Clinical trial NCT03961724: Neuroimaging and End Stage Renal Disease
Official title: Combination of Neuroimaging and Metabolomics of Brain Impairment in Patients With End-stage Renal Disease: a Multi-center Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Disease
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: 215 Hospital of Shaanxi NI
name: Baoji Zhongxin Hospital
name: Taihe Hospital
First posted: 2019-05-23
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline brain structure measures at 3 months and 12months
timeFrame: baseline (before dialysis initiation), hemodialysis for 3 months and 12 months
measure: Change from baseline brain function measures at 3 months and 12months
timeFrame: baseline (before dialysis initiation), hemodialysis for 3 months and 12 months
Secondary outcomes:
measure: Changes from baseline cognitive condition at 3 months and 12months
timeFrame: baseline (before dialysis initiation), hemodialysis for 3 months and 12 months
measure: Changes from baseline depression condition at 3 months and 12months
timeFrame: baseline (before dialysis initiation), hemodialysis for 3 months and 12 months
measure: Changes from baseline anxiety condition at 3 months and 12months
timeFrame: baseline (before dialysis initiation), hemodialysis for 3 months and 12 months
measure: Changes from baseline serum metabolomics at 3 months and 12months
timeFrame: baseline (before dialysis initiation), hemodialysis for 3 months and 12 months
Other outcomes:
Locations:
city: Xian
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Ming Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: