Surgical Site Infection (SSI)Brain SugarNCT07548112
Effects of Intensive Glycemic Control in the Postoperative Period of Neurosurgical Patients on the Incidence of Surgical Site Infection
A study testing Hypokalemia Prevention Protocol During IV Insulin Therapy and Glucose-Supported Intravenous Insulin Infusion Protocol in people with Surgical Site Infection (SSI), run by University of Sao Paulo.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection (SSI)
- What is being tested?
- Hypokalemia Prevention Protocol During IV Insulin Therapy and Glucose-Supported Intravenous Insulin Infusion Protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years
- Patients undergoing elective cranial neurosurgical procedures classified as clean surgeries
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Alessandra Yuri Takehana de Andrade yuri Andrade, Lead Researcher contact
About this study
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.
Read the detailed description
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.
- Conditions
- Surgical Site Infection (SSI)
- Being tested
- Intensive glycemic control, Hypokalemia Prevention Protocol During IV Insulin Therapy, Glucose-Supported Intravenous Insulin Infusion Protocol
- Keywords
- Nursing, Surgical Site Infection, Neurosurgery, Glycemic Control
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive glycemic controlOther
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
Hypokalemia Prevention Protocol During IV Insulin TherapyOther
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.
Glucose-Supported Intravenous Insulin Infusion ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Glycemic Control | Experimental | Intensive glycemic control, with insulin administered via infusion pump to maintain blood glucose between 140 and 180 mg/dL. Receives: Other: Intensive glycemic control; Other: Hypokalemia Prevention Protocol During IV Insulin Therapy; Other: Glucose-Supported Intravenous Insulin Infusion Protocol |
| Control | No intervention | Conventional glycemic control, with insulin administered subcutaneously to maintain blood glucose between 81 and 180 mg/dL. |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome - surgical site infection
Incidence of surgical site infection (SSI) within 90 days after surgery, defined according to CDC (2024) criteria.
Measured: 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.
Measured: 90 days
Secondary outcomes (7)
Hypoglycemia
Number of participants with hypoglycemia (<70 mg/dL) within 90 days postoperatively.
Assessment: Identified through capillary glucose measurements recorded in electronic medical records.
Measured: 90 days
Severe Hypoglycemia
Number of participants with severe hypoglycemia (<54 mg/dL) within 90 days postoperatively.
Assessment: Recorded via capillary glucose measurements and clinical documentation.
Measured: 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.
Measured: 90 days
Severe Hyperglycemia
Number of participants with severe hyperglycemia (≥250 mg/dL) within 90 days postoperatively.
Assessment: Identified through glucose monitoring records.
Measured: 90 days
ICU Length of Stay
Length of postoperative ICU stay (in days), measured from ICU admission to discharge.
Measured: 90 days
Hospital Length of Stay
Total hospital length of stay (in days), measured from admission to hospital discharge.
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start5 Apr 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site Infection (SSI)Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Yuri Takehana de Andrade, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548112
- Sponsor's protocol ID
- 94853126.3.0000.5392
- Acronym
- Brain Sugar
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Glycemic Control in the Postoperative Period of Neurosurgical Patients on the Incidence of Surgical Site Infection
- ClinicalTrials.gov ID
- NCT07548112
- Acronym / sponsor ID
- Brain Sugar / 94853126.3.0000.5392
- Conditions
- Surgical Site Infection (SSI)
- Keywords
- Nursing, Surgical Site Infection, Neurosurgery, Glycemic Control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 572 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 5 Apr 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Glycemic Control | Experimental | Other: Intensive glycemic control, Other: Hypokalemia Prevention Protocol During IV Insulin Therapy, Other: Glucose-Supported Intravenous Insulin Infusion ProtocolIntensive glycemic control, with insulin administered via infusion pump to maintain blood glucose between 140 and 180 mg/dL. |
| Control | No intervention | –Conventional glycemic control, with insulin administered subcutaneously to maintain blood glucose between 81 and 180 mg/dL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged ≥18 years
- Patients undergoing elective cranial neurosurgical procedures classified as clean surgeries
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive glycemic controlThe 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 | Intensive Glycemic Control |
| Hypokalemia Prevention Protocol During IV Insulin TherapyDuring 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 | Intensive Glycemic Control |
| Glucose-Supported Intravenous Insulin Infusion ProtocolContinuous 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. | Other | Intensive Glycemic Control |
Primary outcome
primary outcome - surgical site infection
Time frame: 90 days
Incidence of surgical site infection (SSI) within 90 days after surgery, defined according to CDC (2024) criteria.
Primary Outcome
Time frame: 90 days
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.
7 secondary outcomes
Hypoglycemia
Time frame: 90 days
Severe Hypoglycemia
Time frame: 90 days
Hyperglycemia
Time frame: 90 days
Severe Hyperglycemia
Time frame: 90 days
ICU Length of Stay
Time frame: 90 days
Hospital Length of Stay
Time frame: 90 days
All-cause Mortality
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandra Yuri Takehana de Andrade yuri Andrade, Lead Researcher contact
Questions about this trial
What is this clinical trial studying?
A study testing Hypokalemia Prevention Protocol During IV Insulin Therapy and Glucose-Supported Intravenous Insulin Infusion Protocol in people with Surgical Site Infection (SSI), run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Yuri Takehana de Andrade yuri Andrade, Lead Researcher (+5511987594903, alessandra.andrade@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcome - surgical site infection (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.