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Kidney Week

Abstract: PO0962

Animal Trial of Sorbent Cartridge for Portable Artificial Kidney (PAK)

Session Information

Category: Dialysis

  • 702 Dialysis: Home Dialysis and Peritoneal Dialysis

Authors

  • Bluechel, Christian G., Dialyss Pte Ltd, Singapore, Singapore
  • Koh, Yen Nee, Dialyss Pte Ltd, Singapore, Singapore
  • Tan, Chieh-suai, Singapore General Hospital, Singapore, Singapore
  • Chen, Kenneth, Singapore General Hospital, Singapore, Singapore
  • Zhuang, Kun Da, Singapore General Hospital, Singapore, Singapore
Background

The NextKidney/Dialyss HD Sorbