Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Postoperative infection
研究概览
简要总结
Poor glycemic control is recognized as a risk factor for postoperative infection. For the neurosurgical patient, postoperative infection can lead to devastating complications such as meningitis, encephalitis and death. Neurosurgical patients often receive high doses of medications that increase blood glucose levels such as steroids, placing them at a potentially higher risk for postoperative infection. The purpose of this multisite observational study is to assess the impact of severe intraoperative hyperglycemia as a risk factor for postoperative infection in the neurosurgical patient.
详细描述
This is a multisite [3 locations] prospective observational study of adult patients (18-89 years old) scheduled for elective intracranial (open or endoscopic) procedures that require general anesthesia and a hospital stay of at least 1 day after the surgery. All sites will follow the standard of care clinical protocol for glycemic management that was developed at Boston Medical Center (BMC). Laboratory tests will be collected at the discretion of the primary clinician. This observational study does not require any change to routine clinical practice.
The following perioperative data (timeframe between Pre-Procedure Clinic visit through Post-Anesthesia Care Unit discharge): blood glucose measurements, total insulin dose, total dexamethasone dose, estimated intraoperative blood loss, antibiotic prophylaxis regimen.
The patient's electronic medical records data will be reviewed 7 days after the neurosurgical procedure to abstract all available culture data (blood, urine, sputum, CSF), available treatment regimen data prescribed for infection (antibiotics), complications from hyperglycemia (diabetic ketoacidosis, hyperglycemic nonketotic coma) or insulin therapy (hypoglycemia episodes). Intensive care unit (ICU) and hospital length of stay will also be obtained form the medical records.
The investigators anticipate finding four groups of patients with regards to intraoperative blood glucose levels and management: 1) patients with no episodes of severe intraoperative hyperglycemia, 2) patients with intraoperative hyperglycemia who received insulin treatment, 3) patients with intraoperative hyperglycemia who did not receive insulin treatment and 4) patients with no available laboratory data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients scheduled for elective intracranial (open surgical or endoscopic) intervention
- •General anesthesia
- •Hospital stay of at least 1 day post-procedure
排除标准
- •Diagnosis of infection (local or systemic) in preoperative period
- •Emergency procedures
结局指标
主要结局
Postoperative infection
时间窗: 7 days after surgery
Proportion of patients diagnosed with infection (such as wound, pulmonary, urological, blood) in the postoperative period
次要结局
- Intraoperative glucose level in whole blood(before incision and at the end of surgery)
- Intraoperative dose of insulin(During surgical procedure)
- Perioperative complications(preoperative clinic visit to within 7 days of surgery)
- Duration of stay in ICU in hours(30 days)
- Antibiotic prophylaxis scheme(Preoperatively)
- Dosages and regimen of dexamethasone in the perioperative period(preoperative clinic visit to within 7 days of surgery)
- Duration of stay in hospital in days(30 days)