Morphological Changes of the Brain by MRI in Chronic Kidney Disease (KIDBRAIN)

August 9, 2017 updated by: Juan Manuel López Gómez, PhD, Hospital General Universitario Gregorio Marañon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Haemodialysis group: 2 dialysis units. Predialysis group: clinic of advanced chronic renal disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Predialysis
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
MRI will be performed during interdialysis period in the haemodialysis group. MRI will be performed at the beginning of the study in predialysis group.
Haemodialysis
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
MRI will be performed during interdialysis period in the haemodialysis group. MRI will be performed at the beginning of the study in predialysis group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphological changes in gray matter of haemodialysis group
Time Frame: one year
area (mm2), volume (mm3), mean cortical thick (mm) of each structure of brain
one year
Morphological changes in white matter of haemodialysis group
Time Frame: one year
Diffusion weighted imaging: fractional anisotropy, median diffusivity, radial diffusivity, volume ratio.
one year
Morphological changes in gray matter of predialysis group that start haemodialysis
Time Frame: six months
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
Time Frame: six months
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
Time Frame: 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).
one year
Related factors that have influence in morphological changes in predialysis group
Time Frame: six months
age, etiology of CKD, proteinuria, blood pressure, comorbidities.
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Gregorio Marañon

Investigators

  • Study Chair: Juan M. López Gómez, PhD, Hospital General Universitario Gregorio Marañon
  • Principal Investigator: Santiago Cedeño Mora, MD, Hospital General Universitario Gregorio Marañon
  • Principal Investigator: Manuel Desco, PhD, Hospital General Universitario Gregorio Marañon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGUGM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

publication of design of the study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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