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临床试验/NCT04285359
NCT04285359已完成不适用

Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions

Burdenko Neurosurgery Institute2 个研究点 分布在 2 个国家目标入组 514 人开始时间: 2020年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
514
试验地点
2
主要终点
Infection rate

研究概览

简要总结

Severe intraoperative hyperglycemia (SIH) is recognized as one of the important risk factors for the increasing of the postoperative infections rate, which can negatively affect the final outcome of surgical treatment. Studies in recent years have shown a much higher incidence of wound infections, respiratory and urinary tract infections in patients who intraoperatively had an increase in blood glucose level (BGL) above 180 mg/dl (10 mmol/l). This problem in neurosurgery is especially important due to the high proportion of patients with acute injuries and potentially long-term need for postoperative intensive care, as well as the frequent use of drugs that increase blood glucose level (steroids) in neurooncology. Most published studies include patients from both of these groups. This study is aimed to assess the impact of severe intraoperative hyperglycemia on the incidence of infectious complications only in patients scheduled for elective intracranial interventions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (>18 years) scheduled for elective intracranial (open or endoscopic) intervention.

排除标准

  • Diagnosis of infection (local or systemic) in preoperative period; urgent intervention.

结局指标

主要结局

Infection rate

时间窗: 7 days after surgery

Proportion of patients diagnosed with infection (wound, pulmonary, urological, blood etc.) in the postoperative period according to CDC.

次要结局

  • History of steroids usage(Preoperatively)
  • Glucose level(Twice intraoperatively: before incision and at the end of surgery)
  • Complications(Intraoperatively)
  • Treatment outcome(30 days)
  • Antibiotic prophylaxis(Preoperatively)
  • Insulin dosage(Intraoperatively)
  • Duration of stay in ICU and hospital(30 days)

研究者

发起方
Burdenko Neurosurgery Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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