RESUMO
BACKGROUND: Automated peritoneal dialysis (APD) provides the opportunity for home-based dialysis, enabling the patient to optimize their lifestyle by maintaining their normal daily routine. Use of a larger bag size and biocompatible solution is desirable. In an effort to further improve patient convenience and reduce the probability of infusing only the buffer contents from the outflow chamber, we designed a 5-L dual-chamber container system with a dual-seal system consisting of a long seal between the dextrose chamber and buffer chambers and a short SafetyMoon™ seal between the buffer chamber and container outflow connector. METHODS: The safety and effectiveness of this new container system was assessed in a non-interventional, prospective, open-label, multi-centre, uncontrolled, Baxter-sponsored post-authorization safety study in 249 patients from 7 countries in Europe. RESULTS: No mis-infusion events were noted throughout the study where 68 519 Physioneal™ 5-L bags in Clear-Flex™ were used for an average (SD) of 4.3 (1.9) months per patient. Overall, the percentage of patients and/or care providers rating the 5-L bag preparation as very easy or easy at baseline (0-8 weeks), 9-16, 17-24 and 25-32 weeks ranged from 94 to 97%. Assuming a Poisson distribution for the bag count data, the estimated change in number of bicarbonate/lactate dialysis fluid bags (5 or 2.5 L) as a percent of prior bag use was -36%, while the estimated change in number of bags for ALL solutions as a percent of prior bag use was -31%. The predominant reasons given by the investigators for prescribing 5-L PD solutions at study onset were biocompatibility, easier and convenient for their patients to use, physiological pH and less bag connections. None of the 92 serious adverse events were suspected to be related to the Physioneal 5-L PD solution. CONCLUSIONS: Use of a larger, Physioneal 5-L bag mitigates the concern regarding the possibility of mis-infusing the buffer chamber solution, is convenient to use by the patient/health care provider and is associated with more than a 30% reduction in the weekly number of dialysis solution bags required per patient for their APD therapy.