Interaction Research on Cognitive Impairment and Emotional Disorder in End-stage Renal Disease
1 other identifier
observational
50
1 country
2
Brief Summary
End stage renal disease (ESRD) is the last stage (stage 5) of chronic kidney disease (CKD). Abnormalities of cognitive function and high levels of depression or anxiety incidence are characteristic of hemodialysis patients. In this research project, the investigators subject in ESRD patients starting hemodialysis as the carrier. Based on the longitudinal research design, using multimodal neuroimaging data，combining with the interact relationship between changes of brain morphology, the dysfunction of resting-state and-task state with cognitive impairment and abnormal emotions.Establish brain structure-function change model associated with dialysis progression, Explore imaging markers of central and disease development characteristics in ESRD patients. the investigators attempt to clarify the core mechanism of kidney-brain axis damage, thus provide evidence for early cognitive-behavioral therapy to CKD patient.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2017
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2016
CompletedStudy Start
First participant enrolled
June 15, 2017
CompletedFirst Posted
Study publicly available on registry
June 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedJuly 14, 2017
July 1, 2017
2 years
June 22, 2016
July 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in cognitive function
Cognitive testing will be performed for assessment
Change from Baseline to 3 Months after dialysis
Secondary Outcomes (1)
Change in brain MRI
Change from Baseline to 3 Months after dialysis
Study Arms (2)
Control Group
Health adults with no evidence of brain lesions on conventional magnetic resonance imaging(MRI) and no neural developmental disorders.
Patients Group
ESRD patients pre-hemodialysis will be collected.The following exclusion criteria were applied in this study: (a)history of drug or alcohol abuse, (b) brain lesions such as a tumor or stroke assessed on the basis of medical history, (c) history of or current psychiatric disorders, and (d) head motion more than 1.0 mm or 1.0°during magnetic resonance imaging. All patients completed laboratory tests to evaluate renal function,serum creatinine, and urea levels within the 12 hours before magnetic resonance imaging.
Eligibility Criteria
ESRD patients before dialysis initiation
You may qualify if:
- Age 18-50 years;
- ESRD patients who will start hemodialysis
- High quality MRI scan;
- dextromanual
You may not qualify if:
- Diabetes,Brain tumor,brain trauma
- Neuropsychiatric disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
First affiliated hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2016
First Posted
June 19, 2017
Study Start
June 15, 2017
Primary Completion
June 15, 2019
Study Completion
June 30, 2019
Last Updated
July 14, 2017
Record last verified: 2017-07