[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635086":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":20,"centralContacts":34,"locations":20,"responsibleParty":44,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":20,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":20},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intensive Glycemic Control","EXPERIMENTAL","Intensive glycemic control, with insulin administered via infusion pump to maintain blood glucose between 140 and 180 mg\u002FdL.",[13,14,15],"Other: Intensive glycemic control","Other: Hypokalemia Prevention Protocol During IV Insulin Therapy","Other: Glucose-Supported Intravenous Insulin Infusion Protocol",{"label":17,"type":18,"description":19,"interventionNames":20},"Control","NO_INTERVENTION","Conventional glycemic control, with insulin administered subcutaneously to maintain blood glucose between 81 and 180 mg\u002FdL.",null,[22,26,30],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":20},"Intensive glycemic control","The interventions will be conducted in a structured and supervised manner to ensure safety, traceability, and risk management. Before data collection, the ICU multidisciplinary team-including nurses, technicians, physicians, and physiotherapists-will receive training on the study protocol, operational flows for glucose monitoring, inclusion\u002Fexclusion criteria, insulin preparation and administration, aseptic techniques, infection control, and complication management. Nurses will play a key role, monitoring patients, checking labs, and reporting adverse events. The lead researcher will provide continuous oversight, data review, and 24\u002F7 support. Insulin will be administered via continuous IV infusion to maintain blood glucose between 140-180 mg\u002FdL, following validated institutional protocols. Safety measures include hourly glucose checks, potassium monitoring, and interventions for hypo- or hyperglycemia. The protocol will be suspended if medically indicated, for patient transfer, or at",[9],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":20},"Hypokalemia Prevention Protocol During IV Insulin Therapy","During intravenous insulin infusion, a hypokalemia prevention strategy will be implemented through the administration of a glucose solution combined with potassium chloride (KCl) and sodium chloride (NaCl), according to the current medical prescription. Insulin will only be initiated after confirmation of recent laboratory tests (≤24 hours) and serum potassium \\>3.5 mEq\u002FL. In cases of hyperkalemia (≥5.0 mEq\u002FL), potassium replacement will be withheld, maintaining insulin infusion with a glucose solution, with serum potassium reassessed after 2 hours. Serum potassium monitoring will be performed at protocol initiation, after 2 hours, and subsequently every 6 hours or as clinically indicated.",[9],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":20},"Glucose-Supported Intravenous Insulin Infusion Protocol","Continuous intravenous insulin infusion will be initiated concomitantly with caloric support a glucose solution. The glucose concentration and infusion rate will be determined by the attending medical team according to each patient's clinical and metabolic status.",[9],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":20,"email":39},"Alessandra Yuri Takehana de Andrade yuri Andrade, Lead Researcher","CONTACT","+5511987594903","alessandra.andrade@einstein.br",{"name":41,"role":37,"phone":42,"phoneExt":20,"email":43},"Vanessa de Brito Poveda Poveda, Researcher","11997876690","vbpoveda@usp.br",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Alessandra Yuri Takehana de Andrade","Principal Investigator, RN, MsC","100635086","effects-of-intensive-glycemic-control-in-the-postoperative-period-of-neurosurgical-patients-on-the-incidence-of-surgical-site-infection-100635086",false,"NCT07548112","Effects of Intensive Glycemic Control in the Postoperative Period of Neurosurgical Patients on the Incidence of Surgical Site Infection","Brain Sugar","Inclusion Criteria\n\n* Adults aged ≥18 years\n* Patients undergoing elective cranial neurosurgical procedures classified as clean surgeries\n\nExclusion Criteria:\n\n* Patients who underwent any surgical or neurosurgical procedure within 30 days prior to enrollment\n* Presence of active infection at any site\n* Patients undergoing emergency or urgent neurosurgical procedures\n* Patients with trauma and exposed brain tissue\n* Diagnosis of diabetic ketoacidosis\n* Blood glucose levels \\>600 mg\u002FdL","ALL","18 Years",{"count":58,"type":59},572,"ESTIMATED","INTERVENTIONAL",[62],"NA","Surgical site infections (SSIs) are frequent complications in neurosurgical patients, often worsened by perioperative hyperglycemia. This randomized, controlled trial will compare intensive glycemic control (continuous insulin infusion, 140-180 mg\u002FdL) with standard care (subcutaneous insulin, 81-180 mg\u002FdL) in 544 patients. The primary outcome is SSI occurrence within 90 days post-surgery. Results aim to guide optimal glycemic management for SSI prevention in neurosurgery.",[65],"Surgical Site Infection (SSI)",[67,68,69,70],"Nursing","Surgical Site Infection","Neurosurgery","Glycemic Control","NOT_YET_RECRUITING","2026-04-20",{"date":74,"type":75},"2026-04-23","ACTUAL",{"date":77,"type":59},"2026-04-05",{"date":79,"type":59},"2027-10",{"name":5,"class":6}]