Kidney Failure, ChronicNCT05137470
Emotion and Cognitive Function and Brain Imaging Change in HD Patients
An observational study of Kidney Failure, Chronic and Cognitive Dysfunction, run by Beijing Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Cognitive Dysfunction, Magnetic Resonance Imaging
- What is being tested?
- This is an observational study
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Uremia patients undergoing hemodialysis treatment in the hemodialysis room of Beijing Friendship Hospital
Who may be able to join
- Patients who are new to hemodialysis treatment, and those who are on regular hemodialysis treatment for ≥6 months.
- Age ≥ 18 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
XU LIU, master, +861063138579, liuxu_000@sina.com
About this study
Official title: Study on the Changes of Emotion and Cognitive Function and Brain Imaging in Uremic Patients Before and After Entering Dialysis
- 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.
Read the 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.
- Being tested
- This is an observational study
- Medical subject headings
- Kidney Failure, Chronic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational studyOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Newly HD patients | Newly admitted patients with uremia who started hemodialysis treatment Receives: Other: This is an observational study | |
| MHD patients | Maintenance hemodialysis patients Receives: Other: This is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appears obvious emotional and cognitive decline, or abnormal head MRI
Appears obvious emotional and cognitive decline, or abnormal head MRI
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- WENHU LIU, doctor, Study director, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137470
- Sponsor's protocol ID
- YYYXYJ-2021-275
- Status last verified
- Oct 2021
- First submitted
- 24 Nov 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Changes of Emotion and Cognitive Function and Brain Imaging in Uremic Patients Before and After Entering Dialysis
- ClinicalTrials.gov ID
- NCT05137470
- Acronym / sponsor ID
- YYYXYJ-2021-275
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Nov 2021 (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.
- 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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newly HD patients | – | Other: This is an observational studyNewly admitted patients with uremia who started hemodialysis treatment |
| MHD patients | – | Other: This is an observational studyMaintenance hemodialysis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Uremia patients undergoing hemodialysis treatment in the hemodialysis room of Beijing Friendship Hospital
Key inclusion criteria (2 listed)
- Patients who are new to hemodialysis treatment, and those who are on regular hemodialysis treatment for ≥6 months.
- Age ≥ 18 years old.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational studyThis is an observational study | Other | MHD patients, Newly HD patients |
Primary outcome
Appears obvious emotional and cognitive decline, or abnormal head MRI
Time frame: 2 years
Appears obvious emotional and cognitive decline, or abnormal head MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
WENHU LIU, doctor study director
Beijing Friendship 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 Kidney Failure, Chronic and Cognitive Dysfunction, run by Beijing Friendship 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 5 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: status not confirmed, as of the sponsor's last update on 30 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XU LIU, master (+86-010-63138579, liuxu_000@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appears obvious emotional and cognitive decline, or abnormal head MRI (time frame: 2 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 30 Nov 2021.