#1328 Novel tidal, steady-concentration sorbent-based PD (viva kompact) reduces glucose exposure and maintains target weight: a comparative pilot study vs. conventional PD

Abstract Background and Aims In conventional PD (CPD), ultrafiltration (UF) will decline over time with diminishing glucose gradient; necessitating fresh dialysate instillation to reestablish the gradient. Viva Kompact (previously AWAK) is a steady concentration sorbent-based peritoneal dialysis (PD) device which tidals 250 mls per cycle, up to 64 cycles, and regenerates new solution at the rate of 2 L/hour after the initial instillation of dextrose solution1. Fig. 1 illustrates a simulated scenario of glucose concentration in the peritoneum over a therapy. In Viva Kompact the rate of glucose infusion can be adjusted between 4 settings (0.4–1.6 ml/cycle of 70% dextrose) based on subject’s need, guided by a nomogram. Therapy time can vary between 7 to 9 hours. This study aims to evaluate the UF patterns and efficiency, with subjects as their own control, while on the Viva Kompact device as compared to CPD. Method At Singapore General Hospital between May 2023 to February 2024, 14 subjects were screened and underwent a titration period (up to 21 days), a washout (minimum 2 days), and an at-home treatment period (7 days). Three subjects were offered an optional extension (23 days). During titration a nomogram guide for steady concentration PD was employed to determine cartridge type, therapy duration, initial fill tonicity (Dianeal Low Calcium 1.5%, 2.5% or 4.25%). Overall, as a UF surrogate, dry body weight was used. The aim was to have subjects maintaining their body weight within 5% of target dry weight (average dry weight of Screening and pre-Titration Day 1). CPD (baseline) 24-hour dialysate data was collected at Screening. Daily weight and UF data were collected on all participants when they started the use of Viva Kompact. Fill volumes were kept similar during CPD and Viva Kompact therapy. Dialysate samples were collected on Treatment Day 1 (Cycle 4, 8, 40, 54 and Final drain). Safety bloods were done throughout the study (Day 4, 7, 14, 21 and 30). Calculation of UFEexp / UFEabs (UF generated in 24 hours per gram of glucose monohydrate exposed/absorbed) were derived from these datapoints Descriptive statistics (median, min, max) were used in analysis, with significance testing reported using Wilcoxon signed rank test. Results 11 out of 14 subjects were enrolled in the study; 2 failed screening and 1 withdrew during the Titration phase. 10 subjects completed the 7-day Treatment period and 3 subjects continued to the 23-day Optional Extension period. 1 subject withdrew on the sixth day of Treatment and was included in the analysis. Table 1 shows the demographic summary of the analysed subjects. Subjects with last fill (n = 6) were continued on Icodextrin 7.5%. All subjects maintained their body weights within 5% of their target body weight (% change in body weight = −0.7% [−4.3–1.3%] during the 7-day Treatment as well as Optional Extension period. Table 2 compares body weight, glucose exposure, absorption, UFEexp, and UFEabs for CPD vs. Viva Kompact. The UFE (exposed) as significantly better in Viva Kompact as compared to CPD; UFEexp = 5.5[2.9–9.6] mL/g vs 1.8[−0.8 – 5.4] mL/g of glucose exposed, p = 0.0034. Whereas, UFE (absorbed) was similar; Viva Kompact = 8.9[4.8–20.3] mL/g vs CPD = 3.1[−2.1–28.7] mL/g of glucose absorbed, p = 0.1835. Throughout the study, subject serum sodium levels also remained stable; Baseline = 138[134–146] mmol/L vs Viva Kompact = 137[132–141] mmol/L. Conclusion This medium-term study demonstrates that steady concentration PD with Viva Kompact is able to maintain patients at their target weight while achieving individually appropriate UF. This approach provides similar UFEabs (UF per gram of glucose absorbed) but significantly improves UFEexp (UF per gram of glucose exposed). The significant reduction in glucose exposure with Viva Kompact may help preserve the peritoneal membrane. Further studies are needed to assess the longer-term impact on technique survival, membrane integrity, and outcomes in PD patients with diabetes.2

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