Emotion and Cognitive Function and Brain Imaging Change in HD Patients

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05137470

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Chronic Cognitive Dysfunction Magnetic Resonance Imaging	Other: This is an observational study

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Appears obvious emotional and cognitive decline, or abnormal head MRI [2 years]
Appears obvious emotional and cognitive decline, or abnormal head MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing	China	100050

Sponsors and Collaborators

Beijing Friendship Hospital

Investigators

Study Director: WENHU LIU, doctor, Beijing Friendship Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beijing Friendship Hospital

ClinicalTrials.gov Identifier:

NCT05137470

Other Study ID Numbers:

YYYXYJ-2021-275

First Posted:

Nov 30, 2021

Last Update Posted:

Nov 30, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Renal Insufficiency

Kidney Failure, Chronic

Cognitive Dysfunction

Study Results

No Results Posted as of Nov 30, 2021