Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-29 @ 6:57 PM
Study NCT ID:
NCT05177159
Status:
UNKNOWN
Last Update Posted:
2023-02-15
First Post:
2018-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Delirium and Its Biomarkers in Elderly Patients Undergoing Non-cardiac and Non-neurosurgery.
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': 417}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2021-12-29', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of postoperative delirium within postoperative 5 days', 'timeFrame': 'the incidence of delirum within postoperative 5 days.', 'description': 'The postoperative delirium will be diagnosed if patients have fluctuation in mental status and attention and either thinking or consciousness in the past 24 hours as evidenced by fluctuation on Confusion Assessment Method-Intensive Care Unit (CAM-ICU) scale.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia', 'Postoperative Delirium']}, 'descriptionModule': {'briefSummary': 'Postoperative delirium (POD) is a common complication in elderly patients and is associated with negative clinical outcomes, such as prolonged hospitalizations, cognitive impairment, and higher mortality rate. While the pathophysiology of delirium remains unknown, the cerebral hypoperfusion and neuroinflammatory response are considered to play an important role in the process of POD. The aim of the study is to determine the association between POD and biomarkers in elderly patients undergoing noncardiac and non-neurological surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population will be selected from patients who schedule to receive elective non-cardiac and non-neurological surgery in Beijing Tiantan Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With American Society of Anesthesiologists (ASA) physical status Ⅱ-Ⅳ\n* Undergo elective non-cardiac and non-neurological surgery receiving general anesthesia\n* Operation time is expected to be longer than 2 hours\n\nExclusion Criteria:\n\n* Clinical diagnosis of dementia\n* Clinical diagnosis of cerebrovascular disorders\n* Clinical diagnosis of heart failure\n* Clinical diagnosis of liver failure\n* Clinical diagnosis of renal failure\n* Clinical diagnosis of traumatic brain injury\n* Alcohol abuse\n* Can not complete the cognitive assessments\n* Refuse to sign informed consent'}, 'identificationModule': {'nctId': 'NCT05177159', 'briefTitle': 'Postoperative Delirium and Its Biomarkers in Elderly Patients Undergoing Non-cardiac and Non-neurosurgery.', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Postoperative Delirium and Its Biomarkers in Elderly Patients Undergoing Non-cardiac and Non-neurosurgery: a Prospective Cohort Study.', 'orgStudyIdInfo': {'id': '2018-5-30'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Postoperative delirium', 'interventionNames': ['Other: The regional cerebral oxygen saturation (rSO2)', 'Other: The glial fibrillary acidic protein (GFAP)', 'Other: The brain-derived-neurotrophic factor (BDNF)']}, {'label': 'Non postoperative delirium', 'interventionNames': ['Other: The regional cerebral oxygen saturation (rSO2)', 'Other: The glial fibrillary acidic protein (GFAP)', 'Other: The brain-derived-neurotrophic factor (BDNF)']}], 'interventions': [{'name': 'The regional cerebral oxygen saturation (rSO2)', 'type': 'OTHER', 'description': 'Measurement of rSO2 with non-invasive near-infrared light spectrum monitor. The average, left and right frontal regions absolute rSO2 values will be collected every 30 seconds during the whole surgery until postoperative 2 hours, and the mean values will be calculated. Absolute rSO2 value and AUT (area under the threshold) send beneath the absolute threshold limits of 40%, 50% and 20%, 30% under the baseline. AUT will be calculated based on this formula: AUT (present)=AUT (past)+(rSO2 threshold-rSO2 value)×sample rate', 'armGroupLabels': ['Non postoperative delirium', 'Postoperative delirium']}, {'name': 'The glial fibrillary acidic protein (GFAP)', 'type': 'OTHER', 'description': 'Venous blood sample will be collected and tested for plasma GFAP. The blood will be collected 10 minutes before anesthesia, 30 minutes after intubation, every hour during operation, 15 minutes after extubation, and at 10:00 AM in postoperative 1,3,5 days.', 'armGroupLabels': ['Non postoperative delirium', 'Postoperative delirium']}, {'name': 'The brain-derived-neurotrophic factor (BDNF)', 'type': 'OTHER', 'description': 'Venous blood sample will be collected and tested for plasma BDNF. The blood will be collected 10 minutes before anesthesia, 30 minutes after intubation, every hour during operation, 15 minutes after extubation, and at 10:00 AM in postoperative 1,3,5 days.', 'armGroupLabels': ['Non postoperative delirium', 'Postoperative delirium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuming Peng', 'role': 'CONTACT'}], 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhengfang Hu, M.D., Ph.D', 'role': 'CONTACT', 'email': 'huzhengfang78@163.com', 'phone': '8610-67096658'}], 'overallOfficials': [{'name': 'Ruquan Han, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ruquan Han', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}