Hemodialysis ComplicationVisualize-HDNCT05020717
Retrospective Survey of Hyperkalemia in Hemodialysis
An observational study of Hemodialysis Complication, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study aim to describe hyperkalemia clinical burden and investigate the risk factors associated with the burden on HD facility level. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemodialysis Complication
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Sep 2021to Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HD centers in China
Who may be able to join
- -
- For HD centers:
- ≥ 100 patients under MHD within 3 years prior the study initiation
- Willing to participate in the study
- Have routine blood collection after LIDI
- Have death records
- For HD patients:
- On chronic HD for ≥ 3 months
Who cannot join
- Blood test on other days than those after LIDI
- Unable to provide detailed data required by study protocol
- Being unable to comply with study-specified procedure
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Baoguo Jiang, +86(10)88324008, jiangbaoguo@vip.sina.com
Li Zuo, +86(10)88324008, zuoli@bjmu.edu.cn
About this study
Official title: A Multicenter Retrospective Survey of Hyperkalemia Clinical Burden on Hemodialysis Facility-level in China
This study aim to describe hyperkalemia clinical burden and investigate the risk factors associated with the burden on HD facility level.
Read the detailed description
This study is an observational survey study. We estimate 300 hemodialysis (HD) centres will be enrolled in the study. Summarized data on serum potassium (sK) after long interdialytic interval (LIDI), facility practice pattern and patient characteristics which may be related with sK management, and death records information including number of deaths for each centre will be collected. All the data collected and analysed are on HD facility level, not on patient-level. We are aiming to describe hyperkalemia clinical burden and investigate the risk factors associated with the burden on HD facility level. Association between sK management and long-term outcome will also be explored.
- Conditions
- Hemodialysis Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the risk factors associated with hyperkalemia clinical burden on HD facility level
Examine the association of risk factors at current status to hyperkalemia prevalence on HD facility level
Measured: 3 years
Secondary outcomes (3)
To describe hyperkalemia clinical burden on HD facility level
Constitution ratio of different sK levels after LIDI in ranges: (0, 3.5], (3.5, 5.0], (5.0, 5.5], (5.5, 6.0], (6.0, 6.5], (6.5, 7.0], (7.0~) mmol/L in HD centers
Measured: 3 years
To describe sK management pattern on HD facility level
Proportion of patients on 3 times/week, 5 times/2 weeks, 2 times/week, less than 2 times/week, and other frequencies of HD treatment Proportion of patients with dialysate potassium concentration at 2.0 mmol/L, 2.5 mmol/L, 3.0 mmol/L and others Proportion of patients with sK testing on monthly, once per 3 months, once per > 3 months and others
Measured: 3 years
To investigate the risk factors associated with crude mortality on HD facility level
Examine the association of risk factors back to 3 years ago to crude mortality on HD facility level, risk factors back to 3 years ago including:
Constitution ratio of different sK levels after LIDI in ranges: (0, 3.5], (3.5, 5.0], (5.0, 5.5], (5.5, 6.0], (6.0, 6.5], (6.5, 7.0], (7.0~) mmol/L in HD centers back to 3 years ago.
Constitution ratio of last sK levels before death in ranges: (0, 3.5], (3.5, 5.0], (5.0, 5.5], (5.5, 6.0], (6.0, 6.5], (6.5, 7.0], (7.0~) mmol/L in HD centers Key sK management factors (dialysis frequency, dialysate potassium concentration, sK testing frequency) Other factors (length of dialysis/session, patients dialysis vintage, residual renal function, etiology of ESRD, comorbidities, medication use)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Li Zuo, Peking University People's Hospital
- Investigators
- Li Zuo, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020717
- Sponsor's protocol ID
- 20-20591
- Acronym
- Visualize-HD
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xinju Z, Changying X, Hong L, Guisen L, Ping Z, Caili W, Zuying X, Gang X, Rong W, Rongshan L, Aili J, Hongli J, Jianxin W, Xiaoling W, Jing Y, Li Y, Pei W, Rui Z, Yunhua L, Huimin L, Jinsheng X, Menghua C, Yinhui L, Qinkai C, Zhongfei Y, Yan Z, Hong L, Wenbo H, Chen L, Zhaohui N, Lingling G, Li Z. Prevalence, practice pattern, and mortality of hyperkalemia in Chinese patients undergoing hemodialysis in the visualize HD study. Sci Rep. 2025 Jul 1;15(1):22405. doi: 10.1038/s41598-025-92609-1.
