Performance Evaluation of an Automated Peritoneal Dialysis Solution Generation System in Patients using Automated Peritoneal Dialysis

Introduction Most patients on peritoneal dialysis (PD) in the United States are on automated PD (APD) utilizing several liters of PD solution daily for their treatment. The ordering, delivery and storage of PD solutions can be a challenging and is an important factor that can dissuade patients from doing PD. The generation of PD solutions at home is a strategy that could potentially be utilized to overcome this problem. The APD Solution Generation System (SGS) allowed for PD solution generation using tap water in patients’ homes. Methods In this study, we set out to evaluate the performance of the SGS in prevalent, adult ESKD patients on maintenance PD. We evaluated the primary safety (microbiological testing) and efficacy (chemical composition) of the product water generated by the SGS device. Results Twenty -two patients from 12 different US centers were enrolled, of which 14 patients completed the study. The results of the primary safety and efficacy endpoint analyses of the product water showed that all 64 samples met the International Organization for Standardization (ISO) specifications. Secondary safety analysis found a total of 34 adverse events in 12 patients, 3 of which were deemed serious treatment-emergent adverse events: culture negative peritonitis, bacterial peritonitis, and atrial fibrillation. Conclusion This study demonstrated that the SGS can successfully generate PD solution in patients’ homes, while meeting chemical composition and ISO microbiological standards. Lessons learned from this clinical trial will be useful in optimizing product development and future clinical trials.