Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-01 @ 9:00 PM
Study NCT ID:
NCT05839418
Status:
RECRUITING
Last Update Posted:
2023-05-03
First Post:
2023-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013226', 'term': 'Status Epilepticus'}], 'ancestors': [{'id': 'D012640', 'term': 'Seizures'}, {'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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2023-04-20', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Rankin Scale', 'timeFrame': 'On the date of discharge from hospital or date of death from any cause, assessed up to 24 months', 'description': 'Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).'}, {'measure': 'Refractoriness', 'timeFrame': 'From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months', 'description': 'Refractory Status Epilepticus is defined as Status Epilepticus persisting despite administration of at least two appropriately selected and dosed parenteral medications including a benzodiazepine.'}], 'secondaryOutcomes': [{'measure': 'Modified Rankin Scale', 'timeFrame': 'At 30 days after the date of inclusion or SE onset (if still hospitalized)', 'description': 'Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).'}, {'measure': 'Modified Rankin Scale', 'timeFrame': 'At 3 months after the date of discharge from hospital', 'description': 'Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).'}, {'measure': 'Super-refractoriness', 'timeFrame': 'From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months', 'description': 'Super-refractory status epilepticus is defined as Status Epilepticus persisting or recurring after 24 hours or more of treatment with continuous intravenous anesthetic drugs or when therapy is tapered after 24 hours of use.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Status Epilepticus']}, 'referencesModule': {'references': [{'pmid': '38178048', 'type': 'DERIVED', 'citation': 'Damien C, Leitinger M, Kellinghaus C, Strzelczyk A, De Stefano P, Beier CP, Sutter R, Kamppi L, Strbian D, Tauboll E, Rosenow F, Helbok R, Ruegg S, Damian M, Trinka E, Gaspard N. Sustained effort network for treatment of status epilepticus/European academy of neurology registry on adult refractory status epilepticus (SENSE-II/AROUSE). BMC Neurol. 2024 Jan 4;24(1):19. doi: 10.1186/s12883-023-03505-y.'}]}, 'descriptionModule': {'briefSummary': 'SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.', 'detailedDescription': 'SENSE-II/AROUSE is a prospective, multicenter, non-randomized, observational registry study of consecutive cases of SE. We aimed to include university hospitals as well as non-university hospitals to enhance generalizability of the findings.\n\nCurrently, 13 high-volume medical centers in Belgium, Austria, Germany, United Kingdom, Switzerland, No common management protocol will be imposed on the participating centers. However, most institutions have established a local protocol that is closely related to the most recent guidelines for the management of SE published by the American Epilepsy Society (AES) in 2016.\n\nWe will exclude patients with anoxic status epilepticus after cardiac arrest and patients younger than 18 years.\n\nClinical and EEG Data will be collected prospectively from the admission of the patient to the discharge. Data collection will be performed using Research Electronic Data Capture (REDCap) electronic data capture tools hosted at Erasme Hospital in Brussels, Belgium.\n\nTo reach sufficient statistical power for multivariate analysis, a cohort size of 3000 patients is targeted.\n\nThe main objective of the study is to document patient characteristics, treatment modalities, EEG features and outcome of adults treated for SE and identify predictors of outcome. The data collected in this study could also identify gaps and opportunities for the management of this medical emergency. Lacking adequate prospective controlled trials, this will help both decision-making in clinical practice and designing future clinical trials.\n\nMoreover, EEG data will help for a better electroencephalographic definition of SE, possible SE, and some boundary conditions, such as ictal-interictal continuum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients of and above 18 years admitted for Status Epilepticus management or who develop Status Epilepticus during their hospital stay', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or above\n* Patients admitted for management of Status Epilepticus as their primary diagnosis\n* Patients admitted for another primary diagnosis but identified with Status Epilepticus during their acute hospital stay\n\nExclusion Criteria:\n\n\\- Patients with post-cardiac arrest SE'}, 'identificationModule': {'nctId': 'NCT05839418', 'acronym': 'SENSEII/AROUSE', 'briefTitle': 'Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)', 'orgStudyIdInfo': {'id': 'P2020/483/B4062020000170'}}, 'contactsLocationsModule': {'locations': [{'city': 