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/dL) with standard care (subcutaneous insulin, 81-180 mg/dL) 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.
Adults aged ≥18 years
Patients undergoing elective cranial neurosurgical procedures classified as clean surgeries
Patients who underwent any surgical or neurosurgical procedure within 30 days prior to enrollment
Presence of active infection at any site
Patients undergoing emergency or urgent neurosurgical procedures
Patients with trauma and exposed brain tissue
Parallel
Intensive glycemic control
Other interventionThe 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/exclusion 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 24/7 support. Insulin will be administered via continuous IV infusion to maintain blood glucose between 140-180 mg/dL, 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
Hypokalemia Prevention Protocol During IV Insulin Therapy
Other interventionDuring 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/L. In cases of hyperkalemia (≥5.0 mEq/L), 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.
Glucose-Supported Intravenous Insulin Infusion Protocol
Other interventionContinuous 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.
primary outcome - surgical site infection
Incidence of surgical site infection (SSI) within 90 days after surgery, defined according to CDC (2024) criteria.
Primary Outcome
Surgical site infections will be assessed during hospitalization through wound evaluation on alternate days, with photographic documentation. After discharge, follow-up will occur via telephone and outpatient visits. Suspected cases will be investigated with clinical assessment, cultures, and imaging when indicated. Diagnosis will follow CDC (2024) criteria and be reviewed by an adjudication committee.
Hypoglycemia
Number of participants with hypoglycemia (\<70 mg/dL) within 90 days postoperatively. Assessment: Identified through capillary glucose measurements recorded in electronic medical records.
Severe Hypoglycemia
Number of participants with severe hypoglycemia (\<54 mg/dL) within 90 days postoperatively. Assessment: Recorded via capillary glucose measurements and clinical documentation.
Hyperglycemia
Number of participants with hyperglycemia (\>180 and \<250 mg/dL) within 90 days postoperatively. Assessment: Based on capillary glucose measurements documented in medical records.
Severe Hyperglycemia
Number of participants with severe hyperglycemia (≥250 mg/dL) within 90 days postoperatively. Assessment: Identified through glucose monitoring records.
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