[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568411":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":60,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":31,"enrollmentInfo":77,"targetDuration":31,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":31,"overallStatus":44,"whyStopped":31,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Oregon Health and Science University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early Amiodarone Protocol","EXPERIMENTAL","Amiodarone administration after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine.",[13],"Drug: Amiodarone Hydrochloride Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care Protocol","ACTIVE_COMPARATOR","Amiodarone administration after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine.",[19],"Other: Usual Care Protocol",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Amiodarone Hydrochloride Injection","The use of a modified treatment protocol by emergency medical services where the initial dose of amiodarone is given after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine, for out-of-hospital cardiac arrest due to a shockable rhythm (ventricular fibrillation or ventricular tachycardia) that is persistent or recurs after at least one defibrillation attempt.\n\nIf an EMS agency is assigned to this arm, no downstream care after the initial dose of amiodarone is dictated by the study.",[9],[27],"Early-Amiodarone Protocol",{"type":6,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"The use of a usual care treatment protocol by emergency medical services where the initial dose of amiodarone is given after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine, for out-of-hospital cardiac arrest due to a shockable rhythm (ventricular fibrillation or ventricular tachycardia) that is persistent or recurs after at least one defibrillation attempt.\n\nIf an EMS agency is assigned to this arm, no downstream care after the initial dose of amiodarone is dictated by the study.",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Joshua Lupton, MD, MPH","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":31,"email":40},"CONTACT","(503) 418-6706","lupton@ohsu.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Oregon Health & Sciences University","RECRUITING","Portland","Oregon","97035","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-122.67621,45.52345,{"lat":54,"lon":53},[57,59],{"name":34,"role":38,"phone":58,"phoneExt":31,"email":40},"503-418-6706",{"name":34,"role":35,"phone":31,"phoneExt":31,"email":31},{"type":35,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Joshua Lupton","Principal Investigator",[64],{"name":65,"class":66},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100568411","phase-3-early-amiodarone-in-shockable-cardiac-arrest-100568411",false,"NCT06680869","Early Amiodarone in Shockable Cardiac Arrest","Early Amiodarone in Shockable Cardiac Arrest (Early-Amio) Study","Early-Amio","Inclusion Criteria:\n\n* Emergency medical services (EMS)-treated non-traumatic out-of-hospital cardiac arrest\n* Initial rhythm on EMS rhythm assessment of ventricular fibrillation or ventricular tachycardia\n* Recurrence or persistence of ventricular fibrillation or ventricular tachycardia after one defibrillation attempt\n\nExclusion Criteria:\n\n* Known allergy to amiodarone\n* EMS-assessed contraindication to amiodarone\n* Pre-existing \"do-not-attempt-resuscitation\" orders\n* Inter-facility transportations\n* Initial care by a non-participating EMS agency able to perform advanced life support interventions\n* Pediatric patient as determined by EMS\n* Prisoners\n* Pregnant patients","ALL","18 Years",{"count":78,"type":79},585,"ESTIMATED","INTERVENTIONAL",[82],"PHASE3","The primary objective of this pilot, pragmatic stepped-wedge cluster randomized trial is to evaluate if a modified cardiac arrest treatment algorithm calling for the administration of the initial amiodarone dose one 2-minute cycle earlier than current guidelines (during the same cycle as the initial dose of epinephrine) improves the time to amiodarone delivery in those with out-of-hospital cardiac arrest due to refractory ventricular fibrillation or ventricular tachycardia compared to usual care.",[85],"Cardiac Arrest","2025-12-17",{"date":88,"type":89},"2025-12-19","ACTUAL",{"date":91,"type":89},"2025-01-01",{"date":93,"type":79},"2028-01-31",{"name":5,"class":6},1]