Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-02-22 @ 4:13 PM
Study NCT ID:
NCT06502912
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2024-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Iron Reserves and Perioperative Neurocognitive Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019190', 'term': 'Iron Overload'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12984}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2024-07-02', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with postoperative delirium', 'timeFrame': 'Within the first seven days following surgery', 'description': 'Medical chart review was used for postoperative delirium determination in this study. The defining criteria were as follows: 1) delirium-related terms included in postoperative medical records or 2) postoperative record of delirium or psychotropic drugs treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iron reserves', 'Perioperative neurocognitive disorders', 'elderly', 'iron overload'], 'conditions': ['Perioperative Neurocognitive Disorders']}, 'descriptionModule': {'briefSummary': 'Iron metabolism disorder have been identified as the pivotal contributor in the pathogenesis and progression of perioperative neurocognitive disorders. However, the association between iron reserves and perioperative neurocognitive disorders risk remains elusive. This retrospective cohort study aimed to explore the impact of preoperative serum ferritin levels on the risk of postoperative delirium in elderly patients undergoing non-neurosurgical and non-cardiac procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hospital based group', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Geriatric surgical patients ≥65 years old\n\nExclusion Criteria:\n\n* preoperative use of antipsychotics\n* diagnosis or history description of preoperative cognitive disorders including dementia and Parkinson's"}, 'identificationModule': {'nctId': 'NCT06502912', 'briefTitle': 'Association Between Iron Reserves and Perioperative Neurocognitive Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Association Between Iron Reserves and Perioperative Neurocognitive Disorders', 'orgStudyIdInfo': {'id': 'PLAGH-AOC-R02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'elderly patients (aged ≥ 65 years)', 'description': 'elderly patients undergoing non-neurosurgical and non-cardiac procedures', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['elderly patients (aged ≥ 65 years)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Weidong Mi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director (Cheif expert of National key research and development program of China 2018YFC2001900)', 'investigatorFullName': 'Weidong Mi', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}