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End Stage Renal DiseaseNESRDNCT03961724

Neuroimaging and End Stage Renal Disease

An observational study of End Stage Renal Disease, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Brain impairment is one of the common complications of end-stage renal disease (ESRD). The patients always present with various cerebrovascular diseases, cognitive impairment and sensorimotor abnormalities, with morbidity over 40%. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
End Stage Renal Disease
What is being tested?
magnetic resonance image (MRI)
Type of treatment
Medical device
How many people
192 participants
Where
1 siteChina
Study dates
1 Jul 2019to 31 Dec 2022
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: All of the patients of ESRD group are in-patients and out-patients in the nephrology department from three research centers. The subjects of control group are recruited from community.

Who may be able to join

  • Diagnosis with end stage renal disease before dialysis initiation
  • Chronic renal failure
  • Chronic renal failure
  • 18-55 years old
  • Right handedness

Who cannot join

  • Concurrent severe infection
  • With other severe diseases
  • History of central nervous system diseases, such as mental disorder, degenerative diseases of central nervous system, tumors, trauma, etc.
  • History of alcohol dependence and drug abuse
  • History of brain operation
  • Loss of vision or hearing
Show all 9Show fewer
  • Psychotropic medication in three months
  • Contraindication of MRI examination, such as metal implants and claustrophobia, and other reasons that cannot cooperate with MRI examination
  • Cerebrovascular diseases which can be detected from conventional MR images, including the size of cerebral hemorrhage over 10 mm, infarction over 20 mm, subarachnoid hemorrhage, subdural hemorrhage and extradural hemorrhage.

Trial locations and contacts

1 site in 1 country.

Ming Zhang, PhD contact

0086-18991232265

zmmri@163.com

Shaohui Ma, MD contact

0086-15029215781

sh_ma@163.com

China1 site, 1 recruiting

  • First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061

    Ming Zhang, PhD, 0086-18991232265, zmmri@163.com

    Shaohui Ma, MD, 0086-15029215781, zhangming01@xjtu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Combination of Neuroimaging and Metabolomics of Brain Impairment in Patients With End-stage Renal Disease: a Multi-center Prospective Cohort Study

Brain impairment is one of the common complications of end-stage renal disease (ESRD). The patients always present with various cerebrovascular diseases, cognitive impairment and sensorimotor abnormalities, with morbidity over 40%. However, the risk factors and the neural mechanisms of brain injury in ESRD is still unclear. Identifying the risk factors and finding objective and reliable biomarkers of brain impairment in the process of ESRD is an important clinical problem. At the same time, to find the neural mechanisms of brain damage in ESRD is a serious scientific problem. Neuroimaging techniques based on multi-modal magnetic resonance image (MRI) can detect the structural and functional brain abnormalities objectively and sensitively, especially for those without obvious clinical symptoms. Through the deep analysis of brain MRI data, it is helpful for studying the neural mechanisms of brain damage in ESRD in the perspective from brain science. In addition, the accumulation of uremic toxins is supposed to play an essential role in the brain impairment of ESRD. The metabolomics is a useful method in detecting the uremic toxins with different molecular weights. In this study, the investigators will collect the brain MRI, serum metabolomics and cognitive assessment data before the dialysis initiation, and then will make prospective longitudinal observation of changes of brain impairment during the dialysis. Thus, combining analysis of neuroimaging and metabolomics will provide more information for finding the risk factors and imaging diagnostic markers of brain impairment in ESRD. It will also helpful for explaining the underlying mechanisms of brain impairment in ESRD, providing an objective basis for clinical diagnosis and prediction of the prognosis.

