Emotion and Cognitive Function and Brain Imaging Change in HD Patients

November 24, 2021 updated by: Beijing Friendship Hospital

Study on the Changes of Emotion and Cognitive Function and Brain Imaging in Uremic Patients Before and After Entering Dialysis

  1. Observe the influence of entering hemodialysis treatment on the emotional and cognitive functions of ESRD patients.
  2. Observe the influence of entering hemodialysis treatment on the brain structure imaging of ESRD patients.
  3. Analyze and study the relevant clinical risk factors of the above-mentioned effects, and find targets for therapeutic intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Select uremic patients and maintenance hemodialysis patients admitted to the Central Dialysis Room of Beijing Friendship Hospital, Capital Medical University from 2021, to collect and sort out the demographic characteristics of the patients: gender, age, clinical characteristics: primary disease, complications and Complications, body mass index (BMI), residual renal function, etc., clinical examination indicators: hemoglobin, blood calcium, blood phosphorus, blood PTH, blood albumin, URR, etc., hemodialysis treatment parameters: dialysis mode, dialyzer model, vascular access , Blood flow, etc., record the patient's emotional and cognitive function status, various clinical indicators and changes in the patient's quality of life before and after the start of treatment, and use multimodal magnetic resonance neuroimaging research sequences to analyze the changes in the patient's brain structure and function.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Uremia patients undergoing hemodialysis treatment in the hemodialysis room of Beijing Friendship Hospital

Description

Inclusion Criteria:

  • Patients who are new to hemodialysis treatment, and those who are on regular hemodialysis treatment for ≥6 months.
  • Age ≥ 18 years old.

Exclusion Criteria:

  • There was already a severe central nervous system disease before dialysis.
  • Hearing and visual impairment cannot communicate or cooperate.
  • Mental illness and incapacity.
  • The magnetic resonance examination could not be completed for various reasons.
  • Life expectancy with serious diseases is less than 6 months.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Newly HD patients
Newly admitted patients with uremia who started hemodialysis treatment
Other: This is an observational study
This is an observational study
MHD patients
Maintenance hemodialysis patients
Other: This is an observational study
This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appears obvious emotional and cognitive decline, or abnormal head MRI
Time Frame: 2 years
Appears obvious emotional and cognitive decline, or abnormal head MRI
2 years

Collaborators and Investigators

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

Sponsor

Beijing Friendship Hospital

Investigators

  • Study Director: WENHU LIU, doctor, Beijing Friendship Hospital

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)

October 1, 2021

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

November 24, 2021

First Posted (Actual)

November 30, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YYYXYJ-2021-275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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