Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-06 @ 7:04 AM
Study NCT ID:
NCT05211934
Status:
UNKNOWN
Last Update Posted:
2022-01-27
First Post:
2022-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Postoperative Delirium and Heart Function in Valvular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'heart function', 'timeFrame': 'up to 60 days', 'description': 'Doses of norepinephrine, epinephrine, dopamine, dobutamine and vasopressin'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Valvular Surgery']}, 'descriptionModule': {'briefSummary': 'Delirium is an acute brain lesion characterized by abnormalities of consciousness, attention, cognition and sensation. Many brain diseases such as stroke, traumatic brain injury and intracranial hypertension can lead to cardiac insufficiency, arrhythmia and heart failure. The incidence of postoperative delirium in patients undergoing cardiac surgery is high. Postoperative delirium is a manifestation of brain function injury. The effect of postoperative delirium on postoperative cardiac function in patients undergoing cardiac surgery is worthy of further discussion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing valvular surgery in our hospital were selected. The age was 60 years ≤ age ≤75 years, and gender was not limited. According to the occurrence of postoperative delirium, the patients were divided into postoperative delirium group and Non-postoperative delirium group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing valvular surgery\n* Age between 60 to 75\n\nExclusion Criteria:\n\n* Have a history of cerebral infarction before operation\n* Cardiac function was seriously impaired before surgery\n* Neuropsychiatric disorders were present before surgery'}, 'identificationModule': {'nctId': 'NCT05211934', 'briefTitle': 'Relationship Between Postoperative Delirium and Heart Function in Valvular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Relationship Between Postoperative Delirium and Heart Function in Valvular Surgery：A Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': '20220101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The group with delirium', 'interventionNames': ['Other: No intervention']}, {'label': 'The group without delirium', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['The group with delirium', 'The group without delirium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Ma, PhD', 'role': 'CONTACT', 'email': 'majun7689@163.com', 'phone': '13370103571'}], 'facility': 'Anzhen hospital, Beijing', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jun Ma', 'role': 'CONTACT', 'email': 'majun7689@163.com', 'phone': '13370103571'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The chief of department of anesthesiology', 'investigatorFullName': 'Jun Ma', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}