Clinical effects of a peritoneal dialysis regimen low in glucose in new peritoneal dialysis patients: a randomized crossover study.

Standard glucose-based peritoneal dialysis (PD) solutions have unfavorable effects on the peritoneum and contribute to metabolic abnormalities. A PD regimen in which solutions with an alternative osmotic agent (icodextrin, amino acids) and solutions with a bicarbonate/lactate buffer are combined may reduce those effects. In a prospective crossover study, we randomized new continuous ambulatory peritoneal dialysis (CAPD) patients to one of two groups. One group used 4 exchanges of standard PD (SPD) solution (Dianeal: Baxter Healthcare BV, Utrecht, Netherlands) daily. The second group used 1 exchange of Nutrineal (Baxter Healthcare BV), 1 exchange of Extraneal (Baxter Healthcare BV), and 2 exchanges of Physioneal (Baxter Healthcare BV) daily (NEPP). After 30 weeks of treatment, each group switched over to the other regimen for 24 weeks. Statistical analysis used analysis of variance (ANOVA) for repeated measurements. Of the 74 patients enrolled into the study, 50 completed the full study period (24 NEPP-SPD, 26 SPD-NEPP). With regard to daily ultrafiltration and dialysis efficacy (Kt/V), the NEPP regimen was as efficacious as the standard regimen. The NEPP regimen was found to be safe: body weight, blood pressure, decline in urine volume, residual creatinine clearance, and laboratory measurements did not differ statistically significantly from those measured in the standard regimen. The NEPP regimen was well tolerated and was not accompanied by serious side effects. During the NEPP regimen, bicarbonate was found to be significantly higher in both groups. The NEPP regimen is a feasible treatment schedule for patients starting CAPD.

RCT Entities:   Population Interventions Outcomes