Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT03103633
Status:
COMPLETED
Last Update Posted:
2019-03-25
First Post:
2017-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Individualized Oxygen Dynamic on Prognosis of Patients With High-risk Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D047568', 'term': 'Unsafe Sex'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056805', 'term': 'Consciousness Monitors'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Patients were followed up by an investigator unaware of the patients' achievement or not of the oxygen dynamic goal"}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional group:MAP declined with less than 20% of baseline, BIS 45-60 before and after CPB; and BIS 40-45 during CPB, Brain oxygen saturation declined with less than 20% of baseline.\n\nControl group：no intervention beside the same monitoring with MAP, BIS and brain oxygen saturation and receiving standard measures to achieve a heart rate (HR) in the range of 60-100 beats/min, central venous oxygen saturation (Svco2) higher than 70%, lactate level lower than 3 mmol/L, hematocrit value higher than 28%, and urinary output higher than 0.5 mL/kg/hr.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-21', 'studyFirstSubmitDate': '2017-04-01', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major postoperative complications(i.e., Rate of low cardiac output syndrome, stroke, myocardial ischemia, infection,reoperation, and need for dialysis)', 'timeFrame': '30-day after surgery', 'description': 'Number of Participants with major complications extracted after 30-day follow-up'}, {'measure': '30-day mortality', 'timeFrame': '30-day after surgery', 'description': 'Data for duration of postoperative 30-day all-cause mortality'}, {'measure': 'The change of incidence of postoperative delirium', 'timeFrame': 'The 1,2,3 day after surgery', 'description': 'Through Confusion Assessment Method (CAM)to assess the incidence of the postoperative delirium'}, {'measure': '1,3,5-year mortality', 'timeFrame': '1,3,5-year after surgery', 'description': 'Data for duration of 1,3,5-year all-cause mortality is extracted after 1-year follow-up'}], 'secondaryOutcomes': [{'measure': 'postoperative hospital stay', 'timeFrame': '30-day after surgery', 'description': 'Data for duration of postoperative hospital stay is extracted after 30-day follow-up'}, {'measure': 'The change of incidence of postoperative cognition dysfunction', 'timeFrame': '1 day before surgery, the 3,7 day after the surgery', 'description': 'The neuropsychological tests performed at the day before the surgery,the 3,7 day after the surgery respectively.'}, {'measure': 'The occurrence of cardiovascular events', 'timeFrame': '30-day after surgery', 'description': 'Data for duration of the occurrence of cardiovascular events is extracted 30-day follow-up'}, {'measure': 'The incidence of any adverse events', 'timeFrame': '30-day after surgery', 'description': 'Including kidney or brain related adverse events 30-day after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oxygen dynamics', 'Prognosis'], 'conditions': ['Cardiac Disease', 'High Risk Sex']}, 'referencesModule': {'references': [{'pmid': '32889413', 'type': 'DERIVED', 'citation': 'Cheng XQ, Zhang JY, Wu H, Zuo YM, Tang LL, Zhao Q, Gu EW. Outcomes of individualized goal-directed therapy based on cerebral oxygen balance in high-risk patients undergoing cardiac surgery: A randomized controlled trial. J Clin Anesth. 2020 Dec;67:110032. doi: 10.1016/j.jclinane.2020.110032. Epub 2020 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'Anesthesia-related factors have been linked to poor perioperative outcomes. Our observational study suggested that the cumulative duration of a triple-low state \\[intraoperative low mean arterial pressure (MAP), low bispectral index (BIS), and low target effect-site concentration(Ce) \\]was associated with poorer 30-day mortality.This randomized, prospective study based on individualized Oxygen dynamics is designed to confirm this association in high-risk patients cardiopulmonary bypass (CPB).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent;\n2. Selective cardiac surgery and general anesthesia patients;\n3. Age 18-90 yrs;\n4. Anesthesia Society of American (ASA) Scale II-IV\n5. European System for Cardiac Operative Risk Evaluation score equal to or greater than 6 or left ventricular ejection fraction lower than 50%\n\nExclusion Criteria:\n\n1. Preoperative cardiac ejection fraction\\<30 %;\n2. History of anesthesia awareness;\n3. History or anticipation of difficult intubation;\n4. Unanticipated intraoperative conditions, including haemorrhage, obstinate resuscitation failure,multiple cardiopulmonary bypass procedures, severe hypotension or hypoxemia;\n5. long-term preoperative use of anticonvulsant agents, opiates, benzodiazepines or cocaine.'}, 'identificationModule': {'nctId': 'NCT03103633', 'briefTitle': 'The Effects of Individualized Oxygen Dynamic on Prognosis of Patients With High-risk Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Anhui Medical University'}, 'officialTitle': 'Effects of Perioperative Goal-Directed Therapy Based on Individualized Oxygen Balance on Outcomes During High-risk Cardiac Surgery:A Single Center, Prospective,Randomized,Controlled,Double Blinded Study.', 'orgStudyIdInfo': {'id': 'FirstAnhuiM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individualized Goal-Directed Therapy', 'description': 'The goal of intervention:mean artery pressure declined with less than 20% of baseline, BIS 45-60 before and after CPB; and BIS 40-45 during CPB, Brain oxygen saturation declined with less than 20% of baseline.', 'interventionNames': ['Procedure: mean artery pressure', 'Procedure: bispectral index', 'Procedure: Brain oxygen saturation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Controlled', 'description': 'no intervention beside the same monitoring with MAP, BIS and brain oxygen saturation and receiving standard measures to achieve a heart rate (HR) in the range of 60-100 beats/min, central venous oxygen saturation (Svco2) higher than 70%, lactate level lower than 3 mmol/L, hematocrit value higher than 28%, and urinary output higher than 0.5 mL/kg/hr.', 'interventionNames': ['Other: Controlled']}], 'interventions': [{'name': 'mean artery pressure', 'type': 'PROCEDURE', 'description': 'mean artery pressure declined with less than 20% of baseline', 'armGroupLabels': ['Individualized Goal-Directed Therapy']}, {'name': 'bispectral index', 'type': 'PROCEDURE', 'otherNames': ['BIS'], 'description': 'BIS 45-60 before and after CPB; and BIS 40-45 during CPB', 'armGroupLabels': ['Individualized Goal-Directed Therapy']}, {'name': 'Brain oxygen saturation', 'type': 'PROCEDURE', 'description': 'Brain oxygen saturation declined with less than 20% of baseline', 'armGroupLabels': ['Individualized Goal-Directed Therapy']}, {'name': 'Controlled', 'type': 'OTHER', 'description': 'receiving standard measures to achieve a heart rate (HR) in the range of 60-100 beats/min, central venous oxygen saturation (Svco2) higher than 70%, lactate level lower than 3 mmol/L, hematocrit value higher than 28%, and urinary output higher than 0.5 mL/kg/hr.', 'armGroupLabels': ['Controlled']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230022', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}