Randomized controlled study of biocompatible peritoneal dialysis solutions: Effect on residual renal function

Abstract

Residual kidney function is important for patient and technique survival in peritoneal dialysis (PD). Biocompatible dialysis solutions are thought to improve function and viability of peritoneal mesothelial cells and to preserve residual renal function (RRF). We conducted a randomized controlled study comparing use of biocompatible (B) with standard (S) solutions in 93 incident PD patients during a 1-year period. The demographics, comorbidities, and RRF of both groups were similar. At 3 and 12 months, 24-h urine samples were collected to measure volume and the mean of urea and creatinine clearance normalized to body surface area. Surrogate markers of fluid status, diuretic usage, C-reactive protein concentration, peritonitis episodes, survival data, and peritoneal equilibrium tests were also collected. Changes in the normalized mean urea and creatinine clearance were the same for both groups, with no significant differences in secondary end points. Despite non-randomized studies suggesting benefits of these newer biocompatible solutions, we could not detect any clinically significant advantages. Additional studies are needed to determine if advantages are seen with longer term use.

Effects of Biocompatible versus Standard Fluid on Peritoneal Dialysis Outcomes

“…26 Because biocompatible solutions are quite variable with respect to their GDP content, such heterogeneity might explain potentially conflicting trial results. For example, the absence of beneficial effect in the randomized trial by Fan et al 15 could be explained by the fact that 91% of patients in the intervention group received Physioneal, which is reported to contain levels of 3-dexoyglucosone (70-161 mmol/L depending on dialysate glucose concentration 27 ) that are intermediate between those of the intervention group (42-60 mmol/L) and the control group (173-324 mmol/L) in this study. 28 An alternative explanation for a possible renoprotective benefit of biocompatible fluid is reduced peritonitis risk.…”

“…In contrast, a number of randomized controlled trials have not shown any beneficial effect of biocompatible fluids on residual renal function. [15][16][17][18][19] Common features of these trials were that they were underpowered, did not consider nonlinear decline of renal function in their analytic models, and generally enrolled prevalent patients with lower baseline levels of renal function. As with other studies, 22,24 we observed that renal function decline over time was nonlinear, was most marked in the first year of PD, and tended to be slower with biocompatible fluid use in this first year (although not statistically significant).…”

“…8 Subsequently, a large, retrospective, observational cohort study in Korea 9,10 demonstrated an association between the use of neutral pH, lactate-buffered, low GDP fluids and superior survival, although this finding was potentially limited by indication bias with residual confounding. 11 Several small, short-term, randomized controlled trials have also reported that neutral pH, low GDP fluids were associated with either a beneficial [12][13][14] or neutral [15][16][17][18][19] effect on residual renal function. However, these studies were limited by insufficient statistical power, shortterm follow-up, high drop-out rates, treatment-associated changes in fluid status and often poor methodologic quality, enrollment of prevalent PD patients, and single-center designs.…”

Strategies for Improving Long-Term Survival in Peritoneal Dialysis Patients

“…There was also a significant decrease in the levels of circulating AGEs and inflammatory cytokines. In contrast, Fan et al (28) found no difference in PM function between patients using biocompatible solutions (Physioneal or Balance) or conventional dialysis solutions. A recent study by Lee et al (56) also found no significant improvement in PD technique survival with biocompatible solutions.…”

“…The BALNET study had longer follow-up compared with the Euro-Balance trial, but baseline rGFR was significantly higher in the group randomized to Balance solution and the study lacked sufficient power to detect a statistically significant difference in RRF between the groups. A recent randomized trial by Fan et al (28) of biocompatible solutions (Physioneal or Balance) versus conventional solutions found no difference in RRF between the groups. Unlike the previous two trials, this trial was powered to detect differences in RRF between the two groups; however, the short follow-up time in this study (9 months) is an important limitation.…”