Morphological Changes of the Brain by MRI in Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Statistical analysis will be done with SPSS version 20.

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

Conditions
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Chronic Kidney Disease Requiring Chronic Dialysis

Intervention / Treatment
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* Device: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prevalent patients of haemodialysis (6 months minimum) Patients with CKD (stages 4 and 5) Informed consent signed Exclusion Criteria: Refusion to participate in the study Presence of contraindications for MRI Presence of clinic neurologic disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Predialysis<br>Patients with CKD (4 and 5 stages by KDOQI guidelines) underwent MRI to obtain in vivo images of brain anatomy that were subsequently analyzed by the data processing package FreeSurfer (version 5.3). A MRI 6 months after starting haemodialysis will be performed to analyze changes in gray and white matter of the brain. | Device: MRI<br>* MRI will be performed during interdialysis period in the haemodialysis group. MRI will be performed at the beginning of the study in predialysis group.<br>|
| Haemodialysis<br>Patients with end stage of renal disease (ESRD) in haemodialysis underwent MRI to obtain in vivo images of brain anatomy that were subsequently analyzed by the data processing package FreeSurfer (version 5.3). A one year follow up MRI will be performed to analyze the changes in gray and white matter of the brain. | Device: MRI<br>* MRI will be performed during interdialysis period in the haemodialysis group. MRI will be performed at the beginning of the study in predialysis group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphological changes in gray matter of haemodialysis group | area (mm2), volume (mm3), mean cortical thick (mm) of each structure of brain | one year | 
| Morphological changes in white matter of haemodialysis group | Diffusion weighted imaging: fractional anisotropy, median diffusivity, radial diffusivity, volume ratio. | one year | 
| Morphological changes in gray matter of predialysis group that start haemodialysis | area (mm2), volume (mm3), mean cortical thick (mm) of each structure of brain | six months | 
| Morphological changes in white matter of predialysis group that start haemodialysis | Diffusion weighted imaging: fractional anisotropy, median diffusivity, radial diffusivity, volume ratio. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Related factors that have influence in morphological changes in haemodialysis group | age (years), time in dialysis (months), time of treatment (hours), KtV, convective transport (L/session), anemia (hemoglobin, index resistance erythropoietin), inflammation (PCR), intradialytic hypotension (Nadir90, Nadir100, Fall20, Fall30). | one year | 
| Related factors that have influence in morphological changes in predialysis group | age, etiology of CKD, proteinuria, blood pressure, comorbidities. | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain, haemodialysis, intradialytic hypotension