Transfer and Ultrafiltration In Peritoneal Dialysis

Study Overview
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Brief Summary
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The aim of this study is to demonstrate the efficiency of an adapted and alternate peritoneal dialysis scheme in terms of sodium extraction and purification compared to an adapted conventional peritoneal dialysis scheme.

Official Title
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Transfer and Ultrafiltration In Peritoneal Dialysis

Conditions
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End-stage Renal Disease

Intervention / Treatment
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* Other: comparison of two regimens in peritoneal dialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients hospitalized in the Nephrology department of the Besançon University Hospital Patients treated by continuous ambulatory peritoneal dialysis or ambulatory peritoneal dialysis for at least 6 months Absence of hospitalization caused by an infection in the month prior to inclusion Patients with a ratio (D / P) of the concentration of creatinine in the blood and dialysate between 0.5 and 0.8 on a checkup of less than 1 year. No contraindication to the use of hypertonic bag Signature of informed consent for participation indicating that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study Affiliation to a French social security system or beneficiary Exclusion Criteria: Legal incapacity or limited legal capacity Patients unlikely to cooperate in the study and/or low cooperation anticipated by the investigator Patients without health insurance Pregnant women Patient being in the exclusion period from another study or planned by the national register of volunteers Hospitalization caused by an infection in the month prior to inclusion Patients with a peritoneal dialysis catheter dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conventional scheme followed by alternate schem<br>The first day of the study, patients receive an adapted conventional peritoneal dialysis scheme: 2 cycles of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 2 cycles of purification (stasis: 110 mn ; volume 1200cc/m²). The second day, patients receive an adapted and alternate scheme: 1 cycle of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 1 cycle of purification (stasis: 110 mn ; volume 1200cc/m²), the two cycles being repeated once. | Other: comparison of two regimens in peritoneal dialysis<br>* Dialysate samples (8 by scheme, volume of 10 mL) are collected at each cycle (one at the beginning and one at the end of the cycle). A blood sample (5 mL) is collected at the beginning of the second scheme and a 24-hour urine sample at the end of the second scheme.<br>|
| Experimental: alternate scheme followed by conventional scheme<br>The first day of the study, patients receive an adapted and alternate peritoneal dialysis scheme: 1 cycle of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 1 cycle of purification (stasis: 110 mn ; volume 1200cc/m²), the two cycles being repeated once. The second day, patients receive an adapted conventional scheme: 2 cycles of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 2 cycles of purification (stasis: 110 mn ; volume 1200cc/m²). | Other: comparison of two regimens in peritoneal dialysis<br>* Dialysate samples (8 by scheme, volume of 10 mL) are collected at each cycle (one at the beginning and one at the end of the cycle). A blood sample (5 mL) is collected at the beginning of the second scheme and a 24-hour urine sample at the end of the second scheme.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-dialytic concentrations of different electrolytes (sodium, phosphorus, urea, creatinine, glucose and proteins) |  | In a maximum of 72 hours after collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nephrology, extra-renal purification, peritoneal dialysis