The Clinical Usefulness of Peritoneal Dialysis Fluids with Neutral pH and Low Glucose Degradation Product Concentration: An Open Randomized Prospective Trial

Abstract

Background Long-term peritoneal dialysis (PD) is associated with the development of various structural and functional changes to the peritoneal membrane when bioincompatible conventional peritoneal dialysis fluids (PDFs) are used. In this study, we looked at patients that were treated with conventional PDFs and then changed to novel biocompatible PDFs with a neutral pH and a low concentration of glucose degradation products (GDPs) to investigate whether this change could result in the arrest or reversal of peritoneal membrane deterioration. Methods In an open label, randomized prospective trial, the clinical effects of conventional PDFs and biocompatible PDFs with neutral pH and very low concentration of GDPs were compared in 104 patients equally divided between both study PDFs. Blood and effluent dialysate samples, peritoneal equilibration tests, and adequacy evaluation were undertaken at baseline, 4, 8, and 12 months. The target variables were the ratio of dialysate-to-plasma (D/P) creatinine, peritoneal ultrafiltration, residual renal function, dialysis adequacy indices, and effluent cancer antigen 125 (CA125). Results D/P creatinine values were not different in the two groups. Peritoneal ultrafiltration was significantly higher in the low-GDP PDF group than in the conventional PDF group at all follow-up times (4 months: 9.1 ± 4.3 vs 6.0 ± 3.0; 8 months: 8.3 ± 3.4 vs 6.0 ± 3.0; 12 months: 8.9 ± 3.3 vs 6.1 ± 3.3 mL/g dextrose/day; p < 0.05). Peritoneal Kt/V urea values and total weekly Kt/V urea values at 4 months were significantly higher in the low-GDP PDF group than in the conventional PDF group. Residual renal function was not statistically significant. Effluent CA125 levels were significantly higher in the low-GDP PDF group at all follow-up visits (4 months: 37.8 ± 20.8 vs 22.0 ± 9.5; 8 months: 41.2 ± 20.3 vs 25.9 ± 11.3; 12 months: 40.4 ± 21.4 vs 28.6 ± 13.0 U/mL; p < 0.05). Among anuric patients, peritoneal ultrafiltration at 4, 8, and 12 months, total weekly Kt/V at 4 and 8 months, and CA125 levels at all follow-up visits were significantly higher in patients treated with low-GDP PDF than those treated with conventional PDF. However, among anuric patients, D/P creatinine showed no significant differences between the low-GDP PDF group and the conventional PDF group. Conclusion The use of biocompatible PDFs with neutral pH and low GDP concentration can contribute to improvement of peritoneal ultrafiltration and peritoneal effluent CA125 level, an indicator of peritoneal membrane integrity in PD patients.

Effects of Icodextrin and Glucose Bicarbonate/Lactate‐Buffered Peritoneal Dialysis Fluids on Effluent Cell Population and Biocompatibility Markers IL‐6 and CA125 in Incident Peritoneal Dialysis Patients

“…There was no effect on systemic inflammatory markers and peritoneal transport remained stable. This observation is in line with several but not all studies, which, however, did not include icodextrin solution‐treated patients.…”

PD solutions: New and old

“…52 A large Korean study showed lower mortality rates in patients using lactate-buffered, neutral pH, low-GDP solutions compared with standard lactate solutions; furthermore, when they used a multivariate Cox regression model, including age, diabetes, and gender, the survival advantage of the more biocompatible solution persisted. 96 In a 3-year prospective, albeit not randomized study, mortality was also determined to be lower with a biocompatible solution that had a pH of 7.4 and low GDP content compared with a standard dialysis solution. 72 Cumulatively, these studies suggest that the newer, more biocompatible solutions may decrease mortality, but more prospective, randomized studies are required for confi rmation.…”

“…In another study from Korea, comparison of low-GDP and standard solutions also provided evidence suggesting that RRF declined less rapidly with Balance compared with standard solutions. 96 However, the analysis was very underpowered and the statistical methods used for the analysis were not optimal.…”

“Biocompatible” Neutral pH Low‐GDP Peritoneal Dialysis Solutions: Much Ado About Nothing?

“…In the context of the aforementioned in vitro and ex vivo studies suggesting peritoneal toxicity and perhaps even direct renal toxicity with low pH and high GDP PD solutions, several trials have been performed to evaluate the effects of NpHLGDP solutions on clinical endpoints such as membrane function, peritoneal UF and RKF. With regards to preservation of RKF, initial studies showed variable results, with some reporting benefit with NpHLGDP solutions (43,(59)(60)(61), while others found none (62)(63)(64). Among subsequently performed trials, the most promising was the balANZ randomized con- Finally, in order to circumvent the limited power of individual studies, a Cochrane review was undertaken by Cho et al (66).…”