Dietary Sodium IntakeNCT05955417
A Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis.
An observational study of Dietary Sodium Intake and Peritoneal Dialysis (PD), run by Peking University First Hospital at 1 site in China.
Trial summary
This study aims to develop a novel equation for estimating sodium intake in anuric peritoneal dialysis patients, and then to validate its precision and accuracy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dietary Sodium Intake, Peritoneal Dialysis (PD)
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 20 Jan 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Peritoneal Dialysis Patients
Who may be able to join
- Peritoneal dialysis vintage >3 months.
- 18-80 years old.
- No residual renal function (urine volume<200ml/day).
Who cannot join
- Peritonitis in the past month.
- Acute systemic infection, cardio-cerebrovascular complications and surgical trauma in the past month.
- Uncorrected hyponatremia (blood sodium<130mmol/L).
- Prescribed with sodium bicarbonate.
- Prescribed with glucocorticoids and aldosterone antagonists.
- Dysfunction of peritoneal dialysis catheter.
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- Malignant tumor receiving radiotherapy and chemotherapy, severe dyspepsia or eating disorder.
- Body fluid loss due to vomit, diarrhea, massive sweating, or other causes.
- Cannot follow the research scheme.
- Refuse to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development and Validation of a Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis
This study aims to develop a novel equation for estimating sodium intake in anuric peritoneal dialysis patients, and then to validate its precision and accuracy.
Read the detailed description
Dietary sodium intake is closely associated with the prognosis of chronic kidney disease (CKD) patients. Previous studies have developed an equation for estimating dietary sodium intake through 24-hour urine sodium in CKD, which are not applicable in peritoneal dialysis patients. This study aims to develop a novel equation for estimating dietary sodium intake in 20 anuric peritoneal dialysis patients, using accurately measured dietary sodium as the dependent variable and peritoneal sodium removal and its related variables as independent variables, and then to validate the precision and accuracy of the novel equation in another 10 anuric peritoneal dialysis patients.
- Conditions
- Dietary Sodium Intake, Peritoneal Dialysis (PD)
- Keywords
- Dietary Sodium Intake, Peritoneal Dialysis, Equation
What is being measured
The primary outcome is the main question the study is designed to answer.
determination coefficient of the novel equation
Determination coefficient will be assessed as the square of the multiple correlation coefficient of the novel equation for estimating sodium intake in peritoneal dialysis.
Measured: July 3, 2023, to March 1, 2024
bias of the novel equation
Bias will be assessed as the median of the difference between the estimated and measured dietary sodium values.
Measured: July 3, 2023, to March 1, 2024
precision of the novel equation
Precision will be assessed as the standard deviation (SD) for the absolute value of difference between the estimated and measured dietary sodium values.
Measured: July 3, 2023, to March 1, 2024
accuracy of the novel equation
Accuracy will be assessed as the percentage of estimates that differed >20% from the measured dietary sodium values (1-P20) .
Measured: July 3, 2023, to March 1, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Aug 2023
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary Sodium IntakeStudies of the same condition, open and under way.
- More trials run by Peking University First 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
- Investigators
- Jie Dong, Professor, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955417
- Sponsor's protocol ID
- 2022SF38
- Status last verified
- Jun 2026
- First submitted
- 13 Jul 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Validation of a Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT05955417
- Acronym / sponsor ID
- 2022SF38
- Conditions
- Dietary Sodium Intake, Peritoneal Dialysis (PD)
- Keywords
- Dietary Sodium Intake, Peritoneal Dialysis, Equation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 21 Jul 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.
This study aims to develop a novel equation for estimating sodium intake in anuric peritoneal dialysis patients, and then to validate its precision and accuracy.
Detailed description
Dietary sodium intake is closely associated with the prognosis of chronic kidney disease (CKD) patients. Previous studies have developed an equation for estimating dietary sodium intake through 24-hour urine sodium in CKD, which are not applicable in peritoneal dialysis patients. This study aims to develop a novel equation for estimating dietary sodium intake in 20 anuric peritoneal dialysis patients, using accurately measured dietary sodium as the dependent variable and peritoneal sodium removal and its related variables as independent variables, and then to validate the precision and accuracy of the novel equation in another 10 anuric peritoneal dialysis patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Peritoneal Dialysis Patients
Key inclusion criteria (3 listed)
- Peritoneal dialysis vintage >3 months.
- 18-80 years old.
- No residual renal function (urine volume<200ml/day).
Key exclusion criteria (10 listed)
- Peritonitis in the past month.
- Acute systemic infection, cardio-cerebrovascular complications and surgical trauma in the past month.
- Uncorrected hyponatremia (blood sodium<130mmol/L).
- Prescribed with sodium bicarbonate.
- Prescribed with glucocorticoids and aldosterone antagonists.
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
determination coefficient of the novel equation
Time frame: July 3, 2023, to March 1, 2024
Determination coefficient will be assessed as the square of the multiple correlation coefficient of the novel equation for estimating sodium intake in peritoneal dialysis.
bias of the novel equation
Time frame: July 3, 2023, to March 1, 2024
Bias will be assessed as the median of the difference between the estimated and measured dietary sodium values.
precision of the novel equation
Time frame: July 3, 2023, to March 1, 2024
Precision will be assessed as the standard deviation (SD) for the absolute value of difference between the estimated and measured dietary sodium values.
accuracy of the novel equation
Time frame: July 3, 2023, to March 1, 2024
Accuracy will be assessed as the percentage of estimates that differed >20% from the measured dietary sodium values (1-P20) .
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 Jun 2026.
- 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.
Jie Dong, Professor principal investigator
Peking University First 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 Dietary Sodium Intake and Peritoneal Dialysis (PD), run by Peking University First 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 3 inclusion and 10 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 Jun 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?
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?
determination coefficient of the novel equation (time frame: July 3, 2023, to March 1, 2024). The study lists 4 primary outcomes in all. 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 Jun 2026.