Influence of plasticizer-free CAPD bags and tubings on serum, urine, and dialysate levels of phthalic acid esters in CAPD patients

✦ Objectives: To evaluate the impact of a plasticizer-free device on exposure to di-(2-ethylhexyl) phthalate (DEHP) and its major metabolites in patients on continuous ambulatory peritoneal dialysis (CAPD). DEHP is the most commonly used plasticizer in polyvinyl chloride (PVC) products; it is added to CAPD bags in order to improve the flexibility of the material. Since DEHP leaches out of the plastic matrix, patients on CAPD are exposed to considerable amounts of DEHP and its metabolites. ✦ Design: A prospective cross-over study. ✦ Setting: Department of nephrology in a teaching hospital. ✦ Participants: Six patients (4 female, 2 male) stable on peritoneal dialysis (PD) for at least 6 months. ✦ Interventions: Patients were switched from a plasticizer-containing PVC CAPD system (A.N.D.Y. Plus, Fresenius Medical Care, Bad Homburg, Germany) to a polyolefine-made plasticizer-free system (stay-safe, Fresenius). ✦ Main Outcome Measures: Prior to and 42 days after the switch, 24-hour effluent dialysate and urine collections were performed and 10 mL blood was drawn. Concentrations of DEHP, mono-(2-ethylhexyl) phthalate (MEHP), phthalic acid (PA), and 2-ethylhexanol (2-EH) in urine, dialysate, and serum were determined using gas chromatography/ mass spectrometry. ✦ Results: Complete data were obtained from 5 patients. Serum levels of PA decreased significantly during the study period (0.137 ± 0.078 mg/L vs 0.124 ± 0.049 mg/L, p = 0.04), and the respective levels of DEHP decreased insignificantly (0.097 ± 0.076 mg/L vs 0.069 ± 0.046 mg/L, p = 0.07), whereas the concentrations of MEHP and 2-EH remained unchanged. Urine concentrations of PA were high (0.81 ± 0.69 mg/L) but did not change substantially (0.70 ± 0.50 mg/L). Effluent dialysate concentrations of MEHP and PA decreased significantly (0.0176 ± 0.004 mg/L vs 0.0040 ± 0.0007 mg/L, p=0.043 and 0.158 ± 0.056 mg/L vs 0.111 ± 0.051 mglL, p = 0.043, respectively). ✦ Conclusions: Although PD patients seem to be exposed to other sources of phthalates in addition to dialysis, use of plasticizer-free devices may help to reduce potentially immunosuppressive exposure to phthalate esters.