Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-09 @ 7:37 AM
Study NCT ID:
NCT06447805
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2024-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Double Sequential 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': 'D014693', 'term': 'Ventricular Fibrillation'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], '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'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-23', 'size': 4097971, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-11T04:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Academic, investigator initiated, open-label pilot study with a randomized controlled trial (RCT) design and 3:1 allocation (3 intervention: 1 standard).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of early double sequential external defibrillation (DSD)', 'timeFrame': 'day 1', 'description': 'Number of EMS defibrillations prior to randomization (target \\> 80% before third defibrillation)'}, {'measure': 'Adherence to double sequential external defibrillation (DSD)', 'timeFrame': 'day 1', 'description': 'Among patients randomized to DSD, proportion that received DSD (target \\> 80%)'}, {'measure': 'Cross-over', 'timeFrame': 'day 1', 'description': 'Among patients randomized to standard, proportion that received DSD (target \\< 10%)'}, {'measure': 'Feasibility of double sequential external defibrillation (DSD)', 'timeFrame': 'day 1', 'description': 'Proportion of eligible patients included and randomized (target \\> 80%)'}, {'measure': 'Safety of double sequential external defibrillation', 'timeFrame': 'day 1', 'description': 'Major adverse events (e.g. defibrillator malfunction)'}, {'measure': 'Safety of CPR during double sequential external defibrillation', 'timeFrame': 'day 1', 'description': 'Chest compression fraction (hands off time during CPR, target \\> 80% in both groups)'}], 'secondaryOutcomes': [{'measure': 'Return of spontaneous circulation (ROSC)', 'timeFrame': 'day 1', 'description': 'Proportion of patients with sustained return of spontaneous circulation (ROSC) at hospital arrival'}, {'measure': 'Number of defibrillations to sustained ROSC', 'timeFrame': 'day 1', 'description': 'Total number of defibrillations to sustained ROSC'}, {'measure': 'Survival to hospital admission', 'timeFrame': 'day 1', 'description': 'Pateint is admitted to hospital alive'}, {'measure': 'Survival to discharge', 'timeFrame': 'day 1-180', 'description': 'Survival to hospital discharge'}, {'measure': '30 day survival', 'timeFrame': 'day 30', 'description': 'Survival at 30 days'}, {'measure': 'Neurological function at 30 days', 'timeFrame': 'day 30', 'description': 'Neurological function (modified Rankin Scale, mRS 1-6, and Cerebral Performance Category, CPC 1-5) at 30 days'}, {'measure': 'Neurological function and Health related Quality of life at 90 and 180 days', 'timeFrame': 'day 90 and 180', 'description': 'Neurological function (modifiied Rankin Scale and Cerebral Performance Category) and Health-related Quality of life at 90 and 180 days (CPC 1-5, mRS 1-6)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary resuscitation', 'Defibrillation', 'Double sequential defibrillation'], 'conditions': ['Cardiac Arrest', 'Fibrillation, Ventricular', 'Sudden Cardiac Death', 'Sudden Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '36342151', 'type': 'RESULT', 'citation': 'Cheskes S, Verbeek PR, Drennan IR, McLeod SL, Turner L, Pinto R, Feldman M, Davis M, Vaillancourt C, Morrison LJ, Dorian P, Scales DC. Defibrillation Strategies for Refractory Ventricular Fibrillation. N Engl J Med. 2022 Nov 24;387(21):1947-1956. doi: 10.1056/NEJMoa2207304. Epub 2022 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'Some of the patients affected by Out-of-hospital cardiac arrest (OHCA) with ventricular fibrillation (VF)/ventricular tachycardia (VT) do not respond to initial defibrillation. The survival decreases with number of defibrillations required to terminate VF/VT. In 2022, one prospective cluster randomized trial showed increased survival among (OHCA) patients in refractory VF using Double Sequential Defibrillation (DSD).\n\nTo evaluate feasibility and safety this randomized pilot trial will compare the effect of double defibrillation strategy initiated as soon as possible after the first defibrillation with continued resuscitation using standard defibrillation, in patients with Out of Hospital Cardiac arrest (OHCA). The results from this pilot trial will form the basis for design of a larger multicenter survival study.', 'detailedDescription': 'The Dubbel-D study is an academic, investigator initiated, open-label pilot study with a randomized controlled trial (RCT) design conducted in the prehospital emergency medical services, i.e. ambulance organizations. The trial will be conducted by participating ambulance units attending OHCA´s. These units will perform screening for inclusion, randomization, intervention or control treatment and initial follow-up.\n\nIn all cases of OHCA a defibrillator should always be attached with the standard pad placement, anterio-lateral (A-L) position first. This is in accordance with standard of care. If there is VT/VF or an automated external defibrillator (AED) suggests defibrillation, defibrillation should be performed, and immediate chest compressions resumed. Thereafter, the patient can be screened for inclusion. If two study specific defibrillators (Corpulse 3) on site and no exclusion criteria (age below 18 years, obvious pregnancy, known preexisting Do Not Attempt Resuscitation order) the patient can be included and randomized.