Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT03973320
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'liuji@hss.edu', 'phone': '2126061036', 'title': 'Dr. Jiabin Liu', 'organization': 'Hospital for Special Surgery, Anesthesiology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The time period to which adverse events (i.e. deaths) were collected was up to 30 days following a total hip arthroplasty surgery.', 'description': 'The primary outcome was "the incidences of (i) myocardial infarction (MI), (ii) cerebrovascular accident (CVA), (iii) death, and (iv) calculated perioperative intraoperative blood loss", and these events were recorded retrospectively. As a result, none of the three types of adverse events posed a risk to participants. This study collects past information and no new data was actively collected from individuals.', 'eventGroups': [{'id': 'EG000', 'title': 'Primary Total Hip Arthroplasty', 'description': 'This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty\n\nChart Review: This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.', 'otherNumAtRisk': 11292, 'deathsNumAtRisk': 11292, 'otherNumAffected': 18, 'seriousNumAtRisk': 11292, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11292, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11292, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Total Hip Arthroplasty', 'description': 'This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty\n\nChart Review: This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.'}], 'classes': [{'categories': [{'title': 'Myocardial Infarction', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Stroke', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'In-Hospital mortality', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '30-day mortality', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of Surgery (Day 0) through discharge (days til discharge is an average of 2 days), follow-ups up to 30 days post-surgery', 'description': 'The association between levels and length of intraoperative controlled hypotension and incidence rates of individual and composite outcome of any of the following events: (i) myocardial infarction (MI), (ii) cerebrovascular accident (CVA), (iii) death. If any of these events are positive, then the composite outcome will be positive. The units of measurement will be the same.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '21 patients out of 11,292 fit complication definition.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Primary Total Hip Arthroplasty', 'description': 'This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty\n\nChart Review: This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11292'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11292'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11224', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '11292', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Primary Total Hip Arthroplasty Without Complications', 'description': 'This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty\n\nChart Review: This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.'}, {'id': 'BG001', 'title': 'Primary Total Hip Arthroplasty With Common Complications', 'description': 'This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty\n\nChart Review: This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '57', 'upperLimit': '71.5'}, {'value': '75.6', 'groupId': 'BG001', 'lowerLimit': '63.1', 'upperLimit': '81.6'}, {'value': '64', 'groupId': 'BG002', 'lowerLimit': '57', 'upperLimit': '71.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5955', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '5985', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5269', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '5307', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race: White', 'categories': [{'measurements': [{'value': '9842', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '9891', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI (Body Mass Index)', 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'groupId': 'BG000', 'lowerLimit': '24.8', 'upperLimit': '32.1'}, {'value': '28', 'groupId': 'BG001', 'lowerLimit': '25.1', 'upperLimit': '33.3'}, {'value': '28.1', 'groupId': 'BG002', 'lowerLimit': '24.8', 'upperLimit': '32.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Anesthetic type: Spinal', 'classes': [{'categories': [{'measurements': [{'value': '3584', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '3600', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Anesthetic type: Epidural/CSE', 'classes': [{'categories': [{'measurements': [{'value': '7640', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '7692', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ASA of 1 & 2', 'classes': [{'categories': [{'measurements': [{'value': '9254', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '9291', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The purpose of the system is to assess and communicate a patient's pre-anesthesia medical co-morbidities.\n\nASA I A normal healthy patient. ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life.\n\nPatients are given an ASA prior to surgery and this is listed on their EPIC chart.", 'unitOfMeasure': 'Participants'}, {'title': 'ASA of 3', 'classes': [{'categories': [{'measurements': [{'value': '1970', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '2001', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-05', 'size': 163299, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-20T11:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11292}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2019-05-28', 'resultsFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2019-05-31', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-28', 'studyFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality', 'timeFrame': 'Day of Surgery (Day 0) through discharge (days til discharge is an average of 2 days), follow-ups up to 30 days post-surgery', 'description': 'The association between levels and length of intraoperative controlled hypotension and incidence rates of individual and composite outcome of any of the following events: (i) myocardial infarction (MI), (ii) cerebrovascular accident (CVA), (iii) death. If any of these events are positive, then the composite outcome will be positive. The units of measurement will be the same.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Hip Arthroplasty', 'Primary Total Hip Arthroplasty', 'Hypotension', 'Database']}, 'descriptionModule': {'briefSummary': 'This is a retrospective chart review to determine if neuraxial anesthesia is associated with worse outcomes after Primary Total Hip Arthroplasty.', 'detailedDescription': 'The goal of this study is to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty. The plan to analyze the outcomes is listed below:\n\nPrimary outcomes:\n\nMultiple logistic regression will be used to compute the adjusted odds ratios of any postoperative complications (MI, CVA, death) , adjusting for covariates including duration of intraoperative mean arterial pressure of less than pre-defined threshold, such as 55, or 60 mmHg mean blood pressure.\n\nSensitivity analyses will also consider the effects of intra-operative hypotension (IOH) defined as mean blood pressure of less than 40, 45, 50, 55, 60, and 65 mm Hg.\n\nSecondary outcomes:\n\nMultiple logistic regression will be to compute the adjusted odds ratios of individual postoperative complications, (such as MI, CVA, stroke) , adjusting for covariates including duration of intraoperative mean blood pressure of less than pre-defined threshold, such as 55, or 60 mmHg mean blood pressure. Sensitivity analyses will also be conducted to test the effects of extend of IOH on complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing Primary Total Hip Arthroplasty', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All primary total hip arthroplasty patient data with sufficiently complete intraoperative vital signs\n\nExclusion Criteria:\n\n* Revision primary total hip arthroplasty\n* Incomplete intraoperative vital signs\n* Anterior total hip arthroplasty'}, 'identificationModule': {'nctId': 'NCT03973320', 'briefTitle': 'Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': '2018-2235'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Total Hip Arthroplasty', 'description': 'This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty', 'interventionNames': ['Other: Chart Review']}], 'interventions': [{'name': 'Chart Review', 'type': 'OTHER', 'description': 'This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.', 'armGroupLabels': ['Primary Total Hip Arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jiabin Liu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}