Effects of biocompatible versus standard fluid on peritoneal dialysis outcomes

Abstract

The clinical benefits of using "biocompatible" neutral pH solutions containing low levels of glucose degradation products for peritoneal dialysis compared with standard solutions are uncertain. In this multicenter, open-label, parallel-group, randomized controlled trial, we randomly assigned 185 incident adult peritoneal dialysis patients with residual renal function to use either biocompatible or conventional solution for 2 years. The primary outcome measure was slope of renal function decline. Secondary outcome measures comprised time to anuria, fluid volume status, peritonitis-free survival, technique survival, patient survival, and adverse events. We did not detect a statistically significant difference in the rate of decline of renal function between the two groups as measured by the slopes of GFR: -0.22 and -0.28 ml/min per 1.73 m(2) per month (P=0.17) in the first year in the biocompatible and conventional groups, respectively, and, -0.09 and -0.10 ml/min per 1.73 m(2) per month (P=0.9) in the second year. The biocompatible group exhibited significantly longer times to anuria (P=0.009) and to the first peritonitis episode (P=0.01). This group also had fewer patients develop peritonitis (30% versus 49%) and had lower rates of peritonitis (0.30 versus 0.49 episodes per year, P=0.01). In conclusion, this trial does not support a role for biocompatible fluid in slowing the rate of GFR decline, but it does suggest that biocompatible fluid may delay the onset of anuria and reduce the incidence of peritonitis compared with conventional fluid in peritoneal dialysis.

Figure 1.

Consolidated Standards of Reporting Trials diagram showing the number of patients recruited into the balANZ study, randomized, followed, and analyzed. APD, automated PD; SAE, serious adverse event; ITT, intention to treat.

Figure 2.

Nonsignificant difference in residual renal function decline over 2 years in the biocompatible and control groups. (A) The biocompatible group. (B) Controls. Gray lines represent individual patient measurements, whereas solid lines represent predicted slopes in the first and second 12-month follow-up periods. The P value for the three-way interaction of year (first 12 months versus second 12 months) by GFR slope by dialysate was 0.06.

Figure 3.

Kaplan–Meier survival analysis for time to anuria in balANZ trial participants over the 2-year study period. The differences between the biocompatible and control groups were statistically significant (P=0.009). Numbers at risk are indicated above the abscissa.

Figure 4.

Kaplan–Meier survival analysis for time to first peritonitis episode in balANZ trial participants over the 2-year study period. The difference between the biocompatible and control groups was statistically significant (P=0.01). Numbers at risk are indicated above the abscissa.