Association Between Cerebral Blood Flow Change and Cognitive Function in Hemodialysis Patients

Sponsor
Beijing Shijitan Hospital, Capital Medical University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05555836
Collaborator
(none)
121
1
36
3.4

Study Details

Study Description

Brief Summary

The prevalence of cognitive impairment in maintenance hemodialysis (MHD) patients is 3 to 5 times higher than that in ordinary people, so it is essential to find the associated risk factors in this population. This project intends to evaluate whether changes in cerebral blood flow during dialysis have an impact on cognitive function in middle-aged and elderly MHD patients and clarify their influence on brain imaging characteristics. MHD patients who started hemodialysis at 3 to 6 months were selected to examine the difference in middle cerebral artery flow rate before and after dialysis by transcranial Doppler ultrasound to reflect the changes in cerebral blood flow. Changes in the cognitive function scale assessment (memory, executive function, and other five cognitive domains) and brain magnetic resonance imaging examinations are planned to collect both at baseline and after a one-year follow-up. Then the investigator used the multiple linear regression method to analyze the effects of the difference in middle cerebral artery flow on the changes in cognitive function and the characteristics in brain imaging. The investigators anticipate that the characteristics of the influence of changes in cerebral blood flow on cognitive impairment in Chinese MHD patients will be elucidated in this study, which may provide crucial clinical evidence for finding preventive and intervention measures for cognitive impairment in this group of population.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    121 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Observational Study of the Association Between Cerebral Blood Flow Change and Cognitive Function in Older Maintenance Hemodialysis Patients
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Sep 30, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Changes in cognitive function which is measured by MoCA scores changes after 1 year follow-up [This measurement is going to be completed within 1 year after the last participant enrolls]

      This study is going to apply neuropsychological battery tests in MoCA assessment and evaluate the changes of MoCA scores of MHD patients after one year of follow-up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Age greater than 50, no gender limitation;

    • End-stage renal disease, stable dialysis for 3-6 months;

    • Subjects voluntarily participated in the study and signed informed consent, and were able to participate in clinical data collection, neuropsychological assessment, transcranial Doppler ultrasound (TCD), head MRI, and 1-year follow-up.

    Exclusion Criteria:
    • Congenital mental retardation or disturbance of consciousness, schizophrenia, or history of severe anxiety and depression (Hamilton Depression Scale score more than 17;

    • Long-term alcohol or psychotropic drug dependence;

    • Those who cannot complete the neuropsychological assessment due to visual impairment, hearing impairment, or limb dysfunction; less than 10 hours of dialysis per week;

    • Patients with poor detection of the bilateral temporal window by TCD examination and unable to cooperate with ultrasound examination;

    • Those who cannot undergo head MRI examination for various reasons.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Shijitan Hospital affiliated to Capital Medical University Beijing China 100038

    Sponsors and Collaborators

    • Beijing Shijitan Hospital, Capital Medical University

    Investigators

    • Principal Investigator: Yang Luo, MD, PhD, Beijing Shijitan Hospital Affiliated to Capital Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yang Luo, Chief, MD, PhD, Director of nephrology Affiliation, Beijing Shijitan Hospital, Capital Medical University
    ClinicalTrials.gov Identifier:
    NCT05555836
    Other Study ID Numbers:
    • CFH2022-2-2081
    First Posted:
    Sep 27, 2022
    Last Update Posted:
    Sep 27, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 27, 2022