Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 11:15 PM
Study NCT ID:
NCT01361594
Status:
COMPLETED
Last Update Posted:
2014-12-31
First Post:
2011-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'geumpie@emory.edu', 'phone': '404-778-1665', 'title': 'Dr. Guillermo Umpierrez', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': '3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Intensive Insulin Treatment', 'description': 'Intensive insulin treatment (BG target: 100-140 mg/dL)\n\nRegular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL', 'otherNumAtRisk': 151, 'otherNumAffected': 56, 'seriousNumAtRisk': 151, 'seriousNumAffected': 63}, {'id': 'EG001', 'title': 'Conventional Insulin Treatment', 'description': 'Conventional insulin treatment (BG target: 141-180 mg/dl)\n\nRegular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl', 'otherNumAtRisk': 151, 'otherNumAffected': 50, 'seriousNumAtRisk': 151, 'seriousNumAffected': 78}], 'otherEvents': [{'term': 'Surgical re-intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders'}, {'term': 'ICU Re-admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Hypoglycemia (ICU)', 'notes': 'blood glucose less than 70 mg/dL but greater than 40 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Endocrine disorders'}, {'term': 'Hypoglycemia (immediately after treatment)', 'notes': 'blood glucose less than 70 mg/dL but greater than 40 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Endocrine disorders'}], 'seriousEvents': [{'term': 'Acute renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 28, 'numAffected': 28}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Respiratory Failure', 'notes': 'Intubation \\> 2 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Major Adverse Cardiac Events (MACE)', 'notes': 'defined as death, myocardial infarction, or clinically-driven target lesion revascularizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 51, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 63, 'numAffected': 63}], 'organSystem': 'Cardiac disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects That Were Diagnosed for Peri-operative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Insulin Treatment', 'description': 'Intensive insulin treatment (BG target: 100-140 mg/dL)\n\nRegular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL'}, {'id': 'OG001', 'title': 'Conventional Insulin Treatment', 'description': 'Conventional insulin treatment (BG target: 141-180 mg/dl)\n\nRegular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 6 months of hospitalization', 'description': 'Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glycemic Control', 'timeFrame': 'average 1 month during the hospitalization', 'description': '1. Hyperglycemic events (BG \\> 200 mg/dL) in ICU and non-ICU\n2. Hypoglycemic events (BG \\< 70 mg/dl; severe hypoglycemia (BG \\< 40 mg/dl).', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Major Cardiovascular Events', 'timeFrame': 'average 1 month during the hospitalization', 'description': '1. Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).\n2. Congestive heart failure\n3. Cardiac arrhythmias: malignant arrhythmia', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Acute Renal Failure', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'new-onset abnormal renal function: serum creatinine \\> 2.0 mg/dL or an increment level \\> 50% from baseline', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg.', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'Respiratory failure, defined as PaO2 value \\< 60 mm Hg while breathing air or a PaCO2 \\> 50 mm Hg.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'ICU and Hospital Length of Stay, and ICU Readmissions', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'ICU and hospital length of stay, and ICU readmissions', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Surgical Wound Infection', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'superficial and deep sternal wound infection', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Pneumonia (CDC Criteria)', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'Pneumonia (CDC criteria)', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Cerebrovascular Events', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'permanent stroke and reversible ischemic neurologic deficit.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Insulin Treatment', 'description': 'Intensive insulin treatment (BG target: 100-140 mg/dL)\n\nRegular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL'}, {'id': 'OG001', 'title': 'Conventional Insulin Treatment', 'description': 'Conventional insulin treatment (BG target: 141-180 mg/dl)\n\nRegular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Ventilatory Support and ICU Readmission', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'Duration of ventilatory support and ICU readmission', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Thirty Day Mortality', 'timeFrame': 'within 30 days of discharge', 'description': 'Thirty day mortality', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Hospital Readmissions and Emergency Room Visits', 'timeFrame': 'Within 30 days after discharge', 'description': 'Number of hospital readmissions and emergency room visits', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Organ Failures Assessed by the Daily SOFA Score', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'Incidence of organ failures assessed by the daily SOFA score', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Measures of Inflammation', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Major Cardiovascular Events', 'timeFrame': 'within 3 months after discharge', 'description': '1. Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).\n2. Congestive heart failure\n3. Cardiac arrhythmias: malignant arrhythmia', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Surgical Wound Infection', 'timeFrame': 'within 3 months after discharge', 'description': 'Superficial and deep sternal wound infection', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Pneumonia (CDC Criteria)', 'timeFrame': 'Within 3 months after discharge', 'description': 'Pneumonia (CDC criteria)', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Cerebrovascular Events', 'timeFrame': 'within 3 months after discharge', 'description': 'permanent stroke and reversible ischemic neurologic deficit', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intensive Insulin Treatment', 'description': 'Intensive insulin treatment (BG target: 100-140 mg/dL)\n\nRegular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL'}, {'id': 'FG001', 'title': 'Conventional Insulin Treatment', 'description': 'Conventional insulin treatment (BG target: 141-180 mg/dl)\n\nRegular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Emory University Hospital, Emory University Hospital - Midtown and Grady Hospital', 'preAssignmentDetails': 'Patients undergoing coronary artery bypass surgery (CABG) that develop hyperglycemia (defined as a blood glucose \\>140) intraoperatively or in an intenstive care unit (ICU) post-surgical procedure. 33 patients withdrawn prior to randomization, due to various reasons, including surgery cancellation, transportation to a different hospital, etc.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intensive Insulin Treatment', 'description': 'Intensive insulin treatment (BG target: 100-140 mg/dL)\n\nRegular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL'}, {'id': 'BG001', 'title': 'Conventional Insulin Treatment', 'description': 'Conventional insulin treatment (BG target: 141-180 mg/dl)\n\nRegular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Only subjects that completed the study were accounted for in the baseline characteristics.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 338}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-18', 'studyFirstSubmitDate': '2011-02-03', 'resultsFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2011-05-26', 'lastUpdatePostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-18', 'studyFirstPostDateStruct': {'date': '2011-05-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects That Were Diagnosed for Peri-operative Complications', 'timeFrame': 'Within 6 months of hospitalization', 'description': 'Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization'}, {'measure': 'Hospital Mortality', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission.'}], 'secondaryOutcomes': [{'measure': 'Glycemic Control', 'timeFrame': 'average 1 month during the hospitalization', 'description': '1. Hyperglycemic events (BG \\> 200 mg/dL) in ICU and non-ICU\n2. Hypoglycemic events (BG \\< 70 mg/dl; severe hypoglycemia (BG \\< 40 mg/dl).'}, {'measure': 'Major Cardiovascular Events', 'timeFrame': 'average 1 month during the hospitalization', 'description': '1. Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).\n2. Congestive heart failure\n3. Cardiac arrhythmias: malignant arrhythmia'}, {'measure': 'Acute Renal Failure', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'new-onset abnormal renal function: serum creatinine \\> 2.0 mg/dL or an increment level \\> 50% from baseline'}, {'measure': 'Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg.', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'Respiratory failure, defined as PaO2 value \\< 60 mm Hg while breathing air or a PaCO2 \\> 50 mm Hg.'}, {'measure': 'ICU and Hospital Length of Stay, and ICU Readmissions', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'ICU and hospital length of stay, and ICU readmissions'}, {'measure': 'Surgical Wound Infection', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'superficial and deep sternal wound infection'}, {'measure': 'Pneumonia (CDC Criteria)', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'Pneumonia (CDC criteria)'}, {'measure': 'Cerebrovascular Events', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'permanent stroke and reversible ischemic neurologic deficit.'}, {'measure': 'Duration of Ventilatory Support and ICU Readmission', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'Duration of ventilatory support and ICU readmission'}, {'measure': 'Thirty Day Mortality', 'timeFrame': 'within 30 days of discharge', 'description': 'Thirty day mortality'}, {'measure': 'Number of Hospital Readmissions and Emergency Room Visits', 'timeFrame': 'Within 30 days after discharge', 'description': 'Number of hospital readmissions and emergency room visits'}, {'measure': 'Incidence of Organ Failures Assessed by the Daily SOFA Score', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'Incidence of organ failures assessed by the daily SOFA score'}, {'measure': 'Measures of Inflammation', 'timeFrame': 'average 1 month during the hospitalization', 'description': 'Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers'}, {'measure': 'Major Cardiovascular Events', 'timeFrame': 'within 3 months after discharge', 'description': '1. Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).