Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT00328094
Status:
TERMINATED
Last Update Posted:
2013-04-17
First Post:
2006-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Glycemic Control to Prevent Cardiac Morbidity in Vascular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bsubrama@bidmc.harvard.edu', 'phone': '6177542675', 'title': 'Dr. Balachundhar Subramaniam, MD MPH', 'organization': 'Beth Israel Deaconess Medical Center, Boston, MA'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'A trial to adequately address mortality would require 5000 to 6000 patients. The alpha levels for significance were not adjusted for the interim analyses because of the unplanned issues with subject recruitement as surgery became percutaneous.'}}, 'adverseEventsModule': {'timeFrame': 'Study period. Hospital stay', 'eventGroups': [{'id': 'EG000', 'title': 'Continuous Insulin Infusion', 'description': 'Tight glucose group with insulin infusion', 'otherNumAtRisk': 114, 'otherNumAffected': 23, 'seriousNumAtRisk': 114, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Intermittent Insulin Bolus', 'description': 'Intermittent insulin boluses group', 'otherNumAtRisk': 122, 'otherNumAffected': 22, 'seriousNumAtRisk': 122, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Creatinine > 25% increase', 'notes': 'INcrease in creatinine \\> 25% in the postoperative period from the preoperative period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'HYPOGLYCEMIA', 'notes': 'Blood glucose \\< 60 mg/dL atleast once', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Incidence of Wound Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Insulin Infusion', 'description': 'Tight glucose group with insulin infusion'}, {'id': 'OG001', 'title': 'Intermittent Insulin Bolus', 'description': 'Intermittent insulin boluses group'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.97', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'postoperative', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Composite (Myocardial Infarction and CHF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Insulin Infusion', 'description': 'Tight glucose group with insulin infusion'}, {'id': 'OG001', 'title': 'Intermittent Insulin Bolus', 'description': 'Intermittent insulin boluses group'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'hospital length of stay', 'unitOfMeasure': 'Number of patients', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Continuous Insulin Infusion', 'description': 'Tight glucose group with insulin infusion'}, {'id': 'FG001', 'title': 'Intermittent Insulin Bolus', 'description': 'Intermittent insulin boluses group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '2 did not receive intervention. 1 patient refusal', 'groupId': 'FG000', 'numSubjects': '114'}, {'comment': '3 did not receive interevention. 1 post induction arrest. 1 case cancelled.', 'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Perioperative period in Beth Israel Deaconess Medical Center, West Campus was the only location for the recruitment.', 'preAssignmentDetails': '252 were assessed for eligibility. 10 did not meet inclusion criterion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Continuous Insulin Infusion', 'description': 'Tight glucose group with insulin infusion'}, {'id': 'BG001', 'title': 'Intermittent Insulin Bolus', 'description': 'Intermittent insulin boluses group'}, {'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': '49', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '10', 'groupId': 'BG000'}, {'value': '71', 'spread': '11', 'groupId': 'BG001'}, {'value': '69', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'assessed for eligibility 252. 10 were found ineligible. 242 were randomized.6 patients did not receive interventions they were supposed to. Total number of patients analyzed were 236.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'whyStopped': 'The recruitment rate slowed considerably', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-10', 'studyFirstSubmitDate': '2006-05-18', 'resultsFirstSubmitDate': '2013-02-28', 'studyFirstSubmitQcDate': '2006-05-18', 'lastUpdatePostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-28', 'studyFirstPostDateStruct': {'date': '2006-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite (Myocardial Infarction and CHF)', 'timeFrame': 'hospital length of stay'}], 'secondaryOutcomes': [{'measure': 'Incidence of Wound Infections', 'timeFrame': 'postoperative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tight', 'Glycemic', 'control', 'outcomes', 'peripheral vascular disease', 'infection', 'cardiovascular', 'morbidity', 'mortality'], 'conditions': ['Peripheral Vascular Disease', 'Abdominal Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '10197653', 'type': 'BACKGROUND', 'citation': 'Furnary AP, Zerr KJ, Grunkemeier GL, Starr A. Continuous intravenous insulin infusion reduces the incidence of deep sternal wound infection in diabetic patients after cardiac surgical procedures. Ann Thorac Surg. 1999 Feb;67(2):352-60; discussion 360-2. doi: 10.1016/s0003-4975(99)00014-4.'}, {'pmid': '11794168', 'type': 'BACKGROUND', 'citation': 'van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.'}, {'pmid': '15150382', 'type': 'BACKGROUND', 'citation': 'Zimmerman CR, Mlynarek ME, Jordan JA, Rajda CA, Horst HM. An insulin infusion protocol in critically ill cardiothoracic surgery patients. Ann Pharmacother. 2004 Jul-Aug;38(7-8):1123-9. doi: 10.1345/aph.1E018. Epub 2004 May 18.'}, {'pmid': '16192757', 'type': 'BACKGROUND', 'citation': 'Kersten JR, Warltier DC, Pagel PS. Aggressive control of intraoperative blood glucose concentration: a shifting paradigm? Anesthesiology. 2005 Oct;103(4):677-8. doi: 10.1097/00000542-200510000-00002. