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Effects of Intensive Glycemic Control in the Postoperative Period of Neurosurgical Patients on the Incidence of Surgical Site Infection

NCT07548112 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2026-04-23

No results posted yet for this study

Summary

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.

Conditions

  • Surgical Site Infection (SSI)

Interventions

OTHER

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/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

OTHER

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/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.

OTHER

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.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-05
Primary Completion
2027-09-30
Completion
2027-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07548112 on ClinicalTrials.gov