Morphological Changes of the Brain by MRI in Chronic Kidney Disease

• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
• Interventions: Device: MRI

• Registration Number: NCT02827253
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-11
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-10
• Primary Completion: 2018-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Predialysis	MRI	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.
Haemodialysis	MRI	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Related factors that have influence in morphological changes in predialysis group	six months	age, etiology of CKD, proteinuria, blood pressure, comorbidities.
Related factors that have influence in morphological changes in haemodialysis group	one year	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).

Trial Locations

Locations (1)

Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain