Neuroimaging and End Stage Renal Disease

NCT03961724 | Unknown

• 1 other identifier: XJTU1AF-CRF-2018-006
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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%. 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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• Change from baseline brain structure measures at 3 months and 12months

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

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

• Change from baseline brain function measures at 3 months and 12months

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

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

Secondary Outcomes (4)

• Changes from baseline cognitive condition at 3 months and 12months

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

• Changes from baseline depression condition at 3 months and 12months

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

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

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

• Changes from baseline serum metabolomics at 3 months and 12months

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

Study Arms (2)

ESRD group

Device: magnetic resonance image (MRI)

Control group

Device: magnetic resonance image (MRI)

Interventions

magnetic resonance image (MRI) DEVICE

serum metabolomics

Also known as: serum

Control group; ESRD group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• 215 Hospital of Shaanxi NI: collaborator
• Baoji Zhongxin Hospital: collaborator
• Taihe Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 41552885 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ming Zhang, PhD

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Zhang, PhD

CONTACT

0086-18991232265; zmmri@163.com

Shaohui Ma, MD

CONTACT

0086-15029215781; sh_ma@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 23, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)