Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 10:34 AM
Study NCT ID:
NCT03860467
Status:
COMPLETED
Last Update Posted:
2022-06-02
First Post:
2019-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epileptic Seizures in Intensive Care Units
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D013226', 'term': 'Status Epilepticus'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2019-02-26', 'studyFirstSubmitQcDate': '2019-02-27', 'lastUpdatePostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of epileptic seizures', 'timeFrame': 'between 01.01.2005 and 19.12.2018', 'description': 'Frequency of all epileptic seizures in the ICU'}], 'secondaryOutcomes': [{'measure': 'Number of epileptic seizures captured by EEG', 'timeFrame': 'between 01.01.2005 and 19.12.2018', 'description': 'Number of epileptic seizures captured by EEG without overt clinical seizure presentation in the ICU'}, {'measure': 'Number of epileptic seizures diagnosed on the basis of clinical symptoms alone', 'timeFrame': 'between 01.01.2005 and 19.12.2018', 'description': 'Number of epileptic seizures diagnosed on the basis of clinical symptoms alone in the ICU'}, {'measure': 'Length of epileptic seizure (time)', 'timeFrame': 'between 01.01.2005 and 19.12.2018', 'description': 'Duration of epileptic seizure'}, {'measure': 'Semiological feature of epileptic seizure (i.e. seizure types)', 'timeFrame': 'between 01.01.2005 and 19.12.2018', 'description': 'Semiological feature of epileptic seizure (i.e. seizure types) emerging in ICU-patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Status epilepticus', 'Electroencephalogram', 'Intensive Care Unit'], 'conditions': ['Epileptic Seizure']}, 'referencesModule': {'references': [{'pmid': '35235003', 'type': 'DERIVED', 'citation': 'Wagner AS, Semmlack S, Frei A, Ruegg S, Marsch S, Sutter R. Seizures and risks for recurrence in critically ill patients: an observational cohort study. J Neurol. 2022 Aug;269(8):4185-4194. doi: 10.1007/s00415-022-11038-6. Epub 2022 Mar 2.'}]}, 'descriptionModule': {'briefSummary': 'This retrospective observational cohort study is to assess and analyze clinical, electroencephalographic, laboratory, comorbidity, and treatment characteristics of Intensive care unit (ICU)-patients with epileptic seizures and to subsequently compare their characteristics with ICU-patients with status epilepticus (SE).', 'detailedDescription': 'The aim of this retrospective observational cohort study is to get further insight into adult patients with epileptic seizures in ICUs in an academic tertiary medical care center regarding frequency, clinical and electroencephalogram (EEG) characteristics, treatment, course and outcome. This data could help understanding the epidemiology (including risk factors, influence of EEG), and to guide management and improve outcomes of affected patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients (i.e., ≥18 years of age) admitted to the ICUs at the University Hospital Basel that suffered from one or more epileptic seizures (detected clinically and/or by EEG) during their ICU-stay', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admitted to the ICU at the University Hospital Basel\n* suffered from one or more epileptic seizures (detected clinically and/or by EEG) during their ICU-stay\n\nExclusion Criteria:\n\n* patients with epileptic seizures transforming into Status epilepticus (SE)'}, 'identificationModule': {'nctId': 'NCT03860467', 'briefTitle': 'Epileptic Seizures in Intensive Care Units', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Epileptic Seizures in Intensive Care Units', 'orgStudyIdInfo': {'id': '2018-02361; me19Sutter'}}, 'armsInterventionsModule': {'interventions': [{'name': 'collection of patient data', 'type': 'OTHER', 'description': 'Patient data will be collected using the in-house digital patient record systems and the local digital electroencephalogram (EEG)-database'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Clinic for Intensive Care Medicine, University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Raoul Sutter, PD Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic for Intensive Care Medicine, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}