Neuroimaging and End Stage Renal Disease

NCT ID: NCT03961724

Last Updated: 2022-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ESRD group

magnetic resonance image (MRI)

Intervention Type DEVICE

serum metabolomics

Control group

magnetic resonance image (MRI)

Intervention Type DEVICE

serum metabolomics

Interventions

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magnetic resonance image (MRI)

serum metabolomics

Intervention Type DEVICE

Other Intervention Names

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serum

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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215 Hospital of Shaanxi NI

OTHER

Sponsor Role collaborator

Baoji Zhongxin Hospital

UNKNOWN

Sponsor Role collaborator

Taihe Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xian Jiaotong University

Locations

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First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ming Zhang, PhD

Role: CONTACT

0086-18991232265

Shaohui Ma, MD

Role: CONTACT

0086-15029215781

Facility Contacts

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Ming Zhang, PhD

Role: primary

0086-18991232265

Shaohui Ma, MD

Role: backup

0086-15029215781

Other Identifiers

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XJTU1AF-CRF-2018-006

Identifier Type: -

Identifier Source: org_study_id

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