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临床试验/NCT02827253
NCT02827253Unknown不适用

Cohort Study of Morphological Changes of the Brain by MRI in Chronic Kidney Disease Patients

Hospital General Universitario Gregorio Marañon1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年6月最近更新:
适应症

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

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

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan Manuel López Gómez, PhD

PhD

Hospital General Universitario Gregorio Marañon

研究点 (1)

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