Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-22 @ 7:07 AM
Study NCT ID:
NCT05236751
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2022-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperglycemia in Neurosurgery
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-24', 'studyFirstSubmitDate': '2022-02-02', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative infection', 'timeFrame': '7 days after surgery', 'description': 'Proportion of patients diagnosed with infection (such as wound, pulmonary, urological, blood) in the postoperative period'}], 'secondaryOutcomes': [{'measure': 'Antibiotic prophylaxis scheme', 'timeFrame': 'Preoperatively', 'description': 'Types of antibiotics administered preoperatively abstracted from electronic medical records.'}, {'measure': 'Intraoperative glucose level in whole blood', 'timeFrame': 'before incision and at the end of surgery', 'description': 'Twice intraoperatively abstracted from electronic medical records'}, {'measure': 'Intraoperative dose of insulin', 'timeFrame': 'During surgical procedure', 'description': 'Abstracted from electronic medical records'}, {'measure': 'Dosages and regimen of dexamethasone in the perioperative period', 'timeFrame': 'preoperative clinic visit to within 7 days of surgery', 'description': 'Abstracted from electronic medical records'}, {'measure': 'Perioperative complications', 'timeFrame': 'preoperative clinic visit to within 7 days of surgery', 'description': 'Perioperative complications (such as episodes of hemodynamic instability, blood loss) abstracted from electronic medical records'}, {'measure': 'Duration of stay in ICU in hours', 'timeFrame': '30 days', 'description': 'Abstracted from electronic medical records'}, {'measure': 'Duration of stay in hospital in days', 'timeFrame': '30 days', 'description': 'Abstracted from electronic medical records'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intraoperative hyperglycemia', 'Postoperative infection', 'Neurosurgical patient', 'Open surgical intracranial intervention', 'Endoscopic intracranial intervention'], 'conditions': ['Hyperglycemia', 'Postoperative Infection']}, 'descriptionModule': {'briefSummary': 'Poor glycemic control is recognized as a risk factor for postoperative infection. For the neurosurgical patient, postoperative infection can lead to devastating complications such as meningitis, encephalitis and death. Neurosurgical patients often receive high doses of medications that increase blood glucose levels such as steroids, placing them at a potentially higher risk for postoperative infection. The purpose of this multisite observational study is to assess the impact of severe intraoperative hyperglycemia as a risk factor for postoperative infection in the neurosurgical patient.', 'detailedDescription': "This is a multisite \\[3 locations\\] prospective observational study of adult patients (18-89 years old) scheduled for elective intracranial (open or endoscopic) procedures that require general anesthesia and a hospital stay of at least 1 day after the surgery. All sites will follow the standard of care clinical protocol for glycemic management that was developed at Boston Medical Center (BMC). Laboratory tests will be collected at the discretion of the primary clinician. This observational study does not require any change to routine clinical practice.\n\nThe following perioperative data (timeframe between Pre-Procedure Clinic visit through Post-Anesthesia Care Unit discharge): blood glucose measurements, total insulin dose, total dexamethasone dose, estimated intraoperative blood loss, antibiotic prophylaxis regimen.\n\nThe patient's electronic medical records data will be reviewed 7 days after the neurosurgical procedure to abstract all available culture data (blood, urine, sputum, CSF), available treatment regimen data prescribed for infection (antibiotics), complications from hyperglycemia (diabetic ketoacidosis, hyperglycemic nonketotic coma) or insulin therapy (hypoglycemia episodes). Intensive care unit (ICU) and hospital length of stay will also be obtained form the medical records.\n\nThe investigators anticipate finding four groups of patients with regards to intraoperative blood glucose levels and management: 1) patients with no episodes of severe intraoperative hyperglycemia, 2) patients with intraoperative hyperglycemia who received insulin treatment, 3) patients with intraoperative hyperglycemia who did not receive insulin treatment and 4) patients with no available laboratory data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (18-89 years at the time of surgery) scheduled for elective intracranial (open surgical or endoscopic) intervention and require general anesthesia and a hospital stay of at least 1 day post-procedure.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients scheduled for elective intracranial (open surgical or endoscopic) intervention\n* General anesthesia\n* Hospital stay of at least 1 day post-procedure\n\nExclusion Criteria:\n\n* Diagnosis of infection (local or systemic) in preoperative period\n* Emergency procedures'}, 'identificationModule': {'nctId': 'NCT05236751', 'briefTitle': 'Hyperglycemia in Neurosurgery', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions', 'orgStudyIdInfo': {'id': 'H-41050'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elective intracranial intervention patients', 'description': 'Adult patients (18-89 years at the time of surgery) scheduled for elective intracranial (open surgical or endoscopic) intervention and require general anesthesia and a hospital stay of at least one day post-procedure.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Sapienza University', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Burdenko Neurosurgery Institute', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Robert J Canelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, {'name': 'Burdenko Neurosurgery Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}