Dialysis Efficiency and Transporter Evaluation Computational Tool in Peritoneal Dialysis
NCT ID: NCT06842927
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
350 participants
OBSERVATIONAL
2025-03-03
2026-03-31
Brief Summary
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The main questions it aims to answer are:
Can artificial intelligence predict peritoneal transporter status based on simple clinical and biochemical measurements? Can artificial intelligence predict dialysis adequacy (Kt/V) using these features?
Researchers will compare the performance of the AI model with the gold standard Peritoneal Equilibration Test (PET) and Kt/V to evaluate its accuracy and reliability.
Participants will:
Provide peritoneal dialysate and spot urine samples for biochemical analysis. Undergo routine dialysis adequacy and peritoneal equilibration testing (PET). Have clinical and laboratory data collected for AI model training and validation.
The study will recruit approximately 350 peritoneal dialysis patients, with 280 participants in the training/validation arm and 70 participants in the test arm. The study duration is 12 months following enrollment.
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Detailed Description
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Patient recruitment and data collection will be conducted during routine dialysis adequacy and peritoneal transporter status assessments. The following clinical and biochemical parameters will be collected:
Demographics \& Medical History Peritoneal Dialysis Data Biochemical Data
The AI model will be developed using Python 3.11 and PyTorch 2.41 for deep learning and predictive analytics.
The key methodological steps include:
Data Preprocessing: Handling missing values, feature scaling, and one-hot encoding for categorical variables.
Feature Selection: Identifying the most predictive clinical and biochemical markers.
Model Training: Using deep learning regression models to predict PET and Kt/V outcomes.
Performance Evaluation: Evaluating model accuracy using:
Mean Absolute Error (MAE) Mean Squared Error (MSE) R² score (coefficient of determination) Bland-Altman plots and correlation coefficients for agreement with measured values.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Training/Validation
Participants in training/validation arm will receive the same standard investigations and care as part of their routine PD management, including clinical evaluations, biochemical testing, and measurements of peritoneal transporter status via the Peritoneal Equilibrium Test (PET) and dialysis adequacy (Kt/V).
data collection
An additional collection of peritoneal dialysate and spot urine samples will be collected.
Participants randomized to the training/validation arm will have their data used for model development, including the training and validation phases.
Test
Participants in training/validation arm will receive the same standard investigations and care as part of their routine PD management, including clinical evaluations, biochemical testing, and measurements of peritoneal transporter status via the Peritoneal Equilibrium Test (PET) and dialysis adequacy (Kt/V).
data report
An additional collection of peritoneal dialysate and spot urine samples will be collected. Participants randomized to the test arm will have their data isolated and reserved exclusively for evaluating the performance of the final AI model
Interventions
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data collection
An additional collection of peritoneal dialysate and spot urine samples will be collected.
Participants randomized to the training/validation arm will have their data used for model development, including the training and validation phases.
data report
An additional collection of peritoneal dialysate and spot urine samples will be collected. Participants randomized to the test arm will have their data isolated and reserved exclusively for evaluating the performance of the final AI model
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of end-stage renal failure requiring peritoneal dialysis as renal replacement therapy
* Ability to give informed consent and comply with study procedures.
Exclusion Criteria
* Ongoing PD peritonitis with or without antibiotic therapy
* Just finished PD peritonitis antibiotic treatment within recent 4 weeks
* Pregnancy
* Patient refusal
18 Years
ALL
No
Sponsors
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Tuen Mun Hospital
OTHER_GOV
Responsible Party
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Ka Chun Leung
Resident Specialist
Locations
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Tuen Mun Hospital
Tuenmen, , Hong Kong
Countries
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References
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Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract available.
Szeto CC, Wong TY, Chow KM, Leung CB, Li PK. Dialysis adequacy and transport test for characterization of peritoneal transport type in Chinese peritoneal dialysis patients receiving three daily exchanges. Am J Kidney Dis. 2002 Jun;39(6):1287-99. doi: 10.1053/ajkd.2002.33405.
SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.
Chen CA, Lin SH, Hsu YJ, Li YC, Wang YF, Chiu JS. Neural network modeling to stratify peritoneal membrane transporter in predialytic patients. Intern Med. 2006;45(9):663-4. doi: 10.2169/internalmedicine.45.1419. Epub 2006 Jun 1. No abstract available.
Gu J, Bai E, Ge C, Winograd J, Shah AD. Peritoneal equilibration testing: Your questions answered. Perit Dial Int. 2023 Sep;43(5):361-373. doi: 10.1177/08968608221133629. Epub 2022 Nov 9.
Morelle J, Stachowska-Pietka J, Oberg C, Gadola L, La Milia V, Yu Z, Lambie M, Mehrotra R, de Arteaga J, Davies S. ISPD recommendations for the evaluation of peritoneal membrane dysfunction in adults: Classification, measurement, interpretation and rationale for intervention. Perit Dial Int. 2021 Jul;41(4):352-372. doi: 10.1177/0896860820982218. Epub 2021 Feb 10.
Blake PG, Bargman JM, Brimble KS, Davison SN, Hirsch D, McCormick BB, Suri RS, Taylor P, Zalunardo N, Tonelli M; Canadian Society of Nephrology Work Group on Adequacy of Peritoneal Dialysis. Clinical Practice Guidelines and Recommendations on Peritoneal Dialysis Adequacy 2011. Perit Dial Int. 2011 Mar-Apr;31(2):218-39. doi: 10.3747/pdi.2011.00026. No abstract available.
Chen JB, Lam KK, Su YJ, Lee WC, Cheng BC, Kuo CC, Wu CH, Lin E, Wang YC, Chen TC, Liao SC. Relationship between Kt/V urea-based dialysis adequacy and nutritional status and their effect on the components of the quality of life in incident peritoneal dialysis patients. BMC Nephrol. 2012 Jun 14;13:39. doi: 10.1186/1471-2369-13-39.
Lin YL, Lee YC, Lee CC, Wu MH. Role of Peritoneal Equilibration Test in Assessing Folate Transport During Peritoneal Dialysis. J Ren Nutr. 2024 Sep;34(5):463-468. doi: 10.1053/j.jrn.2024.02.003. Epub 2024 Mar 13.
Cnossen TT, Smit W, Konings CJ, Kooman JP, Leunissen KM, Krediet RT. Quantification of free water transport during the peritoneal equilibration test. Perit Dial Int. 2009 Sep-Oct;29(5):523-7.
Twardowski ZJ. Clinical value of standardized equilibration tests in CAPD patients. Blood Purif. 1989;7(2-3):95-108. doi: 10.1159/000169582.
Bello AK, Okpechi IG, Osman MA, Cho Y, Cullis B, Htay H, Jha V, Makusidi MA, McCulloch M, Shah N, Wainstein M, Johnson DW. Epidemiology of peritoneal dialysis outcomes. Nat Rev Nephrol. 2022 Dec;18(12):779-793. doi: 10.1038/s41581-022-00623-7. Epub 2022 Sep 16.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CIRB-2024-569-5
Identifier Type: -
Identifier Source: org_study_id
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