The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition

Study Overview
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Brief Summary
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Chronic utilization of bio-incompatible peritoneal dialysis (PD) solution has been implicated as a cause of progressive loss of peritoneal permeability and recurrent fluid overload in PD patients. Previous studies show that PD solution with neutral pH and low GDP resulted in a superior profile of PD effluent mesothelial cell marker and a lower degree of systemic inflammation as compared to conventional PD solution. The investigators propose a prospective randomized control study to compare the arterial stiffness, nutrition and body fluid status between PD patients treated with conventional solution and those with neutral pH low GDP solution. The investigators plan to study 100 new PD patients. They will be randomized to be treated with neutral pH low GDP solution or conventional solution. All patients will be followed for 52 weeks. In addition to routine clinical measurements, the investigators will measure their body water composition by bioimpedance spectroscopic method, arterial pulse wave velocity by pressure transduction method, as well as radiographic parameters of intravascular volume status, based on the routine chest radiograph. The study would help to define the clinical benefit of biocompatible PD solution.

Detailed Description
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(see above)

Official Title
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The Effect of Neutral Peritoneal Dialysis Solution With Minimal Glucose-Degradation-Product on the Fluid Status and Body Composition - A Randomized Control Trial

Conditions
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ESRD, Renal Failure, Cardiovascular Disease

Intervention / Treatment
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* Other: double-chamber bag Stay-Safe Balance system
* Other: glucose-based dialysis solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: new adult continuous ambulatory peritoneal dialysis (CAPD) patients, both diabetic and non-diabetic Exclusion Criteria: unlikely to survive, planned to have elective living-related kidney transplant, or transfer to other renal center within 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balance group<br>peritoneal dialysis with neutral peritoneal dialysis solution with minimal glucose-degradation-product | Other: double-chamber bag Stay-Safe Balance system<br>* 2-L exchange; three times a day<br>* Other names: Stay-Safe Balance system;|
| Active Comparator: Control group<br>conventional PD solution | Other: glucose-based dialysis solution<br>* 2-L exchange; three times a day<br>* Other names: Stay-Safe, Fresenius;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition |  | 52 weeks | 
| arterial pulse wave velocity |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional and adequacy indices |  | 52 weeks | 
| peritoneal transport characteristics |  | 52 weeks | 
| residual renal function |  | 52 weeks | 
| peritonitis-free survival, actuarial and technique survival |  | 52 weeks | 
| hospitalization |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malnutrition, fluid status, survival