Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 8:15 PM
Study NCT ID:
NCT05105906
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2021-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-operative Delirium (POD) in Patients Undergoing Hip Fracture Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2021-10-25', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appearance of POD within the first 3 months', 'timeFrame': '3 months assessment', 'description': 'Appearance of Post Operative Delirium within the first 3 months after hip surgery'}], 'secondaryOutcomes': [{'measure': 'Development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time', 'timeFrame': '12 months assessment', 'description': 'Development of Post Operative Cognitive Dysfunction, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium', 'Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'The primary endpoint of the study is the appearance of Post Operative Delirium within the first 3 months.\n\nThe secondary endpoints are the development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time (including rehabilitation performed within the Polyclinic).. The analysis of the risk factors of POD and their correlation with the development of POCD/Dementia in the post-surgery period will provide important information for the optimization of the management path of these patients at an individual level , with inevitable repercussions on the possibility of reintegration into social and family life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All men and women over the age of 65 with clinical-radiological hip fracture presence will be enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 65\n* Clinical - radiological presence of hip fracture\n\nExclusion Criteria:\n\n* Age \\<65'}, 'identificationModule': {'nctId': 'NCT05105906', 'briefTitle': 'Post-operative Delirium (POD) in Patients Undergoing Hip Fracture Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Post-operative Delirium (POD) Assessment in Patients Undergoing Hip Fracture Surgery', 'orgStudyIdInfo': {'id': 'FPG ID 3993'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cognitive tests performed', 'type': 'DIAGNOSTIC_TEST', 'description': 'cognitive tests performed'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Policlinico Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Giuliano Ferrone', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Giuliano Ferrone', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}