Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-04 @ 8:50 AM
Study NCT ID:
NCT02951793
Status:
UNKNOWN
Last Update Posted:
2021-08-20
First Post:
2016-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abuse and Addiction in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013375', 'term': 'Substance Withdrawal Syndrome'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'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'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2016-10-30', 'lastUpdatePostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delirium during ICU stay', 'timeFrame': 'From date of ICU admission until the date of ICU discharge, whichever came first, assessed up to 3 months'}], 'secondaryOutcomes': [{'measure': 'ICU length of stay', 'timeFrame': 'From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months'}, {'measure': 'Mortality', 'timeFrame': 'From date of ICU admission until the date of death, assessed up to 3 months', 'description': 'Death in MICU'}, {'measure': 'Maximal doses of dexmedetomidine', 'timeFrame': 'From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months'}, {'measure': 'Cumulative dose of dexmedetomidine', 'timeFrame': 'From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months', 'description': "Cumulative dose of dexmedetomidine during the patient's MICU stay"}, {'measure': 'Cumulative dose of midazolam', 'timeFrame': 'From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months', 'description': "Cumulative dose of midazolam during the patient's MICU stay"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intensive care unit', 'delirium', 'substance withdrawal'], 'conditions': ['Substance Withdrawal Syndrome']}, 'descriptionModule': {'briefSummary': 'Investigators are seeking to determine the impact of recent alcohol, smoking or psychotropic drug use prior to intensive care unit (ICU) admission on incidence of delirium and sedation requirements.\n\nStudy design: A prospective observational study, in a medical ICU of a tertiary university hospital.\n\nMethods: For all new ICU admissions, a 1-page questionnaire including Alcohol Use Disorders Identification Test (AUDIT-C), smoking history and prior medication use was given to the patient or closest family members.\n\nDelirium was assessed by trained ICU nurses using Intensive Care Delirium Screening Checklist and Richmond Agitation-Sedation Scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For all new ICU admissions above age of 18 years, except for those who fulfill exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are older than 18 years of age\n* New patients admitted to medical ICU for the 1st time during their stay in hospital\n\nExclusion Criteria:\n\n* Had history of stroke or other primary neurologic disease\n* GCS ≤ 8 prior to ICU admission\n* Transferred from other ICU (except for emergency ICU stay which is limited to less than 36 hours)\n* Not registered within 24 hours after admission\n* Refused to participate\n* If comatous state persists\n* Delirium assessment is not possible due to newly developed neurologic disease, such as cerebral infarction\n* Medical ICU stay less than 24 hours\n* Readmission to medical ICU'}, 'identificationModule': {'nctId': 'NCT02951793', 'briefTitle': 'Abuse and Addiction in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of Recent Alcohol, Smoking and Psychotropic Drug Use on Delirium in ICU', 'orgStudyIdInfo': {'id': 'addiction742'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AUDIT-C > 4', 'description': 'Significant alcohol use within 1 year prior to ICU admission (AUDIT-C\\>4)', 'interventionNames': ['Other: AUDIT-C']}, {'label': 'AUDIT-C <=4', 'description': 'No significant alcohol use within 1 year prior to ICU admission (AUDIT-C: equal or less than 4)', 'interventionNames': ['Other: AUDIT-C']}, {'label': 'Smoking history positive last year', 'description': 'Who smoke cigarette within 1-year prior to ICU admission', 'interventionNames': ['Other: Smoking history']}, {'label': 'Smoking history negative last year', 'description': 'Who did not smoke cigarette within 1-year prior to ICU admission', 'interventionNames': ['Other: Smoking history']}, {'label': 'Prior psychotropic medication use - yes', 'description': 'Who used psychotropic medication within 1-year prior to ICU admission', 'interventionNames': ['Other: Prior psychotropic medication use']}, {'label': 'Prior psychotropic medication use - no', 'description': 'Who did not use psychotropic medication within 1-year prior to ICU admission', 'interventionNames': ['Other: Prior psychotropic medication use']}], 'interventions': [{'name': 'AUDIT-C', 'type': 'OTHER', 'otherNames': ['Alcohol Use Disorders Identification Test'], 'description': 'Patients or their proxy/closest family member(s) undergo a comprehensive questionnaire including AUDIT-C about his/her alcohol behavior during last year and will be categorized into two groups: Those with AUDIT-C\\>4 versus AUDIT-C of 4 or below.', 'armGroupLabels': ['AUDIT-C <=4', 'AUDIT-C > 4']}, {'name': 'Smoking history', 'type': 'OTHER', 'description': 'Patients or their proxy/closest family member(s) undergo a comprehensive questionnaire including smoking history during last year and will be categorized into two groups: Current smoker versus ex- or never smoker (we also recorded smoking pack-years to distinguish heavy smokers)', 'armGroupLabels': ['Smoking history negative last year', 'Smoking history positive last year']}, {'name': 'Prior psychotropic medication use', 'type': 'OTHER', 'description': 'Patients or their proxy/closest family member(s) undergo a comprehensive questionnaire including psychotropic medication use prior admission to ICU and will be categorized into two groups: Those who use psychotropic medication versus those who do not use psychotropic medication.', 'armGroupLabels': ['Prior psychotropic medication use - no', 'Prior psychotropic medication use - yes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jinwoo Lee, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Jungsil Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jinwoo Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}