Being tested
magnetic resonance image (MRI)
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • magnetic resonance image (MRI)Device

    Also called serum

    serum metabolomics

Study groups in NCT03961724
Study groupRoleWhat they receive
ESRD groupNot described
Receives: Device: magnetic resonance image (MRI)
Control groupNot described
Receives: Device: magnetic resonance image (MRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline brain structure measures at 3 months and 12months

    The changes of brain volume (mm3) are evaluated by structural MRI

    Measured: baseline (before dialysis initiation), hemodialysis for 3 months and 12 months

  2. Change from baseline brain function measures at 3 months and 12months

    The changes of brain functional connectivity intensity are evaluated by functional MRI

    Measured: baseline (before dialysis initiation), hemodialysis for 3 months and 12 months

Secondary outcomes (4)

  1. Changes from baseline cognitive condition at 3 months and 12months

    The cognitive condition is assessed by Montreal cognitive assessment (MoCA). The MoCA assesses several cognitive domains: 1) visuospatial and executive abilities are assessed using a trail-making test B (1 point), clock-drawing task (3 points) and a cube copy (1 point); 2) naming is assessed with low-familiarity animals (3 points); 3) the short-term memory (5 points) involves two learning trials of five nouns; 4) attention are evaluated using a sustained attention task (1 point), a serial subtraction task (3 points), and digits forward and backward (1 point each); 5) language is assessed using a repetition of two syntactically complex sentences (2 points), and the verbal fluency task (1 point); 6) orientation to time and place is evaluated by asking the subject for the date and the city (6 points). The scale ranges is from 0 to 30, and score of 26 or over is considered to be normal. Subscales are summed to compute a total score, and higher values represent a better outcome.

    Measured: baseline (before dialysis initiation), hemodialysis for 3 months and 12 months

  2. Changes from baseline depression condition at 3 months and 12months

    The affective complaints are assessed by Beck depression inventory (BDI). The BDI is a 21-question multiple-choice self-report inventory in the past week, for measuring the severity of depression. The BDI is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex. Each question had a set of at least four possible responses, ranging in intensity: (0) I do not feel sad; (1) I feel sad; (2) I am sad all the time and I can't snap out of it; (3) I am so sad or unhappy that I can't stand it. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is summed to be compared to a key to determine the depression's severity. The scale ranges is from 0 to 63, and the higher total scores indicate more severe depressive symptoms.

    Measured: baseline (before dialysis initiation), hemodialysis for 3 months and 12 months

  3. Changes from baseline anxiety condition at 3 months and 12months

    The affective complaints are assessed by Beck anxiety inventory (BAI). The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. The questions used in this measure ask about common symptoms of anxiety that the subject has had during the past week (including the day you take it) (such as numbness and tingling, sweating not due to heat, and fear of the worst happening). The BAI contains 21 questions, each answer being scored on a scale value of 1 (not at all) ,2 (mild), 3 (moderate), to 4 (severely). The scale ranges is from 21 to 84 , and higher total scores indicate more severe anxiety symptoms.

    Measured: baseline (before dialysis initiation), hemodialysis for 3 months and 12 months

  4. Changes from baseline serum metabolomics at 3 months and 12months

    The serum metabolomics are conducted by liquid Chromatograph Mass Spectrometer (LC-MS), mainly including the molecules of uremic toxins.

    Measured: baseline (before dialysis initiation), hemodialysis for 3 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2019
  2. Study start1 Jul 2019
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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
192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03961724
Sponsor's protocol ID
XJTU1AF-CRF-2018-006
Acronym
NESRD
Status last verified
Apr 2022
First submitted
26 Apr 2019
Last updated
28 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu X, Ma S, Liu S, Luo Z, Zhu Q, Yuan H, Zhu X, Gu W, Li P, Zhang J, Zhang M, Mu J. Structural Connectivity Disruption and Structural-Functional Decoupling in Working Memory Networks Across Pre-Dialysis and Maintenance Hemodialysis End-Stage Renal Disease Patients. CNS Neurosci Ther. 2026 Jan;32(1):e70761. doi: 10.1002/cns.70761.

    PubMed 41552885

Questions about this trial

What is this clinical trial studying?

An observational study of End Stage Renal Disease, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

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 5 inclusion and 9 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 28 Apr 2022. 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 China. 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 Ming Zhang, PhD (0086-18991232265, zmmri@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline brain structure measures at 3 months and 12months (time frame: baseline (before dialysis initiation), hemodialysis for 3 months and 12 months). The study lists 2 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 NCT03961724, which also lists 1 linked publication.

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 28 Apr 2022.

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