\n\nRandomization will be performed by drawing a scratch-card with concealed allocation that will be stored with the EMS defibrillators. All scratch-cards will be pre-randomized in a 3:1 ratio in blocks consisting of 4-8-12 and stratified by region and ambulance provider.\n\nIf the patient is randomized to the intervention group, the ambulance crew team will apply the second defibrillator with electrodes placed in the anterio-posterior (A-P) position as soon as possible. Defibrillation is performed by one person defibrillating both defibrillators in a sequential manner "Double Sequential Defibrillation" (DSD). All consecutive defibrillations will thereafter be performed with the DSD strategy until ROSC, termination of resuscitation or decision to move the patient to hospital.\n\nIf randomized to the control group, the ambulance crew team will continue Advanced Life Support (ACLS) in accordance with standard of care. Defibrillation is performed with standard electrode placement (A-L position) using a single defibrillator. If an AED is the first defibrillator attached to the patient, the ambulance crew should shift from an AED to their own manual defibrillator, but the mode of defibrillation should remain in A-L position and only one defibrillator should be used for each defibrillation and continue until ROSC, termination of resuscitation or decision to move the patient to hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Out-of-Hospital patients with Ventricular Fibrillation/ Ventricular Tachycardia at rhythm analysis after ambulance arrival and at least one defibrillation performed in standard (Antero-Lateral) position\n\nExclusion Criteria:\n\n* Age below 18 years\n* Obvious pregnancy\n* Known preexisting Do Not Attempt Resuscitation order'}, 'identificationModule': {'nctId': 'NCT06447805', 'acronym': 'DOUBLE-D', 'briefTitle': 'Early Double Sequential Defibrillation in Out-of-hospital Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': '"A Pilot Study Assessing Feasibility of a Randomized Trial Comparing the Effect of Early Double Sequential Defibrillation as Soon as Possible in OHCA With a Shockable Rhythm (VT/VF) Compared to Standard Defibrillation"', 'orgStudyIdInfo': {'id': 'CIV-ID-24-01-045759'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Double Sequential Defibrillation (DSD)', 'description': 'If the patient is randomized to the DSD group, the ambulance crew team will apply the second defibrillator with electrodes placed in the A-P position as soon as possible.\n\nDefibrillation is performed by one person defibrillating both defibrillators in a sequential manner "Double Sequential Defibrillation" (DSD). All consecutive defibrillations will thereafter be performed with the DSD strategy until ROSC, termination of resuscitation or decision to move the patient to hospital.', 'interventionNames': ['Device: Double Sequential Defibrillation (DSD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard defibrillation', 'description': 'If the patient is randomized to the standard defibrillation group, the ambulance crew team will continue Advanced life support in accordance with standard of care and continue to perform standard defibibrillation using one defibrillator. All consecutive defibrillations will thereafter be performed with the standard defibrillation strategy until ROSC, termination of resuscitation or decision to move the patient to hospital.', 'interventionNames': ['Device: Standard defibrillation']}], 'interventions': [{'name': 'Double Sequential Defibrillation (DSD)', 'type': 'DEVICE', 'description': 'The second defibrillator will be applyed with electrodes placed in the A-P position', 'armGroupLabels': ['Double Sequential Defibrillation (DSD)']}, {'name': 'Standard defibrillation', 'type': 'DEVICE', 'description': 'Standard defibrillation uning one defibrillator', 'armGroupLabels': ['Standard defibrillation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30238', 'city': 'Halmstad', 'state': 'Halland County', 'country': 'Sweden', 'facility': 'Emergency medical services Region Halland', 'geoPoint': {'lat': 56.67446, 'lon': 12.85676}}, {'zip': '411 04', 'city': 'Gothenburg', 'state': 'Västra Götalandsregionen', 'country': 'Sweden', 'facility': 'Sahlgrenska Universitetssjukhuset, Ambulans och Prehospital Akutsjukvård', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '441 39', 'city': 'Alingsås', 'state': 'Västra Götalandsregionen', 'country': 'Sweden', 'facility': 'Sjukhusen i väster, ambulanssjukvården Alingsås/Lerum', 'geoPoint': {'lat': 57.93033, 'lon': 12.53345}}], 'overallOfficials': [{'name': 'Gabriel Riva, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Akil Awad, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Andreas Claesson, RN, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Carl Magnusson, RN, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sahlgrenska University'}, {'name': 'Leif Svensson, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Johan Israelsson, RN, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Linné University'}, {'name': 'Emma Blick-Nordqvist, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Martin Jonsson, Msc, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Jacob Hollenberg, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Sheldon Cheskes, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, M.D., Ph.D. Center for resuscitation Scinence', 'investigatorFullName': 'Gabriel Riva', 'investigatorAffiliation': 'Karolinska Institutet'}}}}