Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-05 @ 2:30 AM
Study NCT ID:
NCT04168268
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2019-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-reported Outcome Measures After Post-anesthesia Care Unit Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}], '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': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-16', 'studyFirstSubmitDate': '2019-11-16', 'studyFirstSubmitQcDate': '2019-11-16', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported cognitive failures', 'timeFrame': 'three months', 'description': 'Cognitive Failures Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Health-related quality of life', 'timeFrame': 'three months', 'description': 'Short Form Health Survey 36'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium', 'Neurocognitive Disorders']}, 'referencesModule': {'references': [{'pmid': '35084649', 'type': 'DERIVED', 'citation': 'Kainz E, Stuff K, Kahl U, Wiessner C, Yu Y, von Breunig F, Nitzschke R, Haese A, Graefen M, Fischer M. Impact of postanesthesia care unit delirium on self-reported cognitive function and perceived health status: a prospective observational cohort study. Qual Life Res. 2022 Aug;31(8):2397-2410. doi: 10.1007/s11136-022-03087-1. Epub 2022 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'To assess self-reported cognitive function and health-related quality of life in patients with and without early postoperative delirium', 'detailedDescription': 'Neurocognitive disorders including postoperative delirium are a serious complication after surgery and anesthesia in the elderly. Postoperative delirium is an acute-onset diffuse brain dysfunction that is characterized by a fluctuating course of confusion, disorganized thinking, inattention, irritability, disturbances of the circadian rhythm, and disorders of consciousness. Post-anesthesia care unit (PACU) delirium occurs immediately after emergence from anesthesia and affects up to 45% of patients after elective surgery.\n\nIt is unclear, whether PACU delirium is associated with intermediated or long-term adverse outcomes including neurocognitive disorders or mortality. The aim of this prospective observational was to assess self-reported cognitive function and health-related quality of life in patients with and without PACU delirium three months after radical prostatectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for elective radical prostatectomy for prostate cancer at a high-volume prostate cancer center were screened on the day before surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective radical prostatectomy\n* \\>60 years\n* fluent in German\n\nExclusion Criteria:\n\n* preexisting cognitive impairment\n* cerebrovascular disease'}, 'identificationModule': {'nctId': 'NCT04168268', 'briefTitle': 'Patient-reported Outcome Measures After Post-anesthesia Care Unit Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Influence of Post-anesthesia Care Unit Delirium After Radical Prostatectomy on Self-reported Cognitive Function and Health-related Quality of Life', 'orgStudyIdInfo': {'id': 'PACU-DE'}}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Department of Anesthesiology, University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}