Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary endpoint will be the change in CSF ionogram between day 0 and day 14 according to the occurrence of hyponatremia.
研究概览
简要总结
Hyponatremia is a frequent complication of subarachnoid hemorrhage (SAH) with a prevalence of 30 to 50% in patients with this condition. This hydro-electrolytic disorder is responsible for an increase in morbidity with the appearance of neurological disorders.
Also, it has been shown that there are ionic changes in the cerebrospinal fluid and a probable alteration of the blood-brain barrier in patients with SAH. The kinetics and relationship between hyponatremia and these changes remain unknown.
The main objective of the study is to determine whether the change in cerebrospinal fluid (CSF) composition, precedes the development of hyponatremia. For this, the investigators propose to study the evolution of the CSF ionogram with the blood ionogram. Furthermore, they will perform additional analyses on the basis of a control group (CSF of patient with normal pressure hydrocephalus) to determine the effect of SAH on ionic changes.
The hypothesis of the study is that there is a correlation between the change in CSF blood ionogram and the development of hyponatremia between day 0 and day 14.
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
- •SAH group :
- •Hospitalized in the neurological intensive care unit for a Fisher modified aneurysmal SAH 3 or 4 with EVD and urinary catheter.
- •With a catheter (arterial or venous) for repeated sampling.
- •Control group :
- •Performing a perfusion test in the operating room for normal pressure hydrocephalus
排除标准
- •Patients with SAH without EVD.
- •Patients with non-aneurysmal SAH.
- •Pregnant or breastfeeding women.
- •Patients under legal protection, guardianship, curatorship, safeguard of justice.
- •Patients participating in a study that may interfere with the present study.
- •Persons under forced psychiatric care.
结局指标
主要结局
The primary endpoint will be the change in CSF ionogram between day 0 and day 14 according to the occurrence of hyponatremia.
时间窗: The patient is included during hospitalization within 2 days of the placement of the EVD
次要结局
未报告次要终点