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Abstract: PO0960

On-Demand Automated Peritoneal Dialysis Solution Generation

Session Information

Category: Dialysis

  • 702 Dialysis: Home Dialysis and Peritoneal Dialysis

Authors

  • Uribarri, Jaime, Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Aslam, Nabeel, Mayo Clinic's Campus in Florida, Jacksonville, Florida, United States
  • Edwards, Clinton, Saint Bernards Healthcare, Jonesboro, Arkansas, United States
  • Yamagata, Lara Marie, Baxter Healthcare Corporation, San Gwann, Malta
  • Wellings, Anders J., Baxter Healthcare Corporation, Deerfield, Illinois, United States
  • Wilmington, Alyssa, Baxter Healthcare Corporation, Deerfield, Illinois, United States
  • Tran, Ha, Baxter Healthcare Corporation, Deerfield, Illinois, United States
Background

While automated peritoneal dialysis (APD) is an effective treatment for kidney failure, ordering, delivery and storage of supplies can be challenging. The APD Solution Generation System (SGS) allows for dialysate solution generation using tap water in a patient’s home with fewer supplies (Figure 1).

Methods

A 12-week single-arm, prospective, descriptive study was conducted with in-home APD patients. Patients were screened, trained and treated with the SGS. Endpoints included testing the final product against specifications for Dianeal and water purification ISO Standard 13959 and measuring PD adequacy. Adverse events and device deficiencies were collected.

Results

22 patients were enrolled; 14 patients completed the study. Demographics are shown in Table 1. See Figure 1 for primary efficacy and safety endpoint results. All tested post-sterilization filter and final dialysis solution samples passed. Missing data for water purity attributed to only 56.9% of samples passing. Mean (SD) change from baseline for Kt/V was -0.15 (0.370). There were 2 peritonitis events (0.43 episodes per patient-year), 1 occurring in a patient with HIV. There were no safety signals.

Conclusion

The SGS has the technical capability to accurately and safely generate dialysate at home using tap water. Logistical challenges with lab sampling require further exploration to understand the impact in future trials and real-world settings. Lessons learned from the study allow for transition of the device to future development.

Table 1. Demographics (n=22)
Age (Mean ±SD)61.9 ±13.7
Female (n(%))14 (63.6)
Black (n(%))7 (31.8)
Hispanic or Latino (n(%))2 (9.1)
Baseline Kt/Vurea (Mean ±SD)2.4 ±0.6

Figure 1. APD Solution Generation System and Main Results