Clinical trial NCT02827253: Morphological Changes of the Brain by MRI in Chronic Kidney Disease
Official title: Cohort Study of Morphological Changes of the Brain by MRI in Chronic Kidney Disease Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: brain
haemodialysis
intradialytic hypotension
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Haemodialysis group: 2 dialysis units. Predialysis group: clinic of advanced chronic renal disease.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morphological changes in gray matter of haemodialysis group
timeFrame: one year
measure: Morphological changes in white matter of haemodialysis group
timeFrame: one year
measure: Morphological changes in gray matter of predialysis group that start haemodialysis
timeFrame: six months
measure: Morphological changes in white matter of predialysis group that start haemodialysis
timeFrame: six months
Secondary outcomes:
measure: Related factors that have influence in morphological changes in haemodialysis group
timeFrame: one year
measure: Related factors that have influence in morphological changes in predialysis group
timeFrame: six months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
Study officials:
affiliation: Hospital General Universitario Gregorio Marañon
name: Juan M. López Gómez, PhD
role: STUDY_CHAIR
affiliation: Hospital General Universitario Gregorio Marañon
name: Santiago Cedeño Mora, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario Gregorio Marañon
name: Manuel Desco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.