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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.
Surgical site infections (SSIs) are common complications, contributing to increased morbidity, prolonged hospital stays, and higher healthcare costs. Neurosurgical patients are at an elevated risk of SSIs, particularly when exposed to perioperative hyperglycemia-a common condition due to the inflammatory response to surgical stress and corticosteroid use. However, there is still limited evidence regarding the effectiveness of intensive glycemic control in preventing these infections.
Objective: To investigate the impact of an intensive glycemic control regimen during the postoperative period, compared to the standard institutional protocol, on the occurrence of surgical site infections in patients undergoing neurosurgery.
Methods: This is a randomized, controlled, parallel clinical trial that will include patients undergoing neurosurgery, allocated into two groups: intensive glycemic control (continuous insulin infusion with a target of 140-180 mg/dL) and standard control (subcutaneous insulin correction with a target glycemic range of 81-180 mg/dL). The study will be conducted in a general SUS hospital, with 272 participants per group, assuming a 25% treatment effect, α = 5%, and 80% power. Randomization will be performed by an independent statistician, using a software-generated table, with 1:1 allocation in opaque, numbered, sealed envelopes. Only the statistician and the adjudication committee will remain blinded to the analyses. The primary outcome will be the occurrence of SSI up to the 90th day after the surgical procedure.
Expected Results: The findings are expected to provide evidence on the most effective interventions for neurosurgical patients regarding glycemic control and SSI prevention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Glycemic Control | Experimental | Intensive glycemic control, with insulin administered via infusion pump to maintain blood glucose between 140 and 180 mg/dL. |
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| Control | No Intervention | Conventional glycemic control, with insulin administered subcutaneously to maintain blood glucose between 81 and 180 mg/dL. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive glycemic control | Other | 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/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 |
| Measure | Description | Time Frame |
|---|---|---|
| primary outcome - surgical site infection | Incidence of surgical site infection (SSI) within 90 days after surgery, defined according to CDC (2024) criteria. | 90 days |
| 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia | Number of participants with hypoglycemia (<70 mg/dL) within 90 days postoperatively. Assessment: Identified through capillary glucose measurements recorded in electronic medical records. | 90 days |
| Severe Hypoglycemia |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandra Yuri Takehana de Andrade yuri Andrade, Lead Researcher | Contact | +5511987594903 | alessandra.andrade@einstein.br | |
| Vanessa de Brito Poveda Poveda, Researcher | Contact | 11997876690 | vbpoveda@usp.br |
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For the assessment of the primary outcome (surgical site infection), photographic records documenting the progression of the surgical wound, together with clinical and laboratory data, will be shared with an independent adjudication committee.
Upon the presence of signs of surgical site infection at the surgical site.
Photographic records documenting the progression of the surgical wound, along with clinical and laboratory data, will be made available to an independent adjudication committee composed of experts in infection control and surgical site infections. The data will be securely shared with the committee via Google Drive.
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| Hypokalemia Prevention Protocol During IV Insulin Therapy | Other | 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/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. |
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| Glucose-Supported Intravenous Insulin Infusion Protocol | Other | 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. |
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Number of participants with severe hypoglycemia (<54 mg/dL) within 90 days postoperatively.
Assessment: Recorded via capillary glucose measurements and clinical documentation.
| 90 days |
| 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. | 90 days |
| Severe Hyperglycemia | Number of participants with severe hyperglycemia (≥250 mg/dL) within 90 days postoperatively. Assessment: Identified through glucose monitoring records. | 90 days |
| ICU Length of Stay | Length of postoperative ICU stay (in days), measured from ICU admission to discharge. | 90 days |
| Hospital Length of Stay | Total hospital length of stay (in days), measured from admission to hospital discharge. | 90 days |
| All-cause Mortality | All-cause mortality within 90 days after the procedure. Assessment: Verified through medical records, death certificates, and telephone follow-up if necessary. | 90 days |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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