Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 554
- 试验地点
- 18
- 主要终点
- Incidence density of central nervous system infection
研究概览
简要总结
Resistant microorganisms are public health problems because they affect the treatment of infectious diseases and the survival of patients. Neurosurgical procedures with placement of intracranial pressure monitoring and external ventricular drainage devices are related to increased morbidity and mortality. In Brazil, there are several multicenter studies demonstrating the prevalence and types of resistant microorganisms, however, there is a lack of data related to central nervous system infections associated with invasive devices, which can have a direct impact on prevention and treatment policies.
详细描述
Neurosurgical procedures with placement of devices are related to increased morbidity and mortality. A study shows that the incidence of device-related central nervous system infection can reach 27%. A meta-analysis published in 2015, which included 35 studies, showed an incidence of 11.4 per 1000 catheters-day.
This is a prospective cohort study, including adult patients, in the ICUs of hospitals participating in the IMPACTO MR Platform, who have a catheter device for monitoring intracranial pressure or external ventricular shunt, with infection densities and microbiological profile being evaluated; risk factors; clinical management; costs involved and short- and long-term clinical outcomes
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
- 否
入选标准
- •All patients over 18 years of age admitted to the ICU in the selected hospitals during the study period, using intracranial pressure monitoring catheters and/or external ventricular shunt.
排除标准
- •Diagnosis of brain death.
结局指标
主要结局
Incidence density of central nervous system infection
时间窗: 30 days after study inclusion
Incidence density will be reported as number of CNS infections per 1000 catheters/day, together with 95% CI. Cumulative incidence will also be reported.
次要结局
- Deaths(30 days and 6 months after study inclusion)
- Treatment(30 days after study inclusion)
- Costs(30 days after study inclusion)
- Rankin scale(30 days and 6 months after study inclusion)
- Microbiological characteristics(30 days after study inclusion)
- Risk factors(30 days after study inclusion)
研究者
Viviane Cordeiro Veiga, MD, PhD
Principal Investigator
Beneficência Portuguesa de São Paulo