Clinical and Microbiological Analyses of Infections Following NeuroSurgery: a Retrospective, Single-center Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Number of participants with sepsis/septic shock
研究概览
简要总结
Neurosurgery (NS) is essential for the treatment of various diseases such as malignant tumors, vascular conditions, spinal stenosis or trauma. However, NS can be complicated by the onset of infections, directly related to surgery or to hospitalization.
Little is known regarding the epidemiology, the optimal treatment regimens and the outcome of infections following NS (I-NS).
The study aims at investigating the clinical and microbiological characteristics as well as the outcomes of I-NS occurring at a single Institution (IRCCS Neuromed, Pozzilli, Italy) during the period 2016-2018.
Patients with at least 1 infective episode requiring antimicrobial therapy are included in this retrospective observational study.
详细描述
Neurosurgery (NS) is essential for the treatment of various diseases such as malignant tumors, vascular conditions, spinal stenosis or trauma. However, one of the major complication is the occurrence of infections following NS (I-NS), with reported rate between 0.5% and 15% depending on the type of NS and the presence/absence of foreign bodies (i.e ventricular shunts, brain stimulators, spinal fixation systems).
I-NS might be related to NS and include meningitis, brain abscesses or spinal infections; I-NS might be also related to the hospitalization and include nosocomial pneumonia, bloodstream and urinary tract infections, especially in elder and frail patients.
While risk factors have been investigated in several studies, little is known about the epidemiology, the optimal treatment regimens and the outcomes of I-NS.
The knowledge of the causative agents of I-NS and the local epidemiology might lead to an early initiation of an appropriate and definite antimicrobial therapy, with obvious consequences in terms of treatment failure and mortality reduction, in line with antimicrobial stewardship principles. Moreover, being aware of the outcomes of I-NS might allow the comprehension of the risk factors associated with clinical cure, recurrence or mortality.
Based on these premises, the principal aim of this single-center, retrospective, observational study is to evaluate the clinical and microbiological characteristics as well as the outcomes of I-NS observed at IRCCS Neuromed (Pozzilli, Italy) over the 2016-2018 period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized at IRCCS Neuromed between 2016-2018
- •Patients with at least 1 infective episode
- •Patients receiving antimicrobial therapy
排除标准
- •Patients with incomplete data
结局指标
主要结局
Number of participants with sepsis/septic shock
时间窗: From the date of inclusion until the date of sepsis/septic shock diagnosis, assessed up to 6 months
Sepsis or septic shock at the onset of infection Sepsis includes a life-threatening condition and organ dysfunction induced by a disregulated host response to infection (change ≥2 points in SOFA) and septic shock includes persisting hypotension requiring vasopressors to maintain MAP≥65 mmHg AND serum lactate levels ≥2mmol/L despite adequate liquid support. Collected measurement data will be aggregated as follows: no sepsis/sepsis/septic shock
Number of participants with multi-drug resistant microorganisms
时间窗: From the date of inclusion until the date of antimicrobial susceptibility report availability, assessed up to 6 months
Presence of resistance to \>3 class of antimicrobials, as it appears in the antimicrobial susceptibility report. Collected measurement data will be aggregated as follows: presence/absence of multi-drug resistance
mortality
时间窗: 30-days
Evaluation of mortality of patient with infection.
次要结局
- Correlation of the antimicrobial treatment regimens with the observed outcomes of I-NS(6-months)
- Number of participants with Recurrence of infection(6-months)
研究者
Alessandra Oliva
Principal Investigator
Neuromed IRCCS