Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-04 @ 8:50 AM
Study NCT ID:
NCT06672159
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2024-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Double Sequential External Defibrillation in Out of Hospital Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-12', 'size': 1475408, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-30T17:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All included ambulance stations will perform one of the two procedures for six months followed by a crossover for six months.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 356}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of patient-related adverse effects.', 'timeFrame': '365 days', 'description': 'Measure/obtain information regarding adverse effects experience by patient using DSED procedure.'}, {'measure': 'Incidence of malfunction of defibrillator.', 'timeFrame': '365 days', 'description': 'Assess information regarding occurrence of defibrillator damage after DSED procedure.'}], 'primaryOutcomes': [{'measure': 'Proportion of patients that survive to hospital admission.', 'timeFrame': '24 hours', 'description': 'Number of patients arriving with ROSC in hospital emergency facility.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients that survive for 30 days', 'timeFrame': '30 days', 'description': 'Number of patients that have survived OHCA incident after 30 days.'}, {'measure': 'Review of 30 day neurological status.', 'timeFrame': '30 days', 'description': 'Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA.'}, {'measure': 'Proportion of patients that survive for 90 days', 'timeFrame': '90 days', 'description': 'Number of patients that have survived OHCA incident after 90 days.'}, {'measure': 'Review 90 day neurological status.', 'timeFrame': '90 days', 'description': 'Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA.'}, {'measure': 'Proportion of patients that survive for one year.', 'timeFrame': '365 days', 'description': 'Number of patients that have survived OHCA incident after 365 days.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Double defibrillation', 'Cardiopulmonary resuscitation'], 'conditions': ['Cardiac Arrest', 'Out-Of-Hospital Cardiac Arrest', 'Ventricular Fibrillation']}, 'descriptionModule': {'briefSummary': 'Double Sequential External Defibrillation (DSED) represents an alternative treatment of refractory ventricular fibrillation (rVF) in out-of-hospital cardiac arrest (OHCA). The procedure consists of two defibrillators that administer shocks at the same time.\n\nCurrently, the procedure is not initiated before at least three failed attempts with one defibrillator. This can delay the potential benefits of establishing DSED earlier in the treatment. Studies have shown that early defibrillation is crucial for survival in OHCA patients, and in 2022, a clinical trial showed that survival in patients treated with DSED was higher compared to standard treatment.\n\nThe effect of initiating OHCA treatment is unknown. The DUALDEFIB trial seeks to investigate if treating OHCA patients with DSED as an initial treatment will increase survival and provide improved neurological outcome.', 'detailedDescription': 'The project is investigator-initiated, prospective, two-group randomized controlled trial (RCT). Prior to the RCT, a pilot feasibility trial of 3-4 months will be performed, including three ambulance bases in mid-Norway. All OHCA patients will be included until validity and feasibility of the study is accomplished. The pilot study will be followed by the RCT.\n\nOutcome measurements in the RCT are aimed to be the same as in the pilot study. Ambulance bases will be randomized to either DSED or standard procedure for six months before crossover with the other treatment for six months.\n\nAmbulances included in the project will carry two defibrillators. Both defibrillators will be established for initial defibrillation with DSED in OHCA patients. The pads are placed in anterior-lateral position (standard placement) and anterior-posterior position (over sternum and beneath left scapula). Shocks are administered in rapid succession with less than one second apart. All other treatment will be according to existing guidelines.\n\nThe included patients are OHCA patients with age over 18 years presenting with a shockable rhythm. Excluded patients are patients with obvious or suspected pregnancy, incarcerated patients or patients with no-resuscitation order. The patients that meet the inclusion criteria will be registered by the ambulance personnel through a secure webpage.\n\nPrimary outcome is survival to hospital admission.\n\nSecondary outcomes are survival to hospital discharge, 30 days, 90 days and 1 year survival, in addition to neurological status.\n\nPatients from the pilot will be included in the RCT intervention group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with out of hospital cardiac arrest presenting with a shockable rhythm\n\nExclusion Criteria:\n\n* Age below 18 years\n* Obvious or suspected pregnancy\n* Incarcerated patients\n* Preexisting do-not-resuscitate order'}, 'identificationModule': {'nctId': 'NCT06672159', 'acronym': 'DUALDEFIB', 'briefTitle': 'Initial Double Sequential External Defibrillation in Out of Hospital Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'A Randomized Controlled Trial on Early Double External Sequential Defibrillation in Out of Hospital Cardiac Arrest', 'orgStudyIdInfo': {'id': '724951'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Double sequential external defibrillation', 'description': 'Patient will receive first shock using two defibrillators. All other aspects of resuscitation in accordance to existing guidelines.', 'interventionNames': ['Device: Two defibrillators']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment', 'description': 'Standard treatment in accordance to existing Advanced Cardiopulmonary Resuscitation-guidelines using one defibrillator in anterior-lateral placement.', 'interventionNames': ['Device: One defibrillator']}], 'interventions': [{'name': 'Two defibrillators', 'type': 'DEVICE', 'description': 'DSED procedure consists of pads placed in anterior-lateral position, and in anterior-posterior position. Defibrillations will be given in rapid sequence, less than a second apart. All other aspects of resuscitation in accordance to existing guidelines.', 'armGroupLabels': ['Double sequential external defibrillation']}, {'name': 'One defibrillator', 'type': 'DEVICE', 'description': 'Standard OHCA treatment according to existing guidelines.', 'armGroupLabels': ['Standard treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7030', 'city': 'Trondheim', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Jostein R Brede, MD, PhD', 'role': 'CONTACT', 'email': 'jostein.brede@norskluftambulanse.no'}, {'name': 'Vegard Nordviste, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'centralContacts': [{'name': 'Jostein R Brede, MD', 'role': 'CONTACT', 'email': 'jostein.brede@norskluftambulanse.no', 'phone': '+47 99445914'}, {'name': 'Vegard Nordviste, MD, PhD', 'role': 'CONTACT', 'email': 'vegard.nordviste@norskluftambulanse.no'}], 'overallOfficials': [{'name': 'Kjetil Karlsen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St. Olavs Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Study protocol and ICF will be available before study start. SAP will be available before first interim analysis.', 'ipdSharing': 'YES', 'description': 'The full study protocol, statistical analysis plan, information letter for consent and other trial documents will be published open access. The clinical study report and statistical analysis report will also be made openly available but may be altered to hide information that may lead to identification of individual study participants.', 'accessCriteria': 'Individual level data will be made available to sponsor institutions. Access will be controlled by a data processor agreement between the partner and funder. De-identified individual level data collected during the trial, will be made available on request to researchers from other scientific institutions by approval of the project management to ensure that usage is compliant with privacy and consent requirements as well as conditions for attribution and usage. Data sharing with editors or peer-reviewers of scientific journals, conferences or the like will not require additional consent or data access agreement with sponsor, as such data will not be shared onward or used beyond reviewing this trial.\n\nAfter data sharing, the sponsor must be acknowledged in any publication resulting from the shared data. For closer collaboration attribution based on the Vancouver Convention will apply.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Air Ambulance Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}