Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-03 @ 12:27 PM
Study NCT ID:
NCT05454228
Status:
UNKNOWN
Last Update Posted:
2023-01-18
First Post:
2022-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers and Postoperative Delirium in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': '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': 400}, 'targetDuration': '5 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-16', 'studyFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2022-07-08', 'lastUpdatePostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neuroinflammatory biomarkers', 'timeFrame': 'preoperative、24 hours after surgery、48 hours after surgery', 'description': 'Whether there are changes in neuroinflammatory biomarkers(Ykl40(pg/mL), procalcitonin(ng/mL), IL-17A,IL-23,INF-γ(IU), Tau(pg/mL), amyloid beta(pg/mL),etc) in cerebrospinal fluid and plasma between delirium patients and non-delirium patients before and after operation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Delirium']}, 'descriptionModule': {'briefSummary': 'This study intends to verify and explore the correlation of neuroinflammation biomarkers in cerebrospinal fluid and plasma of elderly patients undergoing hip replacement with postoperative delirium, so as to achieve a new method to predict whether patients will develop postoperative delirium and improve the prognosis of elderly patients with postoperative delirium. Reduce the probability of postoperative complications, improve the long-term survival rate of patients after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Elderly patients undergoing hip replacement surgery in Henan Provincial People's Hospital were selected during the trial", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age≥65\n2. Patients undergoing hip replacement under spinal anesthesia\n3. ASA grade I\\~III;\n4. Voluntarily participate in this study, and informed consent was signed by the patients themselves and their families\n\nExclusion Criteria:\n\n1. Patients with multiple fractures and trauma\n2. Patients with preoperative cognitive dysfunction determined by MMSE scale;\n3. Severe impairment of hearing, visual and language system functions;\n4. Not suitable for or unwilling to undergo subarachnoid anesthesia\n5. Patients who refuse to participate or cannot cooperate.'}, 'identificationModule': {'nctId': 'NCT05454228', 'briefTitle': 'Biomarkers and Postoperative Delirium in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': "Henan Provincial People's Hospital"}, 'officialTitle': 'Relationship Between Neuroinflammatory Biomarkers and Postoperative Delirium in Elderly Patients With Hip Replacement', 'orgStudyIdInfo': {'id': 'biomarkers'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Delirium', 'interventionNames': ['Behavioral: postoperative delirium']}, {'label': 'Non-delirium', 'interventionNames': ['Behavioral: postoperative delirium']}], 'interventions': [{'name': 'postoperative delirium', 'type': 'BEHAVIORAL', 'description': 'Postoperative delirium (POD) occurs within 1 week after surgery in patients, with obvious time characteristics, mainly occurring within 1-3 days after surgery. Postoperative delirium has adverse effects on the short and long term prognosis of patients. Patients with delirium have an increased risk of postoperative complications, perioperative death, longer hospital stay and increased medical costs during hospitalization.', 'armGroupLabels': ['Delirium', 'Non-delirium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhaoyu Wen', 'role': 'CONTACT'}], 'facility': "Henan People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Zhaoyu Wen, Bachelor', 'role': 'CONTACT', 'email': '76338445@qq.com', 'phone': '0086-18860371522'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}