Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-27 @ 7:59 AM
Study NCT ID:
NCT05464966
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2022-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Primary Objective of This Study Was to Investigate the Effect of Insulin on Myocardial Perfusion and Cardiac Function in Patients Undergoing Cardiac Surgery for CPB Using Transesophageal Echocardiography (TEE) to Detect CSBF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030396', 'term': 'glucose-insulin-potassium cardioplegic solution'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-18', 'studyFirstSubmitDate': '2022-05-15', 'studyFirstSubmitQcDate': '2022-07-17', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the coronary sinus blood flow spectrum', 'timeFrame': 'from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery', 'description': 'coronary sinus blood flow spectrum changes such as SVTI、DVTI、AVTI are assessed by TEE'}, {'measure': 'Changes in left ventricular diastolic function', 'timeFrame': 'from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery', 'description': 'Changes in left ventricular diastolic function are assessed by TEE, such as changes in pulmonary venous blood flow'}], 'secondaryOutcomes': [{'measure': 'Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)', 'timeFrame': 'into ICU 30 minutes', 'description': 'The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery'}, {'measure': 'Changes in the level of Cardiac output', 'timeFrame': 'into ICU 30 minutes', 'description': 'The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery'}, {'measure': 'Changes in the level of Heart Rate', 'timeFrame': 'into ICU 30 minutes', 'description': 'The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery'}, {'measure': 'Changes in the level of SVR', 'timeFrame': 'into ICU 30 minutes', 'description': 'The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery'}, {'measure': 'Changes in the level of SVRI', 'timeFrame': 'into ICU 30 minutes', 'description': 'The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery'}, {'measure': 'Changes in the level of Cardiac index', 'timeFrame': 'into ICU 30 minutes', 'description': 'The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insulin', 'Perioperative period', 'Blood glucose', 'Heart protection'], 'conditions': ['Insulin']}, 'descriptionModule': {'briefSummary': 'The primary objective of this clinical trial was to investigate the effects of insulin on myocardial blood flow reflected by CSBF which was evaluated by TEE. The second aim was to observe the effect of insulin on cardiac function and markers of myocardial damage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria included\n\n1. age 55-80 years, ASA grade II-III, regardless of gender,\n2. BMI 18.5-28.0 kg/m2,\n3. scheduled for elective coronary artery bypass grafting (CABG), valve repair or replacement, or a combination of these procedures with cardiopulmonary bypass.\n\nExclusion criteria\n\n1. non-first cardiac surgery;\n2. emergency cardiac surgery;\n3. severe heart failure with preoperative left ventricular ejection fraction \\<30%;\n4. contraindication to TEE;\n5. kidney disease requiring replacement therapy;\n6. combined with multi-organ insufficiency;\n7. Severe infection requiring continuous antibiotic treatment;\n8. use of large doses of hormone or nonsteroidal anti-inflammatory drugs within the last 2 weeks.\n9. after the patient entered the operating room, if the first blood glucose exceeded 180 mg/dl, a second test was performed 15 minutes later, and if the average of the two blood glucoses exceeded 180 mg/dl, the patient was excluded as well.\n\nElimination criteria included\n\n1. unplanned secondary CPB;\n2. need for intra-aortic balloon pump technical support during the study period;\n3. TEE image acquired with poor quality.'}, 'identificationModule': {'nctId': 'NCT05464966', 'briefTitle': 'The Primary Objective of This Study Was to Investigate the Effect of Insulin on Myocardial Perfusion and Cardiac Function in Patients Undergoing Cardiac Surgery for CPB Using Transesophageal Echocardiography (TEE) to Detect CSBF', 'organization': {'class': 'OTHER', 'fullName': 'Yangzhou University'}, 'officialTitle': 'The Primary Objective of This Study Was to Investigate the Effect of Insulin on Myocardial Perfusion in Patients Undergoing Cardiac Surgery for CPB Using Transesophageal Echocardiography (TEE) to Detect CSBF and the Secondary Objective Was to Observe the Effect of Insulin on Cardiac Function and Markers of Myocardial Injury', 'orgStudyIdInfo': {'id': '20220515'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glucose-insulin-potassium', 'interventionNames': ['Drug: Glucose insulin potassium']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Glucose insulin potassium', 'type': 'DRUG', 'description': 'After induction of anaesthesia,cardiac systolic-diastolic function was first measured by TEE, GIK solution was continuously pumped until the end of the procedure at a dose of 30 mU/kg/h of insulin, 0.12 g/kg/h of glucose and 0.06 mmol/kg/h of potassium chloride', 'armGroupLabels': ['Glucose-insulin-potassium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yangzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'the Affiliated Hospital of Yangzhou University, Yangzhou University', 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yangzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhuan Zhang', 'investigatorAffiliation': 'Yangzhou University'}}}}