Emotion and Cognitive Function and Brain Imaging Change in HD Patients

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05137470
• Other study ID #: YYYXYJ-2021-275
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2021
• Source: Beijing Friendship Hospital
• Contact: XU LIU, master
• Phone: +86-010-63138579
• Email: liuxu_000[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Kidney Failure, Chronic
• Magnetic Resonance Imaging
• Renal Insufficiency

Intervention

Other:
• This is an observational study
This is an observational study

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appears obvious emotional and cognitive decline, or abnormal head MRI	Appears obvious emotional and cognitive decline, or abnormal head MRI	2 years