The Cohort Study of Cognitive Impairment in Chinese Hemodialysis Patients

NCT03251573 | Completed

• 1 other identifier: Z161100002616005
• Study Type: observational
• Target: 613
• Locations: 1 country
• Sites: 1

Brief 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. 1.The presence and patterns of cognitive impairment in domains of executive function, perceptual-motor function, language, learning and memory, and complex attention;
2. 2.Clinical characteristics of participants with and without cognitive impairment;
3. 3.the risk factors which might be related to cognitive impairment in this group of population;
4. 4.The association between cognitive impairment and all-cause mortality, stroke and non-fatal cardiovascular events;

Conditions

Cognitive Impairment; Hemodialysis Complication; Outcome; Neuropsychological Tests

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Normal cognitive function

The cognitive impairment classification algorithm We classified subjects as having no, mild, or major cognitive impairment using criteria from the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a guideline.20 The age and/or education-adjusted raw score of each individual cognitive test was calculated and compared with the age and/or education-adjusted published norms for Chinese populations.14 Specifically, age- and education-adjusted scores less than 1.5 standard deviations (SDs) below the adjusted mean of the published population norms on all tests in all domains indicated no cognitive impairment; scores of 1.50 to 1.99 SDs and 2.0 or more SDs below the adjusted mean of the published norms on at least one test in at least one domain indicated mild cognitive impairment and major cognitive impairment, respectively

cognitive impairment

The cognitive impairment classification algorithm We classified subjects as having no, mild, or major cognitive impairment using criteria from the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a guideline.20 The age and/or education-adjusted raw score of each individual cognitive test was calculated and compared with the age and/or education-adjusted published norms for Chinese populations.14 Specifically, age- and education-adjusted scores less than 1.5 standard deviations (SDs) below the adjusted mean of the published population norms on all tests in all domains indicated no cognitive impairment; scores of 1.50 to 1.99 SDs and 2.0 or more SDs below the adjusted mean of the published norms on at least one test in at least one domain indicated mild cognitive impairment and major cognitive impairment, respectively

Other: cognitive impairment

Interventions

cognitive impairment OTHER

one are of patients were exposed to cognitive impairment

cognitive impairment

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese Maintenace Hemodialysis Patients

You may qualify if:

• 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;
• \~ 80 years old;
• willing to provide written and informed consent.

You may not qualify if:

• Subjects have disturbance of consciousness or mental disorder;
• Subjects have sensory (visual and hearing) or motor impairment, which disabled them to complete the tests that required these senses;
• 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.

Sponsors & Collaborators

• Beijing Shijitan Hospital, Capital Medical University: lead

Study Sites (1)

Beijing Shijitan Hospital affiliated to Capital Medical University

Beijing, 100038, China

Location

Related Publications (1)

• Tian R, Bai Y, Guo Y, Ye P, Luo Y. Association Between Sleep Disorders and Cognitive Impairment in Middle Age and Older Adult Hemodialysis Patients: A Cross-Sectional Study. Front Aging Neurosci. 2021 Dec 8;13:757453. doi: 10.3389/fnagi.2021.757453. eCollection 2021.

  PMID: 34955811 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yang Luo, MD, PhD

  Beijing Shijitan Hospital Affiliated to Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of nephrology

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 16, 2017
• Study Start: September 1, 2017
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: July 12, 2019

Record last verified: 2019-07

Locations

CN (1)