Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT05555693
Status:
RECRUITING
Last Update Posted:
2022-09-27
First Post:
2022-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Postoperative Cognitive-related Adverse Reactions and Brain Metabolomic Characteristics in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MMSE (mini-mental state examiniation)', 'timeFrame': '1 day after surgery', 'description': 'MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.'}, {'measure': 'MMSE (mini-mental state examiniation)', 'timeFrame': 'immediately before surgery', 'description': 'MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.'}, {'measure': 'MMSE (mini-mental state examiniation)', 'timeFrame': '3 day after surgery', 'description': 'MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.'}, {'measure': 'MMSE (mini-mental state examiniation)', 'timeFrame': '7 day after surgery', 'description': 'MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.'}, {'measure': 'MOCA (Montreal Cognitive Assessment)', 'timeFrame': '1 day after surgery', 'description': 'MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.'}, {'measure': 'MOCA (Montreal Cognitive Assessment)', 'timeFrame': '3 day after surgery', 'description': 'MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.'}, {'measure': 'MOCA (Montreal Cognitive Assessment)', 'timeFrame': '7 day after surgery', 'description': 'MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.'}, {'measure': 'MOCA (Montreal Cognitive Assessment)', 'timeFrame': 'immediately before surgery', 'description': 'MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.'}], 'secondaryOutcomes': [{'measure': '3D-CAM', 'timeFrame': '1 day after surgery', 'description': '3D-CAM score'}, {'measure': 'Self-Rating Anxiety Scale', 'timeFrame': 'immediately before surgery', 'description': 'Self-Rating Anxiety Scale score'}, {'measure': 'Self-rating depression scale', 'timeFrame': 'immediately before surgery', 'description': 'Self-rating depression scale score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['POCD - Postoperative Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': "Postoperative cognitive dysfunction (POCD) refers to the difficulties of orientation, cognition, communication, memory and abstract thinking of patients after anesthesia and surgery. And/or accompanied by the decline of the ability in social activities, such as the change of personality, social ability of language and behavior, cognitive function and life skills. POCD is a common complication of central nervous system in elderly patients after operation, with an early incidence of about 21% and a long-term incidence of about 35% . According to the current research on Alzheimer's disease (AD) and POCD in the elderly, it has been found that they have similar pathological basis and some homologous related genes. Altogether, POCD is closely related to molecular pathway neuropsychiatric diseases (such as dementia, depression and Alzheimer's disease). Researchers have come up with various hypotheses to reveal the underlying mechanisms of POCD, including neuritis, oxidative stress, autophagy disorder, synaptic dysfunction, and lack of neurotrophic support. To date, apart from evaluating with scales, CT Scan and EEG analysis, there is neither exact biomarkers for monitoring and diagnosing POCD, nor clear relationships between specific Brain Metabolomic Characteristics, EEG changes and diagnosis of POCD, so that the diagnosis of early POCD only stays in the evaluation of clinical symptoms and scales. Therefore, our study aims to provide an effective basis for early diagnosis and treatment of clinical POCD through multivariate analyses of clinical scales combined with Brain Metabolomic Characteristics, EEG analysis of patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Our research is a single center, nested case-control study. Preoperatively collect the information of the elderly patients over 65 years old without undergoing craniocerebral operations, including the vital signs, the examination reports and other related data after excluding the factors that can't be included in the group. The patients' health scales and preoperative cognitive function scales were evaluated.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 years or older .\n* Complete the operation in our hospital\n* ASA classification I-II level\n* Agree to participate in this research and agree to sign an informed consent form\n\nExclusion Criteria:\n\n* History of preoperative psychosis and psychotropic drug use\n* The subject is diagnosed with AD;\n* Abnormal preoperative mental scale assessment\n* Have a history of emergency rescue during the perioperative period\n* metal implants\n* Postoperative immobilization patients'}, 'identificationModule': {'nctId': 'NCT05555693', 'briefTitle': 'Correlation Between Postoperative Cognitive-related Adverse Reactions and Brain Metabolomic Characteristics in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}, 'officialTitle': 'Correlation Between Postoperative Cognitive-related Adverse Reactions and Brain Metabolomic Characteristics in Elderly Patients', 'orgStudyIdInfo': {'id': 'SH9H-2022-T133-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients in the control group were followed up without POCD postoperatively.', 'description': 'If the MOCA or MMSE assessment all show a negative resluts at all time point.', 'interventionNames': ['Other: Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample']}, {'label': 'Patients in the case group were followed up with POCD postoperatively.', 'description': 'If the MOCA assessment is positive at any time point after surgery, and there is a positive MMSE at any time point after surgery(no need for both MOCA and MMSE to be positive at the same time', 'interventionNames': ['Other: Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample']}], 'interventions': [{'name': 'Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample', 'type': 'OTHER', 'description': 'Collecting clinical data(before induction of anesthesia and first day after surgery), EGG（first day after surgery），Magnetic Resonance Spectroscopy data (before induction of anesthesia and first day after surgery)blood gas data(before induction of anesthesia and first day after surgery) and blood sample （before induction of anesthesia and first day, third day and 7th day after surgery）', 'armGroupLabels': ['Patients in the case group were followed up with POCD postoperatively.', 'Patients in the control group were followed up without POCD postoperatively.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Jiang', 'role': 'CONTACT', 'email': 'jianghongjiuyuan@163.com'}], 'facility': 'Shanghai 9Th Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ren Zhou, PhD', 'role': 'CONTACT', 'email': 'zhouren77@126.com', 'phone': '15121007303'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}