NCT04433455

Brief Summary

In this observational study, the investigators evaluate the influencing factors of cerebrovascular disease and cognition in hemodialysis patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
3mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress96%
Jun 2020Dec 2026

First Submitted

Initial submission to the registry

May 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 23, 2026

Status Verified

September 1, 2025

Enrollment Period

6.6 years

First QC Date

May 19, 2020

Last Update Submit

September 20, 2026

Conditions

HemodialysisCognitive ImpairmentCerebrovascular Disorders

Outcome Measures

Primary Outcomes (1)

  • cerebrovascular disease

    Magnetic resonance images will be used to determine the severity of white matter hyperintensity, using the Scheltens scale. Score 2 or more is abnormal.

    5 years

Secondary Outcomes (1)

  • changes in cognitive function

    5 years

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

maintenance hemodialysis patients

You may qualify if:

  • maintenance hemodialysis patients who are younger than 85 years old and older than 50 years old, regardless of gender
  • dialysis vintage is greater than 3 months;

You may not qualify if:

  • Those with severe infection and anemia (Hb \<60g / L);
  • Those with severe mental illness, metabolic diseases and immune system diseases;
  • Patients with abnormal liver function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jing Chen

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Chen

CONTACT

862152889325chenjing1998@fudan.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2020

First Posted

June 16, 2020

Study Start

June 1, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 23, 2026

Record last verified: 2025-09

Locations

CN(1)