Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-12 @ 8:25 AM
Study NCT ID:
NCT00468494
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2007-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-24', 'studyFirstSubmitDate': '2007-04-30', 'studyFirstSubmitQcDate': '2007-05-01', 'lastUpdatePostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glucose level at specific points', 'timeFrame': 'Intraoperatively and in the PACU'}], 'secondaryOutcomes': [{'measure': 'pt telephoned to assess for complications', 'timeFrame': 'within 2 weeks of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['non diabetic', 'catabolic energy state'], 'conditions': ['General Anesthesia', 'Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'Surgery performed during general anesthesia induces a stress effect on the body. Our plan is to identify population at risk of hyperglycemia during perioperative period.', 'detailedDescription': 'This is a prospective study to define the relationship between time profile of glucose control before, during and after surgery with patient variables, surgical variables and anesthetic variables. Serum glucose levels will be measured preoperatively and then at 30 minute intervals during surgery. Pain score, pain medication and glucose levels will be measured in the post anesthesia recovery room. Subjects will be contacted 2 weeks following the date of surgery to determine the incidence of postoperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'non-diabetic adults undergoing surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective surgery\n* 18-80 years of age\n\nExclusion Criteria:\n\n* Known diabetics\n* Pregnant patients\n* Cardiac surgery patients\n* Liver transplant patients'}, 'identificationModule': {'nctId': 'NCT00468494', 'briefTitle': 'Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia?', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia', 'orgStudyIdInfo': {'id': '0120060208'}}, 'contactsLocationsModule': {'locations': [{'zip': '07101', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University of Medicine & Dentistry of New Jersey', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}], 'overallOfficials': [{'name': 'Vasanti Tilak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Medicine & Dentistry of New Jersey-NJMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}