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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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,
• Другое 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 s
• Другое 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.

Первичные конечные точки

• primary outcome - surgical site infection [Срок оценки: 90 days]
• Primary Outcome [Срок оценки: 90 days]

Вторичные конечные точки (7)

• Hypoglycemia [Срок оценки: 90 days]
• Severe Hypoglycemia [Срок оценки: 90 days]
• Hyperglycemia [Срок оценки: 90 days]
• Severe Hyperglycemia [Срок оценки: 90 days]
• ICU Length of Stay [Срок оценки: 90 days]
• Hospital Length of Stay [Срок оценки: 90 days]
• All-cause Mortality [Срок оценки: 90 days]

Критерии участия

Критерии включения

• Adults aged ≥18 years
• Patients undergoing elective cranial neurosurgical procedures classified as clean surgeries

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07548112 · 94853126.3.0000.5392

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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