Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-28 @ 12:12 PM
Study NCT ID:
NCT05841368
Status:
UNKNOWN
Last Update Posted:
2023-05-03
First Post:
2023-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DELIRIUM SCREENING, INCIDENCE AND MANAGEMENT OBSERVATIONAL STUDY IN 2024 - THE CZECH REPUBLIC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'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'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-22', 'studyFirstSubmitDate': '2023-04-22', 'studyFirstSubmitQcDate': '2023-04-22', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delirium prevalence', 'timeFrame': 'during 30 days after study initiation in selected ICU', 'description': 'Delirium prevalence by CAM-ICU and pCAM-ICU will be screened in defined time interval'}], 'secondaryOutcomes': [{'measure': 'Delirium management', 'timeFrame': 'during 30 days after study initiation in selected ICU', 'description': 'Management of delirium will be evaluated'}, {'measure': 'Inhospital mortality', 'timeFrame': 'during 30 days after study initiation in selected ICU', 'description': 'Inhospital mortality will be evaluated'}, {'measure': '28-days mortality', 'timeFrame': 'after patient inclusion into the study', 'description': '28-days mortality will be evaluated'}, {'measure': '90-days mortality', 'timeFrame': 'after patient inclusion into the study', 'description': 'long term mortality will be evaluated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delirium', 'Screening', 'Therapy', 'CAM-ICU'], 'conditions': ['Delirium']}, 'descriptionModule': {'briefSummary': 'Delirium in intensive care unit (ICU) settings is a frequent complication with reported prevalence of 31%. Recent data has revealed the connection between delirium and increased 30days mortality after hospital release and the higher incidence of readmission to emergency. Despite the high prevalence and well described validation methods for screening, the precise incidence remains unclear due to insufficient screening in ICU settings. The incidence of delirium in Czech Republic remains undescribed, beside data reported from neurointensive care patients and single-center general critically ill patients data.', 'detailedDescription': 'All patients fulfilling inclusion criteria in intensive care settings in involved ICUs in Czech Republic will be included into the study. Data will be recorded for 1 consequent month. Basic demography will be evaluated. In each patient standard delirium screening based on the institutional ICU rules will be performed. If no screening method were set,Confusion Assessment Method - CAM-ICU for adult and pediatric Confusion Assessment Method -pCAM-ICU for pediatric patients would be used together with delirium management, restrain procedures, sedative/neuroleptics administration, 28-days mortality. All data will be recorded into to predefined eCRF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ICU patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in ICU settings\n* in defined time interval of the study\n\nExclusion Criteria:\n\n* duration of ICU stay shorter than 24 hours'}, 'identificationModule': {'nctId': 'NCT05841368', 'acronym': 'DELUSION', 'briefTitle': 'DELIRIUM SCREENING, INCIDENCE AND MANAGEMENT OBSERVATIONAL STUDY IN 2024 - THE CZECH REPUBLIC', 'organization': {'class': 'OTHER', 'fullName': 'Brno University Hospital'}, 'officialTitle': 'DELIRIUM SCREENING, INCIDENCE AND MANAGEMENT OBSERVATIONAL STUDY IN 2024 - THE CZECH REPUBLIC', 'orgStudyIdInfo': {'id': 'DELUSION-24-CZ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult ICU patients', 'description': 'Adult patients in ICU setting', 'interventionNames': ['Diagnostic Test: CAM-ICU']}, {'label': 'Pediatric ICU patients', 'description': 'Pediatric patients in ICU setting', 'interventionNames': ['Diagnostic Test: pCAM-ICU']}], 'interventions': [{'name': 'CAM-ICU', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['delirium screening'], 'description': 'Delirium in adult patients will be screened according to CAM-ICU', 'armGroupLabels': ['Adult ICU patients']}, {'name': 'pCAM-ICU', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['delirium screening'], 'description': 'Delirium in adult patients will be screened according to pCAM-ICU', 'armGroupLabels': ['Pediatric ICU patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62500', 'city': 'Brno', 'state': 'South Moravian', 'country': 'Czechia', 'facility': 'Brno University Hospital', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'centralContacts': [{'name': 'Jozef UO Klučka, assoc.prof.MD., Ph.D.', 'role': 'CONTACT', 'email': 'klucka.jozef@fnbrno.cz', 'phone': '+420532234696'}, {'name': 'Jan Malaska, MD.PHD. EDIC', 'role': 'CONTACT', 'email': 'malaska.jan@fnbrno.cz', 'phone': '+420532234695'}], 'overallOfficials': [{'name': 'Petr Stourac, prof. MD., Ph.D., MBA', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of paediatric anaesthesia and intensive care medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brno University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Masaryk University', 'class': 'OTHER'}, {'name': 'Department of Neurology, University Hospital Brno', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Petr Štourač, MD', 'investigatorAffiliation': 'Brno University Hospital'}}}}