\n2. Congestive heart failure\n3. Cardiac arrhythmias: malignant arrhythmia'}, {'measure': 'Surgical Wound Infection', 'timeFrame': 'within 3 months after discharge', 'description': 'Superficial and deep sternal wound infection'}, {'measure': 'Pneumonia (CDC Criteria)', 'timeFrame': 'Within 3 months after discharge', 'description': 'Pneumonia (CDC criteria)'}, {'measure': 'Cerebrovascular Events', 'timeFrame': 'within 3 months after discharge', 'description': 'permanent stroke and reversible ischemic neurologic deficit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Coronary Artery Bypass Surgery', 'Glycemic control', 'Insulin infusion'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'High blood glucose levels (hyperglycemia) in cardiac surgery patients with diabetes are associated with increased risk of hospital complications. Blood sugar control with intravenous insulin may prevent such hospital complications. Many patients undergoing cardiac bypass surgery (CABG) develop high blood sugars and require insulin therapy (shortly before or after surgery). It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. Accordingly, this research study aims to determine optimal blood glucose levels during the in patients undergoing cardiac bypass surgery. Patients will be divided in two groups. The intensive insulin group will be maintained at blood glucose between 100-140 mg/dl and the conventional treatment group at a glucose level between 140-180 mg/dl. The insulins to be used in this trial (lantus, aspart and regular insulin) are approved for use in the treatment of patients with diabetes by the FDA (Food and Drug Administration). A total of 326 patients with high blood glucose after cardiac bypass surgery will be recruited in this study. Patients will be recruited at Emory University Hospital, Emory Midtown Hospital and Grady Memorial Hospital.', 'detailedDescription': 'Several prospective cohort studies as well as randomized clinical trials (RCT) in cardiac surgery patients have shown that intensified insulin therapy (target BG: 110-140 mg/dl) results in a reduction in short- and long-term mortality compared with conventionally treated patients. The results of recent international trials in critically ill patients; however, have failed to show a significant improvement in mortality or have even shown increased mortality risk as well as increased number of hypoglycemic events with intensive compared to less intensive glycemic control. Based on the results of these ICU trials, new ADA and AACE guidelines recommended a glycemic target between 140 and 180 mg/dl in the ICU including cardiac surgery patients. There is concern that such high BG targets might increase the risk of hospital complications in cardiac surgical patients in whom intensive glucose control has consistently reduced infections, length of hospital stay, resource utilization, and cardiac-related mortality. The overall objective of this proposal is to conduct the first prospective RCT to determine the optimal BG target during the perioperative period in hyperglycemic subjects who undergo CABG in the United States. Subjects will be randomized to undergo intensive insulin therapy adjusted to maintain a BG between 100 mg/dl and 140 mg/dl or to a conventional glucose control with a target BG between 141 mg/dl and 200 mg/dl in the ICU. The central hypothesis of this proposal is that intensive insulin management will reduce perioperative complications compared to a conventional BG control in cardiac surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females between the ages of 18 and 80 years undergoing CABG +/- valve surgery.\n2. Post surgical hyperglycemia (BG \\> 140 mg/dl).\n3. Patients with and without a history of type 2 diabetes\n\nExclusion Criteria:\n\n1. Patients requiring combination CABG with additional procedures such aorta replacement.\n2. Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or GFR \\< 30 ml/min) or clinically significant hepatic failure.\n3. Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.\n4. Moribund patients and those at imminent risk of death (brain death or cardiac standstill).\n5. Patients or next-to-kin with mental condition rendering the subject or family member unable to understand the nature, scope, and possible consequences of the study.\n6. Female subjects who are pregnant or breast-feeding at time of enrollment into the study.'}, 'identificationModule': {'nctId': 'NCT01361594', 'acronym': 'CABG', 'briefTitle': 'Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery', 'orgStudyIdInfo': {'id': 'IRB00048356'}, 'secondaryIdInfos': [{'id': '00048356-2010', 'type': 'OTHER', 'domain': 'Other'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intensive insulin treatment', 'description': 'Intensive insulin treatment (BG target: 100-140 mg/dL)', 'interventionNames': ['Other: Regular insulin (intensive treatment)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional insulin treatment', 'description': 'Conventional insulin treatment (BG target: 141-180 mg/dl)', 'interventionNames': ['Other: Regular Insulin (conventional treatment)']}], 'interventions': [{'name': 'Regular insulin (intensive treatment)', 'type': 'OTHER', 'description': 'Titration of the IV insulin rate for glucose goal 100-140 mg/dL', 'armGroupLabels': ['Intensive insulin treatment']}, {'name': 'Regular Insulin (conventional treatment)', 'type': 'OTHER', 'description': 'Titration of the IV insulin rate for glucose goal 141-180 mg/dl', 'armGroupLabels': ['Conventional insulin treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30326', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Guillermo E Umpierrez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Guillermo Umpierrez', 'investigatorAffiliation': 'Emory University'}}}}