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临床试验/NCT01923571
NCT01923571Unknown不适用

Blood Glucose Concentration During Craniotomy: Epidemiology and Relationship With Postoperative Infections

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
53
试验地点
2
主要终点
Blood glucose control during craniotomy: epidemiology and relationship with postoperative infections

研究概览

简要总结

Intraoperative blood glucose concentration abnormalities are associated with increased perioperative morbidity and mortality (1-4). Severe intraoperative hyperglycemia (BGC ≥ 200 mg/dl) in patients undergoing craniotomy for urgent/emergent craniotomy after traumatic brain injury complicates 15% of the cases and is associated with higher in-hospital mortality. Intraoperative use of dexamethasone during craniotomy is also known to induce an increase in blood glucose concentration.

The importance of blood glucose concentration in neurosurgical patients is witnessed by the effects of tight blood glucose control on incidence of infections and neurological outcome . Currently available evidence suggest that, in neurosurgical patients, perioperative BGC values should be within the 80-180 mg/dl range .

Data on the prevalence of severe intraoperative hyper (blood glucose concentration >180 mg/dl) and hypoglycemia (blood glucose concentration <80 mg/dl) in patients undergoing craniotomy for supra or infratentorial surgery as elective or emergency procedure are lacking as it is not known whether in these patients intraoperative severe hyperglycemia relates to an increased incidence of postoperative infections is unknown.

Aim of this prospective observational study -in patients undergoing craniotomy for supra or infratentorial surgery as elective or emergency procedure- was to test the hypothesis that severe intraoperative hyperglycemia (blood glucose concentration ≥180mg/dl) is associated with an increased incidence of infections within the first postoperative week (pneumonia, sepsis, urinary and wound and cerebral infections). We also recorded the prevalence of severe intraoperative hyper and hypoglycemia (blood glucose concentration<80 mg/dl) in recruited patients.

详细描述

METHODS Study Design This prospective observational cohort study, in adult patients who underwent craniotomy for supra or infratentorial surgery as elective or emergency procedure, was approved by the University of Rome "Sapienza", Policlinico Umberto I hospital, Institutional Review Board (2665, 28/3/2013). Recruited patients were categorized according the type of procedure into 4 groups: primary brain tumors (gliomas and meningiomas); metastatic tumors; neurovascular lesions (intracranial hemorrhage, subarachnoid hemorrhage, arterovenous malformation); traumatic brain injury (14-16). In each group "elective" and "emergency" procedures were recorded apart. Because of the observational study design, perioperative clinical management was run by the attending anesthesiologist. Standard of care guidelines do not include the use of insulin infusion should full nutritional supply is not provided.

Patients population Adults ≥18 years of age, who underwent elective or emergency craniotomy for brain lesions in the supra or infratentorial space were prospectively recruited. In all patients intraoperative blood glucose concentration was measured twice: at the beginning of the procedure (immediately after endotracheal intubation) and at the end of surgery (immediately before extubation) on arterial whole blood by blood gas analysis (Instrumentation Laboratory, BGA analyzer GEM 4000, UK). Patients with one or both BGC>180 mg/dl were categorized as having "severe intraoperative hyperglycemia".

Intraoperative Setting All patients received normal saline (NaCl 0.9%) as pre and intraoperative fluid infusion. There was no fixed protocol for the anesthetic management and the anesthetic regime was determined by the attending anesthesiologist. Anesthesia was maintained with either halogenated inhalational anaesthetics (desflurane or sevoflurane) or with continuous propofol infusion and fentanyl as per clinical needs. Intraoperative monitoring was accomplished with 3 leads ECG, SpO2, end tidal CO2, invasive arterial pressure, core body temperature and urine output. Patients were normoventilated (PaCO2 35-40 mmHg) and mild hyperventilation was used to facilitate brain relaxation only when necessary . There was no dedicated protocol for treatment of intraoperative hyperglycemia and intraoperative insulin use was discouraged unless the attending anesthesiologist considered it necessary. Recorded demographic and clinical characteristics included: age, gender, localization of the brain lesion (supra or infratentorial), type of surgery (primary brain tumors, metastatic brain tumors, neurovascular, traumatic brain), setting of surgery (elective or emergent), duration of surgery, history of diabetes mellitus (and the use of chronic oral hypoglycemic agents or insulin), associated cardiac, vascular, renal or hepatic morbidity the intraoperative use of mannitol and steroids. In the postoperative period, all patients were kept fasting for the first 24 hours, subsequently full calories load -by self alimentation or enteral/parenteral nutrition- was warranted. As per local protocol, in the postoperative period, insulin was administered only in patients with blood glucose concentration> 180 mg/dl.

Definitions Hyperglycemia was defined as BGC ≥ 180 mg/dL. Hypoglycemia was defined as glucose≤ 80 mg/dL. Postoperative infections (pneumonia, blood stream-sepsis, urinary, surgical site/wound and cerebral infections) diagnosed according to Center for Disease Control and Prevention criteria within 7 days after surgery . The onset and type of infection was determined by 2 consultants for infective disease.

Outcomes The primary outcome was the prevalence of postoperative infections in normoglycemic patients and in those that presented at one intraoperative blood glucose concentration ≥ 180 mg/dL.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing craniotomy

排除标准

  • age <18 years

结局指标

主要结局

Blood glucose control during craniotomy: epidemiology and relationship with postoperative infections

时间窗: 7 postoperative days

次要结局

  • Incidence of postoperative infections according the CDC criteria up to the 7th postoperative day(7th postoperative day)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Bilotta

MD, PhD

University of Roma La Sapienza

研究点 (2)

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