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Morphological Changes of the Brain by MRI in Chronic Kidney Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02827253
Acronym
KIDBRAIN
Enrollment
100
Registered
2016-07-11
Start date
2016-06-30
Completion date
2019-06-30
Last updated
2017-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

brain, haemodialysis, intradialytic hypotension

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.

Interventions

DEVICEMRI

MRI will be performed during interdialysis period in the haemodialysis group. MRI will be performed at the beginning of the study in predialysis group.

Sponsors

Hospital General Universitario Gregorio Marañon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Morphological changes in gray matter of haemodialysis groupone yeararea (mm2), volume (mm3), mean cortical thick (mm) of each structure of brain
Morphological changes in white matter of haemodialysis groupone yearDiffusion weighted imaging: fractional anisotropy, median diffusivity, radial diffusivity, volume ratio.
Morphological changes in gray matter of predialysis group that start haemodialysissix monthsarea (mm2), volume (mm3), mean cortical thick (mm) of each structure of brain
Morphological changes in white matter of predialysis group that start haemodialysissix monthsDiffusion weighted imaging: fractional anisotropy, median diffusivity, radial diffusivity, volume ratio.

Secondary

MeasureTime frameDescription
Related factors that have influence in morphological changes in haemodialysis groupone yearage (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).
Related factors that have influence in morphological changes in predialysis groupsix monthsage, etiology of CKD, proteinuria, blood pressure, comorbidities.

Countries

Spain

Contacts

Primary ContactJuan M. López Gómez, PhD
juanmlopez@senefro.org678 292 696
Backup ContactSantiago Cedeño Mora, MD
santicedeno@outlook.com692258295

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026