NCT07380477招募中不适用
CSF Lactate and Ventriculostomy Associated Infections in Patients With Acute Brain Injury - a Prospective, Observational Cohort Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Concentration of cerebrospinal fluid lactate
研究概览
简要总结
This observational study involving patients with acute brain injury undergoing treatment with an external ventricular drain consists of three subprojects, aiming to:
- investigate various biomarkers, with a primary focus on the development of cerebrospinal fluid lactate in relation to ventriculostomy-associated infection;
- compare proximal and distal sample results obtained from an external ventricular drain;
- describe the natural progression of various biomarkers in blood and cerebrospinal fluid following acute brain injury.
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
- •Age >18 years
- •EVD in situ
- •Admission to the neuro-ICU or neurosurgical step-down unit at Rigshospitalet, Denmark
- •Diagnosis of acute brain injury categorized as traumatic brain injury, subarachnoid haemorrhage, intracranial haemorrage, intraventricular haemorrhage
排除标准
- •Patient or closest relatives do not understand written and spoken Danish or English
- •Patients transferred to Rigshospitalet with an EVD
- •Patients with brain injury due to existing brain infection (e.g., meningitis, intracranial empyema or abscess, encephalitis)
- •Patients with existing ventriculoperitoneal or ventriculoatrial shunt at the time of admission
- •Patients with primary or secondary brain cancer
- •Patients died or in palliative care
结局指标
主要结局
Concentration of cerebrospinal fluid lactate
时间窗: Throughout the external ventricular drain duration (1-60 days)
in patients with compared to patients without positive CSF culture, and for b. patients with both a positive CSF culture and a distinct drop in the level of consciousness compared to patients with negative CSF culture and a stable level of consciousness.
次要结局
- CSF lactate concentration change in patients developing ventriculostomy associated infection(Throughout the external ventricular drain duration (1-60 days))
- Functional outcome at six months(6 months after the initial brain injury)
- Comparison of concentration of cerebrospinal fluid markers drawn from the proximal and distal port of the EVD(Throughout the external ventricular drain duration (1-60 days))
研究者
Pernille Rosenfeldt
MD, PhD-student
Rigshospitalet, Denmark
研究点 (1)
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