Chronic Kidney Disease Requiring Chronic DialysisKIDBRAINNCT02827253
Morphological Changes of the Brain by MRI in Chronic Kidney Disease
An observational study of Chronic Kidney Disease Requiring Chronic Dialysis, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Haemodialysis group: 2 dialysis units. Predialysis group: clinic of advanced chronic renal disease.
Who may be able to join
- Prevalent patients of haemodialysis (6 months minimum)
- Patients with CKD (stages 4 and 5)
- Informed consent signed
Who cannot join
- Refusion to participate in the study
- Presence of contraindications for MRI
- Presence of clinic neurologic disorders
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Juan López Gomez, PhD, 678 292 696, juanmlopez@senefro.org
Santiago Cedeño Mora, MD, 692258295, santicedeno@outlook.com
About this study
Official title: 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.
Read the 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.
- Being tested
- MRI
- Keywords
- brain, haemodialysis, intradialytic hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphological changes in gray matter of haemodialysis group
area (mm2), volume (mm3), mean cortical thick (mm) of each structure of brain
Measured: one year
Morphological changes in white matter of haemodialysis group
Diffusion weighted imaging: fractional anisotropy, median diffusivity, radial diffusivity, volume ratio.
Measured: 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
Measured: six months
Morphological changes in white matter of predialysis group that start haemodialysis
Diffusion weighted imaging: fractional anisotropy, median diffusivity, radial diffusivity, volume ratio.
Measured: six months
Secondary outcomes (2)
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).
Measured: one year
Related factors that have influence in morphological changes in predialysis group
age, etiology of CKD, proteinuria, blood pressure, comorbidities.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Manuel López Gómez, PhD, Hospital General Universitario Gregorio Marañon
- Investigators
- Juan M. López Gómez, PhD, Study chair, Hospital General Universitario Gregorio MarañonSantiago Cedeño Mora, MD, Principal investigator, Hospital General Universitario Gregorio MarañonManuel Desco, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827253
- Sponsor's protocol ID
- HGUGM
- Acronym
- KIDBRAIN
- Status last verified
- Aug 2017
- First submitted
- 29 Jun 2016
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: publication of design of the study
Publications
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.
PubMed 25234925McIntyre 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.
PubMed 25853331
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Morphological Changes of the Brain by MRI in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT02827253
- Acronym / sponsor ID
- KIDBRAIN / HGUGM
- Keywords
- brain, haemodialysis, intradialytic hypotension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Predialysis | – | Device: MRIPatients 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. |
| Haemodialysis | – | Device: MRIPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Haemodialysis group: 2 dialysis units. Predialysis group: clinic of advanced chronic renal disease.
Key inclusion criteria (3 listed)
- Prevalent patients of haemodialysis (6 months minimum)
- Patients with CKD (stages 4 and 5)
- Informed consent signed
Key exclusion criteria (3 listed)
- Refusion to participate in the study
- Presence of contraindications for MRI
- Presence of clinic neurologic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI will be performed during interdialysis period in the haemodialysis group. MRI will be performed at the beginning of the study in predialysis group. | Device | Haemodialysis, Predialysis |
Primary outcome
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
Morphological changes in white matter of haemodialysis group
Time frame: one year
Diffusion weighted imaging: fractional anisotropy, median diffusivity, radial diffusivity, volume ratio.
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
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.
2 secondary outcomes
Related factors that have influence in morphological changes in haemodialysis group
Time frame: one year
Related factors that have influence in morphological changes in predialysis group
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Background: PubMed 25234925Eldehni 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.
- Background: PubMed 25853331McIntyre 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.
- Individual participant dataSharing planned: Yes. publication of design of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan M. López Gómez, PhD study chair
Hospital General Universitario Gregorio Marañon
Santiago Cedeño Mora, MD principal investigator
Hospital General Universitario Gregorio Marañon
Manuel Desco, PhD principal investigator
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease Requiring Chronic Dialysis, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan M. López Gómez, PhD (678 292 696, juanmlopez@senefro.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphological changes in gray matter of haemodialysis group (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02827253, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.