Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-03 @ 7:22 AM
Study NCT ID:
NCT03276650
Status:
COMPLETED
Last Update Posted:
2018-09-20
First Post:
2017-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Admission of Adult-onset Still Disease Patients in the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016706', 'term': "Still's Disease, Adult-Onset"}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-19', 'studyFirstSubmitDate': '2017-08-25', 'studyFirstSubmitQcDate': '2017-09-07', 'lastUpdatePostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients', 'timeFrame': 'At inclusion', 'description': 'Number of patients fulfilling the inclusion criteria'}], 'secondaryOutcomes': [{'measure': 'APACHE II', 'timeFrame': '24hour after ICU admission', 'description': 'Acute Physiologic Assessment and Chronic Health Evaluation II'}, {'measure': 'Mortality', 'timeFrame': 'through study completion, maximum 17,5 years after admission', 'description': 'Kaplan Meier'}, {'measure': 'Number of rehospitalisation in ICU', 'timeFrame': 'through study completion, maximum 17,5 years after admission', 'description': 'need for critical care after the first hospitalisation in ICU'}, {'measure': 'number of hospitalisation in internal medicine ward', 'timeFrame': 'through study completion, maximum 17,5 years after admission', 'description': 'number of hospitalisation in internal medicine ward after the first ICU stay'}, {'measure': 'recurrent relapses', 'timeFrame': 'through study completion, maximum 17,5 years after admission', 'description': 'number of recurrent flares after the first hospitalisation in ICU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adult-Onset Still Disease', 'Critically Ill']}, 'descriptionModule': {'briefSummary': "Since its first description in 1971, diagnosing adult-onset Still's disease (AOSD), a rare multisystemic disorder considered as a multigenic autoinflammatory syndrome, remains challenging. Rarely, AOSD may present severe systemic manifestations and require intensive care. The main purpose of the Stil ICU study is to make the first description of the epidemiology of critically ill AOSD patients. The investigators will use a retrospective cohort study design with dual recruitment strategies: (1) via the AOSD referral centres network and (2) via a French academic medical ICU network."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult AOSD patients admitted to ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AOSD (history of newly diagnosed)\n* ICU admission between January 2001 and June 2017\n\nExclusion Criteria:\n\n* adults under protection\n* admission in step-down unit'}, 'identificationModule': {'nctId': 'NCT03276650', 'acronym': 'Still-ICU', 'briefTitle': 'Admission of Adult-onset Still Disease Patients in the ICU', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Admission of Adult-onset Still Disease Patients in the ICU: a French Retrospective Multicentric Study', 'orgStudyIdInfo': {'id': 'PSS2017/Still-ICU-LEMARIE/VS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'critically ill AOSD patients', 'description': 'no intervention Data collection from hospitalisation reports (administrative, biological, clinical, outcome)', 'interventionNames': ['Other: data collection']}], 'interventions': [{'name': 'data collection', 'type': 'OTHER', 'description': 'biological, administrative, clinical, outcome date', 'armGroupLabels': ['critically ill AOSD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'CHRU', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}