Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-28 @ 7:23 PM
Study NCT ID:
NCT06131892
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defibrillation in Accidental Hypothermia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004554', 'term': 'Electric Countershock'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2023-10-22', 'studyFirstSubmitQcDate': '2023-11-12', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of patients with a core temperature equal or less than 30°C who had a successful defibrillation, defined as ROSC for at least 30 seconds', 'timeFrame': 'through study completion, an average of 3 months'}], 'secondaryOutcomes': [{'measure': 'the number of patients with a return to ventricular fibrillation after successful defibrillation', 'timeFrame': 'through study completion, an average of 3 months'}, {'measure': 'the rate of defibrillation attempts per patient', 'timeFrame': 'through study completion, an average of 3 months'}, {'measure': 'the number of patients with the presence of cardiac dysfunction after defibrillation', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'a decrease in cardiac output, or a reduced ejection fraction, systolic or diastolic dysfunction on echocardiographic ultrasound'}, {'measure': 'cerebral performance category (CPC) score of every patient at the end of hospitalization', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'a score from 1 to 5, with "1" meaning "Good Outcome", "5" means dead'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypothermia, Accidental', 'Defibrillation']}, 'descriptionModule': {'briefSummary': 'Hypothermia (core temperature ≤35°C) is a frequent and life-threatening complication after mountain accidents, near-drowning, and intoxications, and can provoke arrhythmia, reduced cardiac contractility, and cardiac arrest. The hypothermic heart may be insensitive to defibrillation with a core temperature \\<30°C. Also, below \\<30°C after successful defibrillation, a perfusing rhythm often degenerates to ventricular fibrillation (VF) again. Repeated defibrillation can induce myocardial injury. Thus, the guidelines of the European Resuscitation Council (ERC) suggest delaying further defibrillation attempts until the core temperature is \\>30°C if VF persists after 3 shocks. Epinephrine should be withheld if core temperature is \\<30°C. Advanced Life Support (ALS) guidelines of the American Heart Association (AHA) state that it may be reasonable to perform further defibrillation attempts according to the standard algorithm and to consider administration of a vasopressor during cardiac arrest (Table 1). This discrepancy between ERC and AHA guidelines can be explained by the different interpretations of mainly animal data, which show that vasopressors increase the chances of successful defibrillation \\<30°C, defined as return of spontaneous circulation (ROSC) for at least 30 seconds. The guidelines of the Wilderness and Environmental Medicine Society (WMS) state that a single shock at a maximum power can be given for patients with a temperature \\<30°C.\n\nThe aim of this study is to evaluate clinical course of hypothermic patients(\\<30°C) undergoing defibrillation. The primary aim is to evaluate the success ratio of defibrillation, defined as ROSC for at least 30 seconds. Secondary aims are the recurrence rate of ventricular fibrillation, the number of defibrillation attempts per patient, the presence of cardiac dysfunction after defibrillation and the cerebral performance category (CPC) score at the end of hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with accidental hypothermia and a body core temperature equal or less than 30°C who had one or more defibrillation attempts', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- patients of the International Hypothermia Registry with a defibrillation while having a body core temperature equal or less than 30°C\n\nExclusion Criteria:\n\n* patients of the International Hypothermia Registry with a body core temperature \\>30°C\n* patients who refused to participate'}, 'identificationModule': {'nctId': 'NCT06131892', 'briefTitle': 'Defibrillation in Accidental Hypothermia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Defibrillation in Accidental Hypothermia: a Retrospective Study of the International Hypothermia Registry', 'orgStudyIdInfo': {'id': '2023-01087'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Successful defibrillation during extra corporeal life support (ECLS) rewarming', 'interventionNames': ['Other: Defibrillation']}, {'label': 'Non Successful defibrillation during extra corporeal life support (ECLS) rewarming', 'interventionNames': ['Other: Defibrillation']}, {'label': 'Successful defibrillation before rewarming or during non-ECLS rewarming', 'description': 'non- ECLS: non- extra corporeal life support', 'interventionNames': ['Other: Defibrillation']}, {'label': 'Non- successful defibrillation before rewarming or during non-ECLS rewarming', 'description': 'non- ECLS: non- extra corporeal life support', 'interventionNames': ['Other: Defibrillation']}], 'interventions': [{'name': 'Defibrillation', 'type': 'OTHER', 'description': 'Defibrillation', 'armGroupLabels': ['Non Successful defibrillation during extra corporeal life support (ECLS) rewarming', 'Non- successful defibrillation before rewarming or during non-ECLS rewarming', 'Successful defibrillation before rewarming or during non-ECLS rewarming', 'Successful defibrillation during extra corporeal life support (ECLS) rewarming']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Division of Anaesthesiology', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Principal Investigator', 'investigatorFullName': 'Evelien Cools', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}