HemodialysisNCT04433455
Influencing Factors of Cerebrovascular Disease and Cognition in Hemodialysis Patients
An observational study of Hemodialysis and Cognitive Impairment, run by Huashan Hospital at 1 site in China.
Trial summary
In this observational study, the investigators evaluate the influencing factors of cerebrovascular disease and cognition in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Hemodialysis, Cognitive Impairment, Cerebrovascular Disorders
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: maintenance hemodialysis patients
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Qian Zhang
About this study
Official title: Influencing Factors of Cerebrovascular Disease and Cognition in Hemodialysis Patients: an Observational Study
In this observational study, the investigators evaluate the influencing factors of cerebrovascular disease and cognition in hemodialysis patients.
- Medical subject headings
- Cognitive Dysfunction, Cerebrovascular Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
changes in cognitive function
The Mini-Mental State Examination (MMSE) will be used to assess the changes in cognitive function.The MMSE has a maximum score of 30 points. The scores are generally grouped as follows:
25-30 points: normal cognition 21-24 points: mild dementia 10-20 points: moderate dementia 9 points or lower: severe dementiaThe Mini-Mental State Examination (MMSE) will be used to assess the changes in cognitive function.The MMSE has a maximum score of 30 points. The scores are generally grouped as follows: 25-30 points: normal cognition 21-24 points: mild dementia 10-20 points: moderate dementia 9 points or lower: severe dementia
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Jing, Huashan Hospital
- Investigators
- Jing Chen, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433455
- Sponsor's protocol ID
- KY2019-465
- Status last verified
- Sep 2025
- First submitted
- 19 May 2020
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Factors of Cerebrovascular Disease and Cognition in Hemodialysis Patients: an Observational Study
- ClinicalTrials.gov ID
- NCT04433455
- Acronym / sponsor ID
- KY2019-465
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this observational study, the investigators evaluate the influencing factors of cerebrovascular disease and cognition in hemodialysis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- maintenance hemodialysis patients
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cerebrovascular disease
Time frame: 5 years
Magnetic resonance images will be used to determine the severity of white matter hyperintensity, using the Scheltens scale. Score 2 or more is abnormal.
1 secondary outcome
changes in cognitive function
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Chen principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis and Cognitive Impairment, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Chen (862152889325, chenjing1998@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebrovascular disease (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.