The Cohort Study of Cognitive Impairment in Chinese Hemodialysis Patients

Cognitive Impairment Clinical Trial

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Official title:

The Cohort Study of Cognitive Impairment and Its Association With Clinical Outcomes in Chinese Maintenance Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251573
• Other study ID #: Z161100002616005
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: June 18, 2019

Study information

• Verified date: July 2019
• Source: Beijing Shijitan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study is going to apply neuropsychological battery tests to measure cognitive function across multiple cognitive domains in our cohort of 600 maintenance hemodialysis patients and evaluate:

1. The presence and patterns of cognitive impairment in domains of executive function, perceptual-motor function, language, learning and memory, and complex attention;

2. Clinical characteristics of participants with and without cognitive impairment;

3. the risk factors which might be related to cognitive impairment in this group of population;

4. The association between cognitive impairment and all-cause mortality, stroke and non-fatal cardiovascular events;

We hypothesize that hemodialysis patient is going to have cognitive impairment which might be associated with some risk factors. We also anticipate that cognitive impairment might have some kind of association with the clinical outcomes like all-cause mortality, stroke and other common clinical outcomes that we mentioned above.

Description:

Neuropsychological assessment All neuropsychological assessments were performed by the research staff that was centrally trained and certified by the study neuropsychologist to conduct the assessments before study commencement. All research staff and patients were native Chinese speakers. Neuropsychological assessment was conducted individually in a separate room on the day after a dialysis session and required on average approximately 90 minutes. Global cognitive function was screened by the Chinese Beijing version of the Montreal Cognitive Assessment (MoCA-BJ).10 The comprehensive battery of neuropsychological tests was designed to assess five cognitive domains: (1) attention/processing speed, using Symbol Digit Modalities Test and the Chinese modified version of the Trail Making Test A,11,12(2) executive function, using the Chinese modified version of the Trail Making Tests B , and a modified version of the Stroop Color-Word Test;13 (3) verbal memory, using the Chinese version of the Auditory Verbal Learning Test for short-delay and long-delay free recall14 and Complex Figure for visual memory (delayed recall test; Chinese version);12 (4) language, using the Chinese modified versions of Boston Naming Test (the 30-item version) and Animal Fluency Test;15,16and (5) visuospatial function, using the Rey-Osterrieth Complex Figure (copy test).17,18 Depression was assessed using the Hamilton Depression Scale, with scores ranging from 0 to 63 and a score of 7 or above suggested as the optimal cutoff for suspected depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: June 18, 2019
• Est. primary completion date: June 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subjects have end-stage kidney disease and are treated with long-term outpatient haemodialysis in each investigational site for at least the previous 3 months;

2. 50 ~ 80 years old;

3. willing to provide written and informed consent.

Exclusion Criteria:

1. Subjects have disturbance of consciousness or mental disorder;

2. Subjects have sensory (visual and hearing) or motor impairment, which disabled them to complete the tests that required these senses;

3. Subjects have a life expectancy less than 6 months according to their physician, have a planned kidney transplantation within 6 months of baseline, or have anticipated recovery of kidney function.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Hemodialysis Complication
• Neuropsychological Tests
• Outcome

Intervention

Other:
• cognitive impairment
one are of patients were exposed to cognitive impairment

Locations

Country	Name	City	State
China	Beijing Shijitan Hospital affiliated to Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Shijitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive function	This study is going to apply neuropsychological battery tests to measure cognitive function across multiple cognitive domains	This measurement is going to be completed within 3 months after the first participant enrolls.