Effects of Intensive Glycemic Control in the Postoperative Period of Neurosurgical Patients on the Incidence of Surgical Site Infection
Brain Sugar
1 other identifier
interventional
572
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2026
CompletedStudy Start
First participant enrolled
April 5, 2026
CompletedFirst Posted
Study publicly available on registry
April 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
April 23, 2026
March 1, 2026
1.4 years
March 27, 2026
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (7)
Hypoglycemia
90 days
Severe Hypoglycemia
90 days
Hyperglycemia
90 days
Severe Hyperglycemia
90 days
ICU Length of Stay
90 days
- +2 more secondary outcomes
Study Arms (2)
Intensive Glycemic Control
EXPERIMENTALIntensive glycemic control, with insulin administered via infusion pump to maintain blood glucose between 140 and 180 mg/dL.
Control
NO INTERVENTIONConventional glycemic control, with insulin administered subcutaneously to maintain blood glucose between 81 and 180 mg/dL.
Interventions
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
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.
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.
Eligibility Criteria
You may qualify if:
- Adults aged ≥18 years
- Patients undergoing elective cranial neurosurgical procedures classified as clean surgeries
You may not qualify if:
- 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
- Diagnosis of diabetic ketoacidosis
- Blood glucose levels \>600 mg/dL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Alessandra Yuri Takehana de Andrade yuri Andrade, Lead Researcher
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, RN, MsC
Study Record Dates
First Submitted
March 27, 2026
First Posted
April 23, 2026
Study Start
April 5, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
April 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Upon the presence of signs of surgical site infection at the surgical site.
- Access Criteria
- 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.
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.