Peritoneal DialysisNCT07659067
Predicting Peritoneal Kt/Vurea Based on Single-Exchange Dialysate Effluent
An observational study of Peritoneal Dialysis, run by Peking University First Hospital.
Trial summary
Background: Peritoneal dialysis (PD) adequacy is routinely evaluated using the urea clearance index (Kt/Vurea), a key indicator of small-solute clearance and treatment adequacy. The standard method for calculating peritoneal Kt/Vurea requires complete collection of 24-hour dialysate effluent, which is labor-intensive… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Peritoneal Dialysis
- What is being tested?
- Single-Exchange Dialysate Effluent-Based Prediction of Peritoneal Kt/Vurea
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2027
- 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 14 years and older
- All sexes
- Child, Adult, Older adult
Study population: The study will be conducted between 2026 and 2027 across four peritoneal dialysis (PD) centers in China. All prevalent patients receiving manual PD will be screened for eligibility.
Who may be able to join
- Patients aged ≥14 years who have been receiving PD for at least one month.
Who cannot join
- peritonitis or other acute complications (e.g., severe infection or acute heart failure) within 1 month prior to enrollment; (2) spontaneous ascites; (3) inability to complete full collection of all dialysate effluent during the study dialysis day; (4) refusal or inability to provide written informed consent.
About this study
Official title: Development and Validation of a Prediction Model for Peritoneal Kt/Vurea Using Single-Exchange Dialysate Effluent in Patients Undergoing Peritoneal Dialysis
Background:
Peritoneal dialysis (PD) adequacy is routinely evaluated using the urea clearance index (Kt/Vurea), a key indicator of small-solute clearance and treatment adequacy. The standard method for calculating peritoneal Kt/Vurea requires complete collection of 24-hour dialysate effluent, which is labor-intensive, time-consuming, and prone to errors arising from incomplete collection, inadequate mixing, and inaccurate sampling. Although proportional sampling from each exchange has been shown to yield results comparable to those obtained from complete 24-hour effluent collection, this approach still requires collection of all exchanges throughout the day. Previous studies have suggested that Kt/Vurea estimated from a single dialysate exchange may correlate with the standard measurement; however, these investigations were limited by small sample sizes and did not establish predictive equations. Therefore, a practical and accurate alternative for assessing peritoneal Kt/Vurea is still lacking.
Read more
Objective:
To develop and validate a prediction model for peritoneal Kt/Vurea based on single-exchange dialysate effluent in patients undergoing PD.
Methods:
This multicenter cross-sectional study will be conducted between 2026 and 2027 across four PD centers in China. Consecutive prevalent patients receiving manual PD will be screened for eligibility. Patients aged ≥14 years who have been receiving PD for at least one month will be included. Exclusion criteria comprise peritonitis or other acute complications within the preceding month, spontaneous ascites, inability to complete full dialysate collection during the study day, and refusal to provide informed consent. Demographic characteristics, primary kidney disease, comorbidities, and PD prescription parameters will be collected. On a designated study day, effluent from each dialysis exchange, 24-hour urine samples, and fasting blood samples will be obtained. The correlations between peritoneal Kt/Vurea calculated from individual exchanges and the reference peritoneal Kt/Vurea derived from complete 24-hour dialysate collection will be evaluated. Multivariable prediction models incorporating single-exchange effluent measurements and relevant clinical parameters will subsequently be developed and validated. Model performance will be assessed using measures of discrimination, calibration, and agreement with reference Kt/Vurea values.
Conclusions:
This study aims to establish and validate a simplified method for estimating peritoneal Kt/Vurea using single-exchange dialysate effluent. If validated, the proposed model may substantially reduce the burden associated with 24-hour dialysate collection while maintaining adequate accuracy for routine assessment of PD adequacy.
Read the detailed description
This is a multicenter cross-sectional study aimed at developing and externally validating a prediction model for estimating peritoneal Kt/Vurea using single-exchange dialysate effluent in patients undergoing peritoneal dialysis.
