Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-01-01 @ 9:20 PM
Study NCT ID:
NCT04285359
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2020-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions
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', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 514}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2020-02-22', 'studyFirstSubmitQcDate': '2020-02-24', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infection rate', 'timeFrame': '7 days after surgery', 'description': 'Proportion of patients diagnosed with infection (wound, pulmonary, urological, blood etc.) in the postoperative period according to CDC.'}], 'secondaryOutcomes': [{'measure': 'Antibiotic prophylaxis', 'timeFrame': 'Preoperatively', 'description': 'Antibiotic usage for prevention of postop infection: type and dosage'}, {'measure': 'Glucose level', 'timeFrame': 'Twice intraoperatively: before incision and at the end of surgery', 'description': 'Intraoperative glucose level in whole blood'}, {'measure': 'History of steroids usage', 'timeFrame': 'Preoperatively', 'description': 'Dosages and regimen of dexamethasone in the perioperative period'}, {'measure': 'Insulin dosage', 'timeFrame': 'Intraoperatively', 'description': 'Intraoperative dose of insulin'}, {'measure': 'Complications', 'timeFrame': 'Intraoperatively', 'description': 'Perioperative complications (episodes of hemodynamic instability, blood loss, etc.)'}, {'measure': 'Duration of stay in ICU and hospital', 'timeFrame': '30 days', 'description': 'Length of stay in ICU (in hours) and in hospital (in days) after surgical intervention'}, {'measure': 'Treatment outcome', 'timeFrame': '30 days', 'description': 'Outcome at the moment of discharge (improved,unchanged, worsened, death)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperglycemia', 'Craniotomy', 'Infection Post Op']}, 'referencesModule': {'references': [{'pmid': '35051950', 'type': 'DERIVED', 'citation': 'Kulikov A, Krovko Y, Nikitin A, Shmigelsky A, Zagidullin T, Ershova O, Gadzhieva O, Bilotta F. Severe Intraoperative Hyperglycemia and Infectious Complications After Elective Brain Neurosurgical Procedures: Prospective Observational Study. Anesth Analg. 2022 Nov 1;135(5):1082-1088. doi: 10.1213/ANE.0000000000005912. Epub 2022 Jan 20.'}]}, 'descriptionModule': {'briefSummary': 'Severe intraoperative hyperglycemia (SIH) is recognized as one of the important risk factors for the increasing of the postoperative infections rate, which can negatively affect the final outcome of surgical treatment. Studies in recent years have shown a much higher incidence of wound infections, respiratory and urinary tract infections in patients who intraoperatively had an increase in blood glucose level (BGL) above 180 mg/dl (10 mmol/l). This problem in neurosurgery is especially important due to the high proportion of patients with acute injuries and potentially long-term need for postoperative intensive care, as well as the frequent use of drugs that increase blood glucose level (steroids) in neurooncology. Most published studies include patients from both of these groups. This study is aimed to assess the impact of severe intraoperative hyperglycemia on the incidence of infectious complications only in patients scheduled for elective intracranial interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (\\>18 years) scheduled for elective intracranial intervention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients (\\>18 years) scheduled for elective intracranial (open or endoscopic) intervention.\n\nExclusion Criteria:\n\nDiagnosis of infection (local or systemic) in preoperative period; urgent intervention.'}, 'identificationModule': {'nctId': 'NCT04285359', 'briefTitle': 'Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Burdenko Neurosurgery Institute'}, 'officialTitle': 'Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions', 'orgStudyIdInfo': {'id': 'PPN-2020-02-06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intracranial Interventions', 'type': 'PROCEDURE', 'description': 'Neurosurgical elective intracranial interventions: supra- and infratentorial craniotomies, transnasal endoscopic interventions.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Roma', 'country': 'Italy', 'facility': 'Sapienza University of Rome', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '125047', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Autonomous Institution "N .N. Burdenko National Medical Research Center of Neurosurgery" of the Ministry of Healthcare of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Alexander Kulikov', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Burdenko National Medical Research Center of Neurosurgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Burdenko Neurosurgery Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}