PubMed 40596462Zhao X, Zuo L. Multicentre, observational, retrospective cohort of hyperkalaemia burden at haemodialysis facility-level in China: the Visualize-HD study protocol. BMJ Open. 2023 Sep 21;13(9):e066394. doi: 10.1136/bmjopen-2022-066394.
PubMed 37734899
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Retrospective Survey of Hyperkalemia Clinical Burden on Hemodialysis Facility-level in China
- ClinicalTrials.gov ID
- NCT05020717
- Acronym / sponsor ID
- Visualize-HD / 20-20591
- Conditions
- Hemodialysis Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Sep 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Aug 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.
This study aim to describe hyperkalemia clinical burden and investigate the risk factors associated with the burden on HD facility level.
Detailed description
This study is an observational survey study. We estimate 300 hemodialysis (HD) centres will be enrolled in the study. Summarized data on serum potassium (sK) after long interdialytic interval (LIDI), facility practice pattern and patient characteristics which may be related with sK management, and death records information including number of deaths for each centre will be collected. All the data collected and analysed are on HD facility level, not on patient-level. We are aiming to describe hyperkalemia clinical burden and investigate the risk factors associated with the burden on HD facility level. Association between sK management and long-term outcome will also be explored.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HD centers in China
Key inclusion criteria (8 listed)
- -
- ≥ 100 patients under MHD within 3 years prior the study initiation
- Willing to participate in the study
- Have routine blood collection after LIDI
- Have death records
Key exclusion criteria (3 listed)
- Blood test on other days than those after LIDI
- Unable to provide detailed data required by study protocol
- Being unable to comply with study-specified procedure
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
To investigate the risk factors associated with hyperkalemia clinical burden on HD facility level
Time frame: 3 years
Examine the association of risk factors at current status to hyperkalemia prevalence on HD facility level
3 secondary outcomes
To describe hyperkalemia clinical burden on HD facility level
Time frame: 3 years
To describe sK management pattern on HD facility level
Time frame: 3 years
To investigate the risk factors associated with crude mortality on HD facility level
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 40596462Xinju Z, Changying X, Hong L, Guisen L, Ping Z, Caili W, Zuying X, Gang X, Rong W, Rongshan L, Aili J, Hongli J, Jianxin W, Xiaoling W, Jing Y, Li Y, Pei W, Rui Z, Yunhua L, Huimin L, Jinsheng X, Menghua C, Yinhui L, Qinkai C, Zhongfei Y, Yan Z, Hong L, Wenbo H, Chen L, Zhaohui N, Lingling G, Li Z. Prevalence, practice pattern, and mortality of hyperkalemia in Chinese patients undergoing hemodialysis in the visualize HD study. Sci Rep. 2025 Jul 1;15(1):22405. doi: 10.1038/s41598-025-92609-1.
- Derived from this study: PubMed 37734899Zhao X, Zuo L. Multicentre, observational, retrospective cohort of hyperkalaemia burden at haemodialysis facility-level in China: the Visualize-HD study protocol. BMJ Open. 2023 Sep 21;13(9):e066394. doi: 10.1136/bmjopen-2022-066394.
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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.
Li Zuo principal investigator
Peking University People's 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 Complication, run by Peking University People's 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 8 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: status not confirmed, as of the sponsor's last update on 25 Aug 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 Li Zuo (+86(10)88324008, zuoli@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the risk factors associated with hyperkalemia clinical burden on HD facility level (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05020717, which also lists 2 linked publications.
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 25 Aug 2021.