Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-05 @ 5:30 PM
Study NCT ID:
NCT04117867
Status:
UNKNOWN
Last Update Posted:
2020-12-04
First Post:
2019-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between Intraoperative Hypotension and Perioperative Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-03', 'studyFirstSubmitDate': '2019-09-27', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of perioperative stroke', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs'}, {'measure': 'Incidence of perioperative stroke', 'timeFrame': 'Within 3 days after surgery', 'description': 'Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs'}, {'measure': 'Incidence of perioperative stroke', 'timeFrame': 'Within 7 days after surgery', 'description': 'Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs'}, {'measure': 'Incidence of perioperative stroke', 'timeFrame': 'Within 30 days after surgery', 'description': 'Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs'}], 'secondaryOutcomes': [{'measure': 'Rate of death', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Death from any cause'}, {'measure': 'Rate of death', 'timeFrame': 'Within 3 days after surgery', 'description': 'Death from any cause'}, {'measure': 'Rate of death', 'timeFrame': 'Within 7 days after surgery', 'description': 'Death from any cause'}, {'measure': 'Rate of death', 'timeFrame': 'Within 30 days after surgery', 'description': 'Death from any cause'}, {'measure': 'Expense of Healthe care and social service', 'timeFrame': 'Through study completion, an average of 14 days', 'description': 'The expense of Healthe care and social service that the patients spent in hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perioperative Complication', 'Intraoperative Hypotension']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the association between the severity and duration of intraoperative hypotension and the incidence of perioperative stroke after non-cardiac and non-neurologic surgeries.The secondary aim of this study is to confirm the potential risk factors of the perioperative stroke.', 'detailedDescription': 'Optimized intraoperative management may play an important role in perioperative stroke prevention. Maintaining blood pressure near preoperative baseline values may help decrease the incidence of stroke, however the related evidence is limited.Therefore, this study is to investigate the association between intraoperative hemodynamic variable and the risk of perioperative stroke after non-cardiac and non-neurologic surgeries. The secondary aim of this study is to establish the potential risk factors of the perioperative stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who underwent surgical procedures under anesthesia at Qianfoshan Hospital, First Hospital affiliated to Shandong First Medical University during the period from January, 2013, to October, 2019, will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients underwent surgeries in First hospital affiliated to Shandong First Medical University from January 2013 to October 2019\n2. Age\\>18 or older\n\nExclusion Criteria:\n\n1. Patients received local infiltration anesthesia\n2. Patients underwent total intravenous anesthsia without tracheal intubation or Laryngeal Mask Airway insertion\n3. Major vascular operation\n4. Neurologic surgery\n5. Cariac surgery\n6. Intraoperative blood pressure measurements or postoperative neuroimagings measurements are not available\n7. History of severe neurological or psychiatric disease'}, 'identificationModule': {'nctId': 'NCT04117867', 'briefTitle': 'The Association Between Intraoperative Hypotension and Perioperative Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'The Association Between Intraoperative Hypotension and Perioperative Stroke in General Surgery Patients: a Retrospective, Hospital-based Study in China', 'orgStudyIdInfo': {'id': 'IOHPS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intraoperative hypotension', 'interventionNames': ['Behavioral: Patiens with intraoperative hypotension']}], 'interventions': [{'name': 'Patiens with intraoperative hypotension', 'type': 'BEHAVIORAL', 'description': 'In this study, we will use four previously defined thresholds for intraoperative hypotension: two absolute thresholds (MAP less than 50 mmHg and MAP less than 60 mmHg) and two relative thresholds to the baseline MAP (a decrease of 30% or more and a decrease of 40% or more). A definition of baseline value most frequently reported was the arterial blood pressure before the induction of anesthesia. Therefore, the baseline MAP used in calculating the relative thresholds is defined as the mean MAP of all available blood pressure measurements before induction of anesthesia in the operating room.', 'armGroupLabels': ['Intraoperative hypotension']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lili Cao, PH.D', 'role': 'CONTACT'}, {'name': 'Yuelan Wang, PH.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First affiliated hospital of Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yuelan Wang, Doctor', 'role': 'CONTACT', 'email': 'qylvmeng@163.com', 'phone': '+86053189268535'}], 'overallOfficials': [{'name': 'Yuelan Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lili Cao', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}