title: Novel online infusate-assisted dialysis system performs microbiologically safely.
abstract: Administration of adequate amounts of commercial infusion fluids renders modern convective dialysis modalities, such as hemodiafiltration, labor-intensive and costly. Preparation of infusate by cold sterilization of dialysis fluid, which is abundantly available, and its immediate (online) use, in contrast, enables a large volume fluid exchange in a cost-effective manner. Recent developments aimed at more hygienic and user-friendly online systems with increased operational flexibility. As a result the novel ONLINEplus system does not only provide online prepared infusate for convective dialysis therapy, but also for priming and rinsing of the extracorporeal blood circuit, for intradialytic bolus administration, and for re-infusion of patients' blood as well. Production of infusate from potentially impure dialysis fluid containing endotoxins and other pyrogens raises severe concerns of affecting the patients' well-being. To assess its safety, the online system was challenged with microbially contaminated dialysis fluid. Despite high levels of microbial counts (7.5 x 104 +/- 105 CFU/ml), endotoxin concentration (14.1 +/- 7.7 IU/ml and 9.265 +/- 3.000 IU/ml, as measured turbidimetrically and chromogenically, respectively) and cytokine-inducing activity (20,827 +/- 3,082 pg IL-1Ra/Mio WBC), we failed to detect contaminants in the final infusate during a 5 week laboratory testing period. In addition, infusate samples complied consistently with the European Pharmacopeia test for sterility. The present online system is comprehensive, operates user-friendly, and provides microbiologically safe infusate in large quantities. In this way, both patients and dialysis staff will benefit from improved dialysis therapy and reduced treatment-related labor burden, respectively. Moreover, convective dialysis modalities will become less expensive.
authors.affiliation: Fresenius Medical Care, Bad Homburg, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Weber
authors.forename: W
authors.initials: W
authors.lastname: Groetsch
authors.forename: S
authors.initials: S
authors.lastname: Schlotter
authors.forename: R
authors.initials: R
authors.lastname: Mitteregger
authors.forename: D
authors.initials: D
authors.lastname: Falkenhagen
mesh_terms: D000704:Analysis of Variance; D016470:Bacteremia / Q000382:microbiology; D001804:Blood Transfusion, Autologous; D002863:Chromogenic Compounds; D015169:Colony Count, Microbial; D003362:Cost-Benefit Analysis; D015314:Dialysis Solutions / Q000008:administration & dosage; D004731:Endotoxins / Q000097:blood; D004866:Equipment Contamination / Q000517:prevention & control; D004869:Equipment Safety; D005112:Extracorporeal Circulation / Q000295:instrumentation; D006090:Gram-Negative Bacteria / Q000145:classification / Q000254:growth & development; D017583:Hemodiafiltration / Q000191:economics / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D007260:Infusion Pumps / Q000382:microbiology; D007375:Interleukin-1 / Q000097:blood; D008070:Lipopolysaccharides / Q000494:pharmacology; D009391:Nephelometry and Turbidimetry; D009862:Online Systems; D011549:Pseudomonas / Q000145:classification / Q000254:growth & development; D011550:Pseudomonas aeruginosa / Q000254:growth & development; D011749:Pyrogens / Q000097:blood; D017472:Receptors, Interleukin-1 / Q000037:antagonists & inhibitors; D012706:Serratia marcescens / Q000254:growth & development; D020615:Stenotrophomonas maltophilia / Q000254:growth & development; D013242:Sterilization; D014409:Tumor Necrosis Factor-alpha / Q000032:analysis; D014584:User-Computer Interface
chemical_list: D002863:Chromogenic Compounds; D015314:Dialysis Solutions; D004731:Endotoxins; D007375:Interleukin-1; D008070:Lipopolysaccharides; D011749:Pyrogens; D017472:Receptors, Interleukin-1; D014409:Tumor Necrosis Factor-alpha