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A new neutral-pH low-GDP peritoneal dialysis fluid
Rainer Himmele1, Lynn Jensen, Dominik Fenn
1Fresenius Medical Care North America, Waltham, Massachusetts, USA.
Summary
New Delflex Neutral pH peritoneal dialysis fluid (PDF) offers a safe and effective option for patients, maintaining a neutral pH and low glucose degradation products (GDPs). This addresses a critical need for improved dialysis solutions in the United States.
Area of Science:
- Nephrology
- Biocompatible Materials
- Medical Device Analysis
Background:
- Conventional peritoneal dialysis fluids (PDFs) are acidic and generate high glucose degradation products (GDPs) during sterilization.
- Limited availability of neutral-pH, low-GDP PD solutions in the United States.
- Delflex Neutral pH is the first neutral-pH PDF approved by the US FDA.
Purpose of the Study:
- To evaluate the pH and GDP concentrations in Delflex Neutral pH PDF.
- To assess patient ability to correctly mix the new PDF.
- To compare GDP levels with other commercially available biocompatible PDFs.
Main Methods:
- Analyzed pH in 288 samples of Delflex Neutral pH solution.
- Assessed mixing accuracy in 26 patients.
- Measured concentrations of 10 different GDPs in various PDFs.
Main Results:
- Delflex Neutral pH consistently maintained a pH of 7.0 ± 0.4, unaffected by mixing errors.
- Delflex Neutral pH, Balance, BicaVera, and Gambrosol Trio showed similar low total GDP concentrations.
- Physioneal had significantly higher GDPs, while Extraneal had lower GDPs than 4.25% glucose solutions.
Conclusions:
- Delflex Neutral pH PDF reliably provides a neutral pH.
- The new PDF demonstrates minimal glucose degradation products.
- This offers a promising alternative for peritoneal dialysis patients.
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