NCT05137470

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 30, 2021

Status Verified

October 1, 2021

Enrollment Period

4.3 years

First QC Date

November 24, 2021

Last Update Submit

November 24, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Appears obvious emotional and cognitive decline, or abnormal head MRI

    Appears obvious emotional and cognitive decline, or abnormal head MRI

    2 years

Study Arms (2)

Newly HD patients

Newly admitted patients with uremia who started hemodialysis treatment

Other: This is an observational study

MHD patients

Maintenance hemodialysis patients

Other: This is an observational study

Interventions

This is an observational study

MHD patientsNewly HD patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Kidney Failure, ChronicCognitive Dysfunction

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • WENHU LIU, doctor

    Beijing Friendship Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2021

First Posted

November 30, 2021

Study Start

October 1, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

November 30, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations