Effects of Intensive Glycemic Control in the Postoperative Period of Neurosurgical Patients on th… (NCT07548112) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Intensive Glycemic Control in the Postoperative Period of Neurosurgical Patients on the Incidence of Surgical Site Infection
572 participantsStarted 2026-04-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Adults aged ≥18 years
* Patients undergoing elective cranial neurosurgical procedures classified as clean surgeries
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
primary outcome - surgical site infection
Timeframe: 90 days
2
Primary Outcome
Timeframe: 90 days
Trial details
NCT IDNCT07548112
SponsorUniversity of Sao Paulo
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-09
Contact for this trial
Alessandra Yuri Takehana de Andrade yuri Andrade, Lead Researcher