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

NCT05555836 | Unknown

• 1 other identifier: CFH2022-2-2081
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; Cerebral Blood Flow; Cognitive Function; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Changes in cognitive function which is measured by MoCA scores changes after 1 year follow-up

  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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese Maintenace Hemodialysis Patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Shijitan Hospital, Capital Medical University: lead

Study Sites (1)

Beijing Shijitan Hospital affiliated to Capital Medical University

Beijing, 100038, China

Location

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of nephrology Affiliation

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: September 27, 2022
• Study Start: January 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

CN (1)