Proof-of-Concept Study of Point-of-Care, On-Demand Dialysate Generation by Viva Komfort Automated Peritoneal Dialysis System in a Porcine Model
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Bibliographic record
Abstract
Background: Peritoneal dialysis (PD) relies on regular delivery of large volume dialysate, posing logistical, storage and environmental burdens. Viva Komfort (VK) Automated PD (APD) system generates dialysate on demand from tap water, potentially eliminating bulk fluid deliveries. While the VK system has a companion cycler, the main aim was to evaluate preliminary safety and biocompatibility of the purified water prepared by on-demand dialysate generation (OnGen) at a modular level in a ESKD porcine PD model. Methods: One male Sus scrofa pig (5/6 nephrectomy) underwent 28 days of APD. In Baseline (Day 1–14), standard Dianeal Low Cal 1.5% dialysate was used and in OnGen (Day 15–28), VK-generated 1.5% dextrose dialysis fluid; VK system infused purified tap water into a prefilled bag of concentrates that would produce dialysate similar to Dianeal Low Cal. In both phases, the same therapy dose was delivered (10h, 2L x 5 exchanges, with 2L Dianeal 1.5% last fill) via HomeChoice Pro as the VK companion cycler was still under development at the time of the study. Tap and purified water were tested on Day 1 prior to the start of the OnGen phase for sterility and endotoxin load. Serum biochemistry and hematology were assessed every 2 days and dialysate cell counts were assessed daily. Drain cultures were done at the start and end of each phase. Results: The pig completed the 28–day study. The purified water produced by the VK met acceptable levels (Sterile, Endotoxin=0.01 EU/mL). No dialysate cultures turned positive through one week post study completion. Median (min–max) values of serum and dialysate parameters remained stable between the phases: Conclusion: On–demand dialysate produced from tap water by the VK APD system was sterile, endotoxin–free, and well tolerated for 14 days in a large animal model, with stable inflammatory profiles and no infectious signals. These proof of concept data support further evaluation of the VK system in extended pre–clinical and forthcoming human studies. Funding: Commercial Support - Vivance Pte Ltd - Baseline Viva Komfort Serum parameters Urea (mmol/L) 11.9 (10.1 – 13.6) 10.2 (9.9 – 11.2) Creatinine (μmol/L) 435 (396 – 455) 449 (424 – 461) CRP (mg/L) 0.5 (0.4 – 2.0) 0.6 (0.5 – 0.7) Dialysate parameters Final Drain Cell count (109/L) 0.002 (0.001 – 0.007) 0.001 (0.001 – 0.003) Turbidity (NTU) 1.3 (1.0 – 1.7) 1.5 (0.8 – 1.8)
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it