Long-term clinical effects of a peritoneal dialysis fluid with less glucose degradation products

Background. Glucose degradation products (GDPs) are cytotoxic in vitro and potentially toxic in vivo during peritoneal dialysis (PD). We are presentin g the results of a two-year randomized clinical trial of a new PD fluid, pr oduced in a two-compartment bag and designed to minimize heat-induced gluco se degradation while producing a near neutral pH. The effects of the new fl uid over two years of treatment on membrane transport characteristics, ultr afiltration (UF) capacity? and effluent markers of peritoneal membrane inte grity were investigated and compared with those obtained during treatment w ith a standard solution. Design. A two-group parallel design with 80 continuous ambulatory peritonea l dialysis patients was used. The patients were randomly assigned to either the new fluid (N = 40) or to a conventional one (N = 40), and were stratif ied with respect to age, diabetes, and time on PD. Peritoneal transport cha racteristics were assessed by the Personal Dialysis Capacity (PDC(TM)) test at 1, 6, 12, 18. and 24 months after inclusion and by weighing the overnig ht bag daily. Infusion pain and handling were evaluated using a questionnai re. Peritoneal mesothelial and interstitial integrity were evaluated by ana lyzing overnight effluent dialysate concentrations of CA 125, hyaluronan (H A), procollagen-1-C-terminal peptide (PICP), and procollagen-3-N-terminal p eptide (PIIINP) at 1, 6, 12, 18, and 24 months. Results. The handling of the new two-compartment bag was considered easy, a nd there were no indications of increased discomfort with the new system. F urthermore, no changes in peritoneal fluid or solute transport characterist ics were observed during the study period for either fluid, and neither wer e there any differences with regard to peritonitis incidence. However, sign ificantly higher dialysate CA 125 (73 +/- 41 vs. 25 +/- 18 U/mL), PICP (387 +/- 163 vs. 244 +/- 81 ng/mL), and PIIINP (50 +/- 24 vs. 29 +/- 13 ng/mL) and significantly lower concentrations of HA (395 +/- 185 vs. 530 +/- 298 n g/mL) were observed in the overnight effluent during treatment with the new fluid. Conclusions. We conclude that the new fluid with a higher pH and less GDPs is safe and easy to use and has no negative effects on either the frequency of peritonitis or peritoneal transport characteristics as compared with co nventional ones. Our results indicate that the new solution causes less mes othelial and interstitial damage than conventional ones; that is, it may be considered more biocompatible than a number of conventional PD solutions c urrently in use.