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Aggressive intraoperative and postoperative management of blood glucose may substantially decrease perioperative cardiovascular and infectious complications in diabetic and non-diabetic patients undergoing vascular surgery.\n\nThe purpose of this study is to compare the tight versus traditional blood glucose control in diabetics and non-diabetics undergoing vascular surgery in regard to their postoperative fatal and nonfatal cardiac outcomes, and the secondary effects such as rate of infections, overall morbidity and 30-day mortality.', 'detailedDescription': 'This is a randomized, prospective controlled trial in both diabetic and non diabetic patients undergoing vascular surgery such as abdominal aortic, infra inguinal vascular bypass procedures and amputations, comparing tight versus standard blood glucose control regimens in the operating room, post anesthesia care unit and in the postoperative vascular intensive care unit up to 48 hours and its impact on the cardiovascular, infectious and other morbidity and mortality during the hospital admission and up to 30 days from surgery.\n\nAfter obtaining informed consent, the study subjects will be randomized to tight versus standard blood glucose control regimens. These regimens will be started in the operating room and continued for the first 48 hours or until their discharge, whichever is earlier. All the patients will be inpatients. Day surgery patients will be excluded.\n\nThe anesthesiologist providing patient care will be given either the tight glucose control protocol or the standard sliding scale insulin protocol. In the tight control regimen, target blood glucose is 100-150 mg/dl. If 3 consecutive blood glucose (BG) level \\>150 mg/dL or 1 BG level \\>200 mg/dL, then the insulin infusion will be initiated in the tight control group. The insulin infusion rate adjustments will be made based on the blood sugar results. In post anesthetic care unit (PACU) and vascular intensive care unit (VICU), these protocols will be nurse driven. The adjustments will be made based on the current blood sugar levels as well as the insulin infusion rates. They are adjusted in such a way to account for the rate of change of blood sugars and the presence of steroid therapy in the patients. The frequency of blood glucose testing in this group will be every 1-hour until stable (when frequent changes in insulin dosage are no longer necessary, and glucose is in the range of 100 to 150 for 3 consecutive blood sugar checks); then test every 2 hours for 3 consecutive target values and then every 4 hours thereafter. If there is a change in the infusion rates, then blood sugar checks will be done every hour and the cycle followed thereafter.\n\nIn the standard sliding scale insulin group, blood sugars will be treated with insulin boluses if the blood sugars go more than 150 mg/dL and blood glucose will be monitored every 4 hours.\n\nThese regimens will be initiated after 2 weeks of in-service training for anesthesiologists, post anesthetic care unit (PACU) and vascular intensive care unit (VICU) nurses. The study investigators will provide this training. Insulin infusion in the tight control regimen will be started through pump piggyback to maintenance intravenous infusion as follows. Insulin infusion bags will be made by the pharmacy (100 units in a 100 ml bag). The anesthesiologists in the operating room and PACU, and VICU nurses will perform blood glucose monitoring, bolus insulin administration, and infusion initiation and rate adjustments as specified by the protocol. Blood glucose levels will be tested by finger stick method or arterial line drop sample.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Abdominal aortic surgery\n* Supra and infrainguinal peripheral vascular bypass surgery\n* Below knee amputations\n* Above knee amputations\n* Diabetics and nondiabetics\n* American Society of Anesthesiologists (ASA) I-III\n\nExclusion Criteria:\n\n* Brittle diabetics\n* ASA 1V,V\n* Second surgery in same admission'}, 'identificationModule': {'nctId': 'NCT00328094', 'briefTitle': 'Glycemic Control to Prevent Cardiac Morbidity in Vascular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Impact of Tight Control of Perioperative Blood Glucose in Patients Undergoing Vascular Surgery on Their Perioperative Cardiovascular and Overall Morbidity and Mortality', 'orgStudyIdInfo': {'id': '2005P-000299'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CII, Continuous Insulin Infusion', 'description': 'Continuous intravenous insulin infusion to control glucose to \\<150 mg/dL in patients undergoing open peripheral vascular bypass surgery', 'interventionNames': ['Drug: continuous intravenous insulin infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IIB, Intermittent insulin boluses', 'description': 'Intermittent intravenous insulin insulin boluses to a blood glucose target of \\<150mg/dL in patients undergoing peripheral vascular bypass surgery', 'interventionNames': ['Drug: continuous intravenous insulin infusion']}], 'interventions': [{'name': 'continuous intravenous insulin infusion', 'type': 'DRUG', 'otherNames': ['CII-continuous insulin infusion', 'II-Intermittent insulin boluses'], 'description': 'Tight glucose control versus standard of care', 'armGroupLabels': ['CII, Continuous Insulin Infusion', 'IIB, Intermittent insulin boluses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Balachundhar Subramaniam', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center, Boston MA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Anesthesiologist', 'investigatorFullName': 'Balachundhar Subramaniam', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}