Morphological Changes of the Brain by MRI in Chronic Kidney Disease
NCT ID: NCT02827253
Last Updated: 2017-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2016-06-30
2019-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patients with CKD (stages 4 and 5)
* Informed consent signed
Exclusion Criteria
* Presence of contraindications for MRI
* Presence of clinic neurologic disorders
18 Years
80 Years
ALL
No
Sponsors
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Hospital General Universitario Gregorio Marañon
OTHER
Responsible Party
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Juan Manuel López Gómez, PhD
PhD
Principal Investigators
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Juan M. López Gómez, PhD
Role: STUDY_CHAIR
Hospital General Universitario Gregorio Marañon
Santiago Cedeño Mora, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario Gregorio Marañon
Manuel Desco, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario Gregorio Marañon
Locations
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Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Eldehni MT, Odudu A, McIntyre CW. Randomized clinical trial of dialysate cooling and effects on brain white matter. J Am Soc Nephrol. 2015 Apr;26(4):957-65. doi: 10.1681/ASN.2013101086. Epub 2014 Sep 18.
McIntyre CW, Goldsmith DJ. Ischemic brain injury in hemodialysis patients: which is more dangerous, hypertension or intradialytic hypotension? Kidney Int. 2015 Jun;87(6):1109-15. doi: 10.1038/ki.2015.62. Epub 2015 Apr 8.
Other Identifiers
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HGUGM
Identifier Type: -
Identifier Source: org_study_id
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