Diagnostic Significance of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis : a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Comparison of Sensitivity of CSF D-Lactate for Ventriculostomy-Related Nosocomial Meningitis
研究概览
简要总结
The TOTEM study is a single-center study designed to evaluate the performance of the D-lactate assay in cerebrospinal fluid (CSF) for the diagnosis of ventriculostomy-related nosocomial meningitis. The study will be conducted in the neurosurgical intensive care unit of the Toulouse University Hospital, in patients with a suspected diagnosis of ventriculostomy-related nosocomial meningitis.
详细描述
For each study participant, an additional CSF sample will be taken from the ventriculostomy during the routine sampling performed for the diagnosis of nosocomial meningitis. This sample will be stored at -80°C. Assays of D-lactate, procalcitonin (PCT), and pro-inflammatory cytokines (IL-1, IL-6, IL-8, TNFa) will be performed serially on these CSF samples.
If the CSF sample taken at inclusion does not meet the criteria for nosocomial meningitis, a second sample will be taken 48 to 96 hours later to reassess the cellularity of the CSF. Finally, the end-of-participation visit takes place after 4 weeks. Two neurosurgical reanimators will retrospectively diagnose nosocomial meningitis, or the absence of meningitis, according to the information from the patient's medical records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age ⩾ 18 years.
- •Patient with an external ventriculostomy implanted at the Toulouse University Hospital.
- •Patient suspected of nosocomial meningitis due to a febrile syndrome (in the absence of any other identified infectious site), headache, nausea, lethargy, change in neurological status, meningeal syndrome, epileptic event and cutaneous or subcutaneous inflammation at the ventriculostomy site of insertion.
- •Patient having expressed oral consent, after free and informed information.
- •Patient affiliated to a social security scheme.
排除标准
- •Diagnosis of community meningitis.
- •Proven or suspected meningitis and/or ventriculitis during the previous month.
- •Diagnosis of nosocomial meningitis made in another medical centre prior to admission.
- •Short bowel syndrome.
- •Acute mesenteric ischaemia.
- •End-stage renal failure (GFR < 15 ml/min/m2).
- •Peritoneal dialysis.
- •Patient participating in another research protocol with an exclusion period still in progress.
- •Pregnant or breastfeeding woman.
- •Patient under guardianship or trusteeship, persons placed under the protection of justice
研究组 & 干预措施
Ventriculostomy-related nosocomial meningitis
Finally, two neurosurgical reanimators will retrospectively diagnose nosocomial meningitis, or the absence of meningitis, according to the information from the patient's medical records.
干预措施: CSF sample (Biological)
Absence of nosocomial meningitis
Finally, two neurosurgical reanimators will retrospectively diagnose nosocomial meningitis, or the absence of meningitis, according to the information from the patient's medical records.
干预措施: CSF sample (Biological)
结局指标
主要结局
Comparison of Sensitivity of CSF D-Lactate for Ventriculostomy-Related Nosocomial Meningitis
时间窗: Day 0
Calculation of the sensitivity obtained for the determination of CSF D-lactate in patients with suspected ventriculostomy-related nosocomial meningitis. Thes parameter will be compared with those obtained for the usual biological markers.
Comparison of Specificity of CSF D-Lactate for Ventriculostomy-Related Nosocomial Meningitis
时间窗: Day 0
Calculation of the specificity obtained for the determination of CSF D-lactate in patients with suspected ventriculostomy-related nosocomial meningitis. Thes parameter will be compared with those obtained for the usual biological markers.
次要结局
- sensitivity Parameter of Combined D-Lactate and Pro-Inflammatory Cytokines in CSF(Day 0)
- specificity Parameter of Combined D-Lactate and Pro-Inflammatory Cytokines in CSF(Day 0)
- Sensitivity Parameter of D-lactate in CSF depending on the nature of the bacterial species identified.(Day 0)
- Sensitivity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis.(Day 0)
- specificity Parameter of D-lactate and cyto-biochemical parameters in CSF.(Day 0)
- specificity Parameter of D-lactate in CSF depending on the nature of the bacterial species identified.(Day 0)
- Sensitivity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection.(Day 0)
- specificity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection.(Day 0)
- specificity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis.(Day 0)
- Sensitivity Parameter of Combined D-Lactate and and cyto-biochemical parameters in CSF.(Day 0)