprocedural period of cardiopulmonary resuscitation |
| vital status | 28-day survival | 28 days post-cardiac arrest |
| Modified Rankin Scale (mRS) score. | Modified Rankin Scale (mRS) score used as a continuous variable (in contrast with the use of the mRS scale in the primary outcome). The mRS score is a validated score measuring neurologic outcomes after cardio-pulmonary resuscitation (CPR) :
| 28 days post-cardiac arrest |
| Centre hospitalier de la Côte Basque | Bayonne | France |
|
| CHU Besancon | Besançon | France |
|
| CHU Brest | Brest | France |
|
| CHU Colmar | Colmar | France |
|
| CH SUD Francilien | Corbeil-Essonnes | France |
|
| Brigade de Sapeurs-Pompiers de Paris | Courbevoie | France |
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| Centre Hospitalier Universitaire Grenoble Alpes | La Tronche | France |
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| Hospices Civils De Lyon | Lyon | France |
| CHU Montpellier | Montpellier | France |
|
| CHRU Nancy | Nancy | France |
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| Centre Hospitalier Universitaire De Nantes | Nantes | France |
|
| CHU Nice | Nice | France |
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| CHU Nimes | Nîmes | France |
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| AP-HP Hôpital Necker | Paris | France |
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| Hopital Beaujon | Paris | France |
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| hôpital Lariboisière | Paris | France |
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| La Pitié Salpêtrière | Paris | France |
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| Raymond Poincaré Hospital | Paris | France |
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| CHU Poitiers | Poitiers | France |
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| Centre Hospitalier Universitaire Reims | Reims | France |
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| CHU Rennes | Rennes | France |
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| CHU Rouen | Rouen | France |
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| Centre hospitalier Annecy Genevois Site Julien en GENEVOIS | Saint-Julien-en-Genevois | France |
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| Centre Hospitalier Universitaire De Toulouse | Toulouse | France |
|
| CHU Tours | Tours | France |
|
| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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