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NESRD
Combination of Neuroimaging and Metabolomics of Brain Impairment in Patients With End-stage Renal Disease: a Multi-center Prospective Cohort Study
Sponsor study identifier
observational
192
1 country
1
Study Start
July 1, 2019
Actual (reported)Primary Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 26, 2019
Actual (reported)May 23, 2019
Actual (reported)July 1, 2019
Actual (reported)December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
serum metabolomics
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061, China
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.
Ming Zhang, PhD
First Affiliated Hospital of Xian Jiaotong University
First Submitted
April 26, 2019
First Posted
May 23, 2019
Study Start
July 1, 2019
Actual (reported)Primary Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 28, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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