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Neuroimaging and End Stage Renal Disease (NESRD)

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Xi'an Jiaotong University

Status

Unknown

Conditions

End Stage Renal Disease

Treatments

Device: magnetic resonance image (MRI)

Study type

Observational

Funder types

Other

Identifiers

NCT03961724
XJTU1AF-CRF-2018-006

Details and patient eligibility

About

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.

Enrollment

192 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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.

Trial design

192 participants in 2 patient groups

ESRD group
Treatment:
Device: magnetic resonance image (MRI)
Control group
Treatment:
Device: magnetic resonance image (MRI)

Trial contacts and locations

1

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Central trial contact

Shaohui Ma, MD; Ming Zhang, PhD

Data sourced from clinicaltrials.gov

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