Morphological Changes of the Brain by MRI in Chronic Kidney Disease

Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial

— KIDBRAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02827253
• Other study ID #: HGUGM
• Status: Recruiting
• Phase: N/A
• First received: June 29, 2016
• Last updated: August 9, 2017
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: August 2017
• Source: Hospital General Universitario Gregorio Marañon
• Contact: Juan M. López Gómez, PhD
• Phone: 678 292 696
• Email: juanmlopez[@]senefro.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

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