- Conditions
- Peritoneal Dialysis
- Being tested
- Single-Exchange Dialysate Effluent-Based Prediction of Peritoneal Kt/Vurea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Exchange Dialysate Effluent-Based Prediction of Peritoneal Kt/VureaDiagnostic test
Peritoneal Kt/Vurea will be estimated using measurements obtained from a single exchange of dialysate effluent and compared with the reference peritoneal Kt/Vurea derived from complete 24-hour dialysate collection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of prediction of peritoneal Kt/Vurea using single-exchange dialysate effluent
Measured: Baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659067
- Sponsor's protocol ID
- Peritoneal Kt/Vurea
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Prediction Model for Peritoneal Kt/Vurea Using Single-Exchange Dialysate Effluent in Patients Undergoing Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT07659067
- Acronym / sponsor ID
- Peritoneal Kt/Vurea
- Conditions
- Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Jun 2026 (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.
Background:
Peritoneal dialysis (PD) adequacy is routinely evaluated using the urea clearance index (Kt/Vurea), a key indicator of small-solute clearance and treatment adequacy. The standard method for calculating peritoneal Kt/Vurea requires complete collection of 24-hour dialysate effluent, which is labor-intensive, time-consuming, and prone to errors arising from incomplete collection, inadequate mixing, and inaccurate sampling. Although proportional sampling from each exchange has been shown to yield results comparable to those obtained from complete 24-hour effluent collection, this approach still requires collection of all exchanges throughout the day. Previous studies have suggested that Kt/Vurea estimated from a single dialysate exchange may correlate with the standard measurement; however, these investigations were limited by small sample sizes and did not establish predictive equations. Therefore, a practical and accurate alternative for assessing peritoneal Kt/Vurea is still lacking.
Objective:
To develop and validate a prediction model for peritoneal Kt/Vurea based on single-exchange dialysate effluent in patients undergoing PD.
Methods:
This multicenter cross-sectional study will be conducted between 2026 and 2027 across four PD centers in China. Consecutive prevalent patients receiving manual PD will be screened for eligibility. Patients aged ≥14 years who have been receiving PD for at least one month will be included. Exclusion criteria comprise peritonitis or other acute complications within the preceding month, spontaneous ascites, inability to complete full dialysate collection during the study day, and refusal to provide informed consent. Demographic characteristics, primary kidney disease, comorbidities, and PD prescription parameters will be collected. On a designated study day, effluent from each dialysis exchange, 24-hour urine samples, and fasting blood samples will be obtained. The correlations between peritoneal Kt/Vurea calculated from individual exchanges and the reference peritoneal Kt/Vurea derived from complete 24-hour dialysate collection will be evaluated. Multivariable prediction models incorporating single-exchange effluent measurements and relevant clinical parameters will subsequently be developed and validated. Model performance will be assessed using measures of discrimination, calibration, and agreement with reference Kt/Vurea values.
Conclusions:
This study aims to establish and validate a simplified method for estimating peritoneal Kt/Vurea using single-exchange dialysate effluent. If validated, the proposed model may substantially reduce the burden associated with 24-hour dialysate collection while maintaining adequate accuracy for routine assessment of PD adequacy.
Detailed description
This is a multicenter cross-sectional study aimed at developing and externally validating a prediction model for estimating peritoneal Kt/Vurea using single-exchange dialysate effluent in patients undergoing peritoneal dialysis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted between 2026 and 2027 across four peritoneal dialysis (PD) centers in China. All prevalent patients receiving manual PD will be screened for eligibility.
Key inclusion criteria (1 listed)
- Patients aged ≥14 years who have been receiving PD for at least one month.
Key exclusion criteria (1 listed)
- peritonitis or other acute complications (e.g., severe infection or acute heart failure) within 1 month prior to enrollment; (2) spontaneous ascites; (3) inability to complete full collection of all dialysate effluent during the study dialysis day; (4) refusal or inability to provide written informed consent.
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 |
|---|---|---|
| Single-Exchange Dialysate Effluent-Based Prediction of Peritoneal Kt/VureaPeritoneal Kt/Vurea will be estimated using measurements obtained from a single exchange of dialysate effluent and compared with the reference peritoneal Kt/Vurea derived from complete 24-hour dialysate collection. | Diagnostic test | – |
Primary outcome
Accuracy of prediction of peritoneal Kt/Vurea using single-exchange dialysate effluent
Time frame: Baseline (single assessment)
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 22 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Dialysis, run by Peking University First Hospital.
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: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Accuracy of prediction of peritoneal Kt/Vurea using single-exchange dialysate effluent (time frame: Baseline (single assessment)). 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 22 Jun 2026.