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To determine if prophylactic administration of amiodarone for 72 hours in critically ill patients admitted after an OHCA with shockable rhythm, with a confirmed or a presumed cardiac cause, decreases the incidence of a composite endpoint of 30-day (starting from inclusion) all-cause mortality and/or severe in-hospital ventricular arrhythmia recurrence (ventricular fibrillation and/or ventricular tachycardia requiring intervention including re-arrest)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amiodarone | Experimental | Initial loading dose of 300mg over 30 minutes in 250ml of glucose 5% solution. Continuous amiodarone infusion will be administered for 72 hours at a dose of 10 mg/kg without exceeding 900 mg/24h. |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amiodarone | Drug | Initial loading dose of 300mg over 30 minutes in 250ml of glucose 5% solution. Continuous amiodarone infusion will be administered for 72 hours at a dose of 10 mg/kg without exceeding 900 mg/24h. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Mortality and severe ventricular arrhythmia | The primary endpoint is a composite of 30-day (starting from inclusion) all-cause mortality and occurrence of severe in-hospital ventricular arrhythmia, defined by ventricular fibrillation and/or ventricular tachycardia requiring intervention occurring between inclusion and hospital discharge (or 30-day whichever the sooner). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| outcomes related with cardiac events |
| 90 days |
| outcomes related with mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandrine Roux | Contact | 0139239777 | sroux@ght78sud.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Amiens | Not yet recruiting | Amiens | France |
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|
| 90 days |
| Duration of invasive mechanical ventilation | 90 days |
| Number of participants with outcomes related with amiodorane side effects | Number of the following side effects, patients could experimente (if applicable) during amiodarone infusion:
| 5 days |
| Neurological outcome | M-Rankin scale (the lowest score is no handicap and the highest score is death) and Glasgow Outcome Score (the lowest score is the most severe coma) | 90 days |
| Duration vasopressor infusion | 90 days |
| Length of ICU stay | 90 days |
| Length of stay in hospital | 90 days |
| Dose of the anti-arrhythmic drugs | 90 days |
| Number of days of anti-arrhythmic drugs | 90 days |
| Chu Angers | Recruiting | Angers | France |
|
| CH annecy genevois | Recruiting | Annecy | France |
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| Ch Argenteuil | Recruiting | Argenteuil | France |
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| CH Mondor | Recruiting | Aurillac | France |
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| CHU Brest | Recruiting | Brest | France |
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| CH Brive | Recruiting | Brive-la-Gaillarde | France |
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| Chu Caen | Not yet recruiting | Caen | France |
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| Chi Nord Ardennes | Recruiting | Charleville-Mézières | France |
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| CHSF | Recruiting | Corbeil-Essonnes | France |
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| CHD vendée | Recruiting | La Roche-sur-Yon | France |
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| CH la rochelle | Recruiting | La Rochelle | France |
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| Hcl | Recruiting | Lyon | France |
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| Ap Hm | Recruiting | Marseille | France |
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| Hopital Cartier | Recruiting | Massy | France |
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| chi Gregoire | Not yet recruiting | Montreuil | France |
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| Hoptial Mulhouse | Recruiting | Mulhouse | France |
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| CHU Nantes | Not yet recruiting | Nantes | France |
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| Clinique Ambroise Paré | Recruiting | Neuilly-sur-Seine | France |
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| CHU Nice -MIR Archet | Recruiting | Nice | France |
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| CHU Nice -MIR Pasteur | Recruiting | Nice | France |
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| Chu Orléans | Recruiting | Orléans | France |
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| CHU Cochin | Recruiting | Paris | France |
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| Hopital saint joseph | Recruiting | Paris | France |
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| CHU Poitiers | Recruiting | Poitiers | France |
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| Chu Strasbourg | Recruiting | Strasbourg | France |
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| CHI Toulon | Recruiting | Toulon | France |
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| Chu Toulouse | Recruiting | Toulouse | France |
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| CH Cotentin | Recruiting | Valognes | France |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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