Optimized vs. Standard Automated Peritoneal Dialysis Regimens Study

Study Overview
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Brief Summary
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This clinical study is designed to evaluate the theoretical prediction of a lower glucose absorption in optimized automated peritoneal dialysis regimes. Patients will receive both a standard 6 x 2L 1.36% glucose regime or an optimized 7 x 2 L 2.27% glucose + 5 x 2 L 0.1% glucose regime in a crossover fashion.

Detailed Description
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Automated peritoneal dialysis (APD) is a rapidly growing, home-based kidney replacement therapy promoting patient autonomy, and is associated with lower societal costs compared to hemodialysis. However, in light of the growing number of diabetic patients on PD, the unwanted glucose absorption during APD is problematic. Recent results (Öberg CM, Rippe B, 2017, see references), using a theoretical model of APD, indicate that large reductions in glucose absorption are possible by using specialized so-called optimized bi-modal treatment regimes having UF cycles using a higher glucose concentration (e.g. 2.27% glucose) and Clearance cycles using a low glucose concentration (e.g. 0.1% glucose).

Official Title
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Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): A Randomized Controlled Trial

Conditions
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End Stage Kidney Disease, Chronic Kidney Disease Requiring Chronic Dialysis

Intervention / Treatment
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* Procedure: Automated peritoneal dialysis (APD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 75 years; duration of PD (automated peritoneal dialysis (APD) or continuous ambulatory peritoneal dialysis (CAPD)) >4 weeks Exclusion Criteria: severe heart failure (New York Heart Association Functional Classification; NYHA III or IV); pregnancy; catheter malfunction or peritonitis within 3 months prior to the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br>APD-treatment with a net volume of 12 L 1.36 % anhydrous glucose peritoneal dialysis solution during 540 minutes. | Procedure: Automated peritoneal dialysis (APD)<br>* Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler.<br>|
| Active Comparator: Optimized treatment<br>APD-treatment with a net volume of 14 L 2.27 % anhydrous glucose peritoneal dialysis solution during 280 minutes followed by a net volume of 10 L 0.1 % glucose dialysis fluid during 200 minutes. | Procedure: Automated peritoneal dialysis (APD)<br>* Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose absorption | Amount of glucose absorbed across the peritoneal membrane during the treatment | Through study completion, up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrafiltration | Amount of water transported from the circulation to the peritoneal cavity during the treatment | Through study completion, up to 1 year | 
| Creatinine clearance | Amount of creatinine transported from the circulation to the peritoneal cavity during the treatment | Through study completion, up to 1 year | 
| Urea clearance | Amount of urea transported from the circulation to the peritoneal cavity during the treatment | Through study completion, up to 1 year | 
| Sodium removal | Amount of sodium transported from the circulation to the peritoneal cavity during the treatment | Through study completion, up to 1 year | 
| Incidence of complications | Complications that are or can be suspected to be related to the study intervention | Up to 14 days post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dialysis, peritoneal dialysis