'Linz', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Raimund Helbok, MD, PhD', 'role': 'CONTACT', 'email': 'raimund.helbok@tirol-kliniken.at'}, {'name': 'Raimund Helbok, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kepler University Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Salzburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Markus Leitinger, MD, PhD', 'role': 'CONTACT', 'email': 'ma.leitinger@salk.at'}, {'name': 'Eugen Trinka, MD, PhD', 'role': 'CONTACT', 'email': 'eugen@trinka.at'}, {'name': 'Markus Leitinger, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eugen Trinka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Christian Doppler Klinik of Paracelsus Medical University', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1070', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Nicolas Gaspard, MD, PhD', 'role': 'CONTACT', 'email': 'Nicolas.Gaspard@hubruxelles.be', 'phone': '00325553429'}, {'name': 'Charlotte Damien, MD', 'role': 'CONTACT', 'email': 'Charlotte.Damien@hubruxelles.be', 'phone': '00325553429'}, {'name': 'Charlotte Damien, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nicolas Gaspard, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HUB Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Christoph Beier, MD', 'role': 'CONTACT', 'email': 'Christoph.Beier@rsyd.dk'}, {'name': 'Christop Beier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Odense University Hospital & Svenborg Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Helsinki', 'status': 'NOT_YET_RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Daniel Strbian, MD', 'role': 'CONTACT', 'email': 'Daniel.strbian@hus.fi'}, {'name': 'Leena Kampii, MD', 'role': 'CONTACT', 'email': 'Leena.kamppi@hus.fi'}, {'name': 'Daniel Strbian, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Leena Kampii, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nina Forss, MS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Frankfurt', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Adam Strzelczyk, MD', 'role': 'CONTACT', 'email': 'strzelczyk@med.uni-frankfurt.de'}, {'name': 'Felix Rosenow, MD', 'role': 'CONTACT', 'email': 'Felix.Rosenow@kgu.de'}, {'name': 'Adam Strzelczyk, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Felix Rosenow, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Goethe-Universität Frankfurt am Main', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': 'D-49078', 'city': 'Osnabrück', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christoph Kellinghaus, MD', 'role': 'CONTACT', 'email': 'Christoph.Kellinghaus@klinikum-os.de'}, {'name': 'Christoph Kellinghaus, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Epilepsy Center Münster-Osnabrück, Klinikum Osnabrück', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'city': 'Oslo', 'status': 'NOT_YET_RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Erik Taubøll, MD', 'role': 'CONTACT', 'email': 'erik.tauboll@medisin.uio.no'}, {'name': 'Erik Taubøll, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Basel', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Stephan Rueegg, MD', 'role': 'CONTACT', 'email': 'stephan.rueegg@usb.ch'}, {'name': 'Raoul Sutter, MD', 'role': 'CONTACT', 'email': 'raoul.sutter@usb.ch'}, {'name': 'Stephan Rueegg, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Raoul Sutter, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Geneva', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Pia De Stefano, MD', 'role': 'CONTACT', 'email': 'Pia.deStefano@hcuge.ch'}, {'name': 'Pia De Stefano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Birmingham', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Maxwell Damian, MD', 'role': 'CONTACT', 'email': 'msdd2@cam.ac.uk'}, {'name': 'Maxwell Damian, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Birmingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'centralContacts': [{'name': 'Nicolas Gaspard, MD, PhD', 'role': 'CONTACT', 'email': 'Nicolas.Gaspard@erasme.ulb.ac.be', 'phone': '00325553429'}, {'name': 'Charlotte Damien, MD', 'role': 'CONTACT', 'email': 'Charlotte.Damien@erasme.ulb.ac.be', 'phone': '00325553429'}], 'overallOfficials': [{'name': 'Nicolas Gaspard, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasme UH'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data will be deidentified and collected through RedCap by each local investigator.\n\nIPD will be accessible and shared only with the researchers involved in this registry.\n\nThese de-identified data will be available for the duration of the registry and on reasonable request to Nicolas Gaspard after publication of the results.', 'ipdSharing': 'YES', 'description': 'All collected IPD will be shared with other researchers. not public upon reasonable request', 'accessCriteria': 'IPD will be accessible only by the researchers involved in the building of this registry.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}