NCT02827253

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

June 29, 2016

Last Update Submit

August 9, 2017

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

brainhaemodialysisintradialytic hypotension

Outcome Measures

Primary Outcomes (4)

  • Morphological changes in gray matter of haemodialysis group

    area (mm2), volume (mm3), mean cortical thick (mm) of each structure of brain

    one year

  • Morphological changes in white matter of haemodialysis group

    Diffusion weighted imaging: fractional anisotropy, median diffusivity, radial diffusivity, volume ratio.

    one year

  • 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

  • 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 Outcomes (2)

  • Related factors that have influence in morphological changes in haemodialysis group

    one year

  • Related factors that have influence in morphological changes in predialysis group

    six months

Study Arms (2)

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

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

Interventions

MRIDEVICE

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

HaemodialysisPredialysis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Prevalent patients of haemodialysis (6 months minimum)
  • Patients with CKD (stages 4 and 5)
  • Informed consent signed

You may not qualify if:

  • Refusion to participate in the study
  • Presence of contraindications for MRI
  • Presence of clinic neurologic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

Related 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.

    PMID: 25234925BACKGROUND

  • 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.

    PMID: 25853331BACKGROUND

Study Officials

  • Juan M. López Gómez, PhD

    Hospital General Universitario Gregorio Marañon

    STUDY CHAIR

  • Santiago Cedeño Mora, MD

    Hospital General Universitario Gregorio Marañon

    PRINCIPAL INVESTIGATOR

  • Manuel Desco, PhD

    Hospital General Universitario Gregorio Marañon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan M. López Gómez, PhD

CONTACT

678 292 696juanmlopez@senefro.org

Santiago Cedeño Mora, MD

CONTACT

692258295santicedeno@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 11, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2019

Last Updated

August 10, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

publication of design of the study

Locations

ES(1)