title: A new neutral-pH low-GDP peritoneal dialysis fluid.
abstract: BACKGROUND
  Conventional peritoneal dialysis fluids (PDFs) consist of ready-to-use solutions with an acidic pH. Sterilization of these fluids is known to generate high levels of glucose degradation products (GDPs). Although several neutral-pH, low-GDP PD solutions have been developed, none are commercially available in the United States. We analyzed pH and GDPs in Delflex Neutral pH (Fresenius Medical Care North America, Waltham, MA, USA), the first neutral-pH PDF to be approved by the US Food and Drug Administration.
  
  
  METHODS
  We evaluated whether patients (n = 26; age range: 18 - 78 years) could properly mix the Delflex Neutral pH PDF after standardized initial training. We further analyzed the concentrations of 10 different glucose degradation products in Delflex Neutral pH PDF and compared the results with similar analyses in other commercially available biocompatible PDFs.
  
  
  RESULTS
  All pH measurements (n = 288) in the delivered Delflex Neutral pH solution consistently fell within the labeled range of 7.0 ± 0.4. Analysis of mixing errors showed no significant impact on the pH results. Delflex Neutral pH, Balance (Fresenius Medical Care, Bad Homburg, Germany), BicaVera (Fresenius Medical Care), and Gambrosol Trio (Gambro Lundia AB, Lund, Sweden) exhibited similar low total GDP concentrations, with maximums in the 4.25% solutions of 88 μmol/L, 74 μmol/L, 74 μmol/L, and 79 μmol/L respectively; the concentration in Physioneal (Baxter Healthcare Corporation, Deerfield, IL, USA) was considerably higher at 263.26 μmol/L. The total GDP concentration in Extraneal (Baxter Healthcare Corporation) was 63 μmol/L, being thus slightly lower than the concentrations in the 4.25% glucose solutions, but higher than the concentrations in the 1.5% and 2.5% glucose solutions.
  
  
  CONCLUSIONS
  The new Delflex Neutral pH PDF consistently delivers neutral pH with minimal GDPs.
authors.affiliation: Fresenius Medical Care North America, Waltham, Massachusetts, USA.
authors.forename: Rainer
authors.initials: R
authors.lastname: Himmele
authors.forename: Lynn
authors.initials: L
authors.lastname: Jensen
authors.forename: Dominik
authors.initials: D
authors.lastname: Fenn
authors.forename: Chih-Hu
authors.initials: CH
authors.lastname: Ho
authors.forename: Dixie-Ann
authors.initials: DA
authors.lastname: Sawin
authors.forename: Jose A
authors.initials: JA
authors.lastname: Diaz-Buxo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015314:Dialysis Solutions / Q000737:chemistry*; D004339:Drug Compounding; D005240:Feasibility Studies; D005260:Female; D005947:Glucose / Q000032:analysis*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis / Q000295:instrumentation* / Q000379:methods / Q000451:nursing; D010537:Peritoneum / Q000737:chemistry / Q000378:metabolism*; D012646:Self Administration; D055815:Young Adult
chemical_list: D015314:Dialysis Solutions; D005947:Glucose