Cohort Study of Morphological Changes of the Brain by MRI in Chronic Kidney Disease Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Morphological changes in gray matter of predialysis group that start haemodialysis
研究概览
简要总结
The purpose of this study is to describe brain´s morphological changes induced by chronic kidney disease (CKD) in advanced stages (stages 4 and 5 defined by KDOQI guidelines) and also by haemodialysis using MRI.
Based on the hypothesis that hypotension may cause damage in some organs including brain the investigators study if intradialytic hypotension (IDH) causes any type of changes in gray and white matter of the brain.
详细描述
There will be two groups: one in haemodialysis treatment and the other with chronic kidney disease patients in advanced stages (stages 4 and 5 defined by KDOQI guidelines).
Both groups will be evaluated with a MRI without contrast. A second MRI to identify brain´s morphological changes will be performed in patients of the first group a year later and in patients of the second group that will have been begun haemodialysis six months after.
In a first transverse evaluation, eighteen haemodialysis sessions from the first group will be studied with a retrospective analysis. The first three sessions of each month for six months before the MRI will be considered.
In each session the investigators will collect haemodynamic variables (systolic arterial blood pressure pre and post dialysis), intradialytic hypotension based on different definitions (Nadir90, Nadir100, Fall20, Fall30) and proper haemodialysis variables (KtV, convective transport).
In the first group and patients with CKD that will start haemodialysis, the investigators analyse the variables considered in the transverse evaluation until complete one year follow up.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prevalent patients of haemodialysis (6 months minimum)
- •Patients with CKD (stages 4 and 5)
- •Informed consent signed
排除标准
- •Refusion to participate in the study
- •Presence of contraindications for MRI
- •Presence of clinic neurologic disorders
结局指标
主要结局
Morphological changes in gray matter of predialysis group that start haemodialysis
时间窗: six months
area (mm2), volume (mm3), mean cortical thick (mm) of each structure of brain
Morphological changes in white matter of haemodialysis group
时间窗: one year
Diffusion weighted imaging: fractional anisotropy, median diffusivity, radial diffusivity, volume ratio.
Morphological changes in gray matter of haemodialysis group
时间窗: one year
area (mm2), volume (mm3), mean cortical thick (mm) of each structure of brain
Morphological changes in white matter of predialysis group that start haemodialysis
时间窗: six months
Diffusion weighted imaging: fractional anisotropy, median diffusivity, radial diffusivity, volume ratio.
次要结局
- Related factors that have influence in morphological changes in predialysis group(six months)
- Related factors that have influence in morphological changes in haemodialysis group(one year)
研究者
Juan Manuel López Gómez, PhD
PhD
Hospital General Universitario Gregorio Marañon
