Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-02-20 @ 7:23 PM
Study NCT ID:
NCT06680869
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2024-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Amiodarone in Shockable Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000638', 'term': 'Amiodarone'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 585}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from emergency medical services (EMS) arrival on-scene (or time of arrest if witnessed by EMS) to the administration of the initial dose of amiodarone in minutes', 'timeFrame': 'up to 1 day'}], 'secondaryOutcomes': [{'measure': 'The number and proportion of patients receiving the initial dose of amiodarone from emergency medical services before the third shock from a defibrillator', 'timeFrame': 'up to 1 day'}, {'measure': 'The number and proportion of patients with pulses present and documented by emergency medical services at the time of patient care transfer to hospital staff at emergency department arrival', 'timeFrame': 'up to 1 day'}, {'measure': 'The number and proportion of patients surviving to be admitted to inpatient services after arrival to the emergency department', 'timeFrame': 'up to 1 day'}, {'measure': 'The number and proportion of patients surviving to be discharged from the hospital (or 30 days, whichever is sooner) after their admission for cardiac arrest', 'timeFrame': 'up to 30 days'}, {'measure': 'The number and proportion of patients surviving to be discharged from the hospital (or 30 days, whichever is sooner) after their admission for cardiac arrest with a Cerebral Performance Category score of 1 or 2', 'timeFrame': 'up to 30 days', 'description': 'The Cerebral Performance Category (CPC) score scale is 1-5:\n\nCPC 1: Good cerebral performance: conscious, alert, able to work, might have mild neurologic or psychologic deficit.\n\nCPC 2: Moderate cerebral disability: conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment.\n\nCPC 3: Severe cerebral disability: conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis.\n\nCPC 4: Coma or vegetative state: any degree of coma without the presence of all brain death criteria. Unawareness, even if appears awake (vegetative state) without interaction with environment; may have spontaneous eye opening and sleep/awake cycles. Cerebral unresponsiveness.\n\nCPC 5: Brain death: apnea, areflexia, EEG silence, etc.'}, {'measure': 'Time from emergency medical services (EMS) arrival on-scene (or time of arrest if witnessed by EMS) to the delivery of other critical interventions in minutes', 'timeFrame': 'up to 1 day', 'description': 'Critical interventions include: the second-fourth defibrillator shocks, the first use of double sequential external defibrillation, the administration of the first two epinephrine doses, and the time to advanced airway placement by EMS.'}, {'measure': 'Number and proportion of participants with adverse events', 'timeFrame': 'up to 1 day', 'description': 'e.g.: malignant cardiac arrhythmia, allergic reaction, recurrent cardiac arrest'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ohsu.edu/school-of-medicine/emergency/early-amiodarone-shockable-cardiac-arrest-early-amio-study', 'label': 'Early-Amio Study Website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe null hypothesis is that there is no difference in time to amiodarone delivery, relative to emergency medical services (EMS) arrival on-scene or time of arrest if witnessed by EMS, in the modified protocol calling for earlier amiodarone administration compared to usual care.\n\nEvaluated secondary outcomes will include the proportion of patients receiving amiodarone before their third defibrillation, pulses present at emergency department arrival, survival to hospital discharge, neurologically intact survival at hospital discharge, timing to other critical EMS interventions, and clinical adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT06680869', 'acronym': 'Early-Amio', 'briefTitle': 'Early Amiodarone in Shockable Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Early Amiodarone in Shockable Cardiac Arrest (Early-Amio) Study', 'orgStudyIdInfo': {'id': 'STUDY00026455'}, 'secondaryIdInfos': [{'id': '1K23HL173647-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23HL173647-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Amiodarone Protocol', 'description': 'Amiodarone administration after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine.', 'interventionNames': ['Drug: Amiodarone Hydrochloride Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Protocol', 'description': 'Amiodarone administration after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine.', 'interventionNames': ['Other: Usual Care Protocol']}], 'interventions': [{'name': 'Amiodarone Hydrochloride Injection', 'type': 'DRUG', 'otherNames': ['Early-Amiodarone Protocol'], 'description': '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.', 'armGroupLabels': ['Early Amiodarone Protocol']}, {'name': 'Usual Care Protocol', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Usual Care Protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97035', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joshua Lupton, MD, MPH', 'role': 'CONTACT', 'email': 'lupton@ohsu.edu', 'phone': '503-418-6706'}, {'name': 'Joshua Lupton, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oregon Health & Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Joshua Lupton, MD, MPH', 'role': 'CONTACT', 'email': 'lupton@ohsu.edu', 'phone': '(503) 418-6706'}], 'overallOfficials': [{'name': 'Joshua Lupton, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Within 12 months from study completion. No end date.', 'ipdSharing': 'YES', 'description': 'A de-identified dataset will be shared with all data elements required for analysis, if de-identification is deemed feasible, with the NHLBI BioLINCC.', 'accessCriteria': 'Per NHLBI BioLINCC policy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joshua Lupton', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}