HyperkalemiaNCT05860491
Dietary Fiber and Hyperkalemia in Dialysis Patients
An observational study of Hyperkalemia and Hemolysis, run by Qianfoshan Hospital at 1 site in China.
Trial summary
To analyze the dietary nutrition and dietary fiber (DF) intake of maintenance hemodialysis (MHD) patients, and explore the effect of dietary nutrition and DF intake balance on the nutritional status and pre-dialysis hyperkalemia of MHD patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperkalemia, Hemolysis
- What is being tested?
- dietary fiber
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Jun 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing hemodialysis
Who may be able to join
- 18-65 years old; undergoing hemodialysis at least 3months; with a certain level of education; with complete behavioral ability
Who cannot join
- In the acute phase of acute cardiovascular disease, acute cerebrovascular disease, and acute digestive system disease；Anorexia, long-term malnutrition, or dietary disorders；poor compliance；
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Dietary Fiber on Hyperkalemia in Hemodialysis Patients
To analyze the dietary nutrition and dietary fiber (DF) intake of maintenance hemodialysis (MHD) patients, and explore the effect of dietary nutrition and DF intake balance on the nutritional status and pre-dialysis hyperkalemia of MHD patients.
Read the detailed description
A total of 100 MHD patients were retrospectively enrolled, including 67 males and 33 females. The daily diet was recorded by 3-day dietary recording method. The daily average dietary nutritional intake and DF intake of MHD patients were calculated by professional software. Dietary guidance and analysis were conducted according to the Expert Consensus on Nutrition in Chronic Kidney Disease (2005) and the Dietary Guidelines for Chinese Residents (2016). Of the 100 patients, 37 had hyperkalemia (serum potassium > 5.5 mmol/L) before dialysis.
- Conditions
- Hyperkalemia, Hemolysis
- Being tested
- dietary fiber
- Medical subject headings
- Hyperkalemia, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary fiberOther
Retrospective analysis of the relationship between patient dietary fiber intake and hyperkalemia
| Study group | Role | What they receive |
|---|---|---|
| patients with pre-dialysis hyperkalemia | To investigate the dietary fiber intake of hemodialysis patients with pre-dialysis hyperkalemia. Use a retrospective analysis method. Analyze the relationship between dietary fiber intake and hyperkalemia. Receives: Other: dietary fiber | |
| patients without pre-dialysis hyperkalemia | To investigate the dietary fiber intake of hemodialysis patients without pre-dialysis hyperkalemia. Use a retrospective analysis method. Analyze the relationship between dietary fiber intake and hyperkalemia. Receives: Other: dietary fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary fiber intake
Dietary fiber intake
Measured: 3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Li, Qianfoshan Hospital
- Investigators
- Yang Li, Master, Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860491
- Sponsor's protocol ID
- DF-hyperkalemia
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dietary Fiber on Hyperkalemia in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05860491
- Acronym / sponsor ID
- DF-hyperkalemia
- Conditions
- Hyperkalemia, Hemolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 May 2023 (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.
To analyze the dietary nutrition and dietary fiber (DF) intake of maintenance hemodialysis (MHD) patients, and explore the effect of dietary nutrition and DF intake balance on the nutritional status and pre-dialysis hyperkalemia of MHD patients.
Detailed description
A total of 100 MHD patients were retrospectively enrolled, including 67 males and 33 females. The daily diet was recorded by 3-day dietary recording method. The daily average dietary nutritional intake and DF intake of MHD patients were calculated by professional software. Dietary guidance and analysis were conducted according to the Expert Consensus on Nutrition in Chronic Kidney Disease (2005) and the Dietary Guidelines for Chinese Residents (2016). Of the 100 patients, 37 had hyperkalemia (serum potassium > 5.5 mmol/L) before dialysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with pre-dialysis hyperkalemia | – | Other: dietary fiberTo investigate the dietary fiber intake of hemodialysis patients with pre-dialysis hyperkalemia. Use a retrospective analysis method. Analyze the relationship between dietary fiber intake and hyperkalemia. |
| patients without pre-dialysis hyperkalemia | – | Other: dietary fiberTo investigate the dietary fiber intake of hemodialysis patients without pre-dialysis hyperkalemia. Use a retrospective analysis method. Analyze the relationship between dietary fiber intake and hyperkalemia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing hemodialysis
Key inclusion criteria (1 listed)
- 18-65 years old; undergoing hemodialysis at least 3months; with a certain level of education; with complete behavioral ability
Key exclusion criteria (1 listed)
- In the acute phase of acute cardiovascular disease, acute cerebrovascular disease, and acute digestive system disease；Anorexia, long-term malnutrition, or dietary disorders；poor compliance；
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 |
|---|---|---|
| dietary fiberRetrospective analysis of the relationship between patient dietary fiber intake and hyperkalemia | Other | patients with pre-dialysis hyperkalemia, patients without pre-dialysis hyperkalemia |
Primary outcome
Dietary fiber intake
Time frame: 3 day
Dietary fiber intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Yang Li, Master principal investigator
Qianfoshan 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 Hyperkalemia and Hemolysis, run by Qianfoshan 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary fiber intake (time frame: 3 day). 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 16 May 2023.