Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-18 @ 5:07 PM
Study NCT ID:
NCT03934892
Status:
COMPLETED
Last Update Posted:
2019-05-02
First Post:
2019-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Value of Peak Lactate During Cardiopulmonary Bypass in Adult Cardiac Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-30', 'studyFirstSubmitDate': '2019-04-24', 'studyFirstSubmitQcDate': '2019-04-30', 'lastUpdatePostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'in-hospital mortality', 'timeFrame': 'From date of inclusion until date of death from any cause during hospitalization, assessed up to one year', 'description': 'peak lactate level during cardiopulmonary bypass predicts in-hospital mortality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiopulmonary Bypass', 'Lactate']}, 'referencesModule': {'references': [{'pmid': '11156124', 'type': 'RESULT', 'citation': 'Demers P, Elkouri S, Martineau R, Couturier A, Cartier R. Outcome with high blood lactate levels during cardiopulmonary bypass in adult cardiac operation. Ann Thorac Surg. 2000 Dec;70(6):2082-6. doi: 10.1016/s0003-4975(00)02160-3.'}, {'pmid': '22813486', 'type': 'RESULT', 'citation': "O'Connor E, Fraser JF. The interpretation of perioperative lactate abnormalities in patients undergoing cardiac surgery. Anaesth Intensive Care. 2012 Jul;40(4):598-603. doi: 10.1177/0310057X1204000404."}]}, 'descriptionModule': {'briefSummary': "Tissue hypoperfusion during cardiopulmonary bypass (CPB) affects cardiac surgical outcomes. Lactate, an end product of anaerobic glycolysis from oxygen deficit, is an obtainable marker of tissue hypoxia. The investigators aimed to determine the value of blood lactate level during CPB in adult cardiac surgeries in predicting outcomes.\n\nThe investigators retrospectively reviewed the patients underwent cardiac surgeries with CPB from January 2015 to December 2015. The patient's characteristics, pre-operative status, surgical type, and intra-operative lactate levels were collected. The outcomes were in-hospital mortality and complications. Receiver operating characteristics (ROC) curves were used to assess the ability of peak lactate level during CPB to predict in-hospital mortality.", 'detailedDescription': 'The baseline characteristics, including age, gender, body mass index (BMI), comorbidities, left ventricular ejection fraction (LVEF, %), European system for cardiac operative risk evaluation II (EuroSCORE II), pre-operative hematocrit, and serum creatinine levels were recorded. The surgical type was classified as coronary artery bypass grafting (CABG), valve surgery, combined surgery including CABG and valve surgery, great vessel surgery including aortic dissection, and other surgeries. The priority of surgery was classified as elective, urgent, and emergent. The intra-operative variables included CPB time, aortic cross-clamp time, initial lactate level at the beginning of the operation, and the peak lactate level during CPB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adults patients underwent cardiac surgeries with cardiopulmonary bypass from January 2015 to December 2015', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults patients underwent cardiac surgeries with cardiopulmonary bypass from January 2015 to December 2015\n\nExclusion Criteria:\n\n* patients with missing data from records'}, 'identificationModule': {'nctId': 'NCT03934892', 'briefTitle': 'Prognostic Value of Peak Lactate During Cardiopulmonary Bypass in Adult Cardiac Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Hualien Tzu Chi General Hospital'}, 'officialTitle': 'Prognostic Value of Peak Lactate During Cardiopulmonary Bypass in Adult Cardiac Surgeries: a Cohort Study', 'orgStudyIdInfo': {'id': 'HualienTCGH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'lactate during CPB', 'description': 'check lactate levels routinely during cardiac operations with cardiopulmonary bypass, choose the peak lactate data', 'interventionNames': ['Diagnostic Test: serum lactate']}], 'interventions': [{'name': 'serum lactate', 'type': 'DIAGNOSTIC_TEST', 'description': 'check lactate levels during cardiopulmonary bypass in adult cardiac operations', 'armGroupLabels': ['lactate during CPB']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yi-tso Cheng, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hualien Tzu Chi General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The individual participant data (IPD) will be available on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hualien Tzu Chi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Yi-Tso Cheng', 'investigatorAffiliation': 'Hualien Tzu Chi General Hospital'}}}}