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

September 22, 2022 updated by: Yang Luo, Chief, MD, PhD, Beijing Shijitan Hospital, Capital Medical University

A Prospective Observational Study of the Association Between Cerebral Blood Flow Change and Cognitive Function in Older Maintenance Hemodialysis Patients

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Anticipated)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100038
        • Beijing Shijitan Hospital Affiliated to Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chinese Maintenace Hemodialysis Patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cognitive function which is measured by MoCA scores changes after 1 year follow-up
Time Frame: 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.
This measurement is going to be completed within 1 year after the last participant enrolls

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Shijitan Hospital, Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

September 30, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

September 17, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 22, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CFH2022-2-2081

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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