Neuroimaging and End Stage Renal Disease

End Stage Renal Disease Clinical Trial

— NESRD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03961724
• Other study ID #: XJTU1AF-CRF-2018-006
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Ming Zhang, PhD
• Phone: 0086-18991232265
• Email: zmmri[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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%. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• magnetic resonance image (MRI)
serum metabolomics

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xian	Shaanxi

Sponsors (4)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Baoji Zhongxin Hospital, NO.215 Hospital of Shaanxi Nuclear Industry, Taihe Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	baseline (before dialysis initiation), hemodialysis for 3 months and 12 months
Secondary	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.	baseline (before dialysis initiation), hemodialysis for 3 months and 12 months
Secondary	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.	baseline (before dialysis initiation), hemodialysis for 3 months and 12 months
Secondary	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.	baseline (before dialysis initiation), hemodialysis for 3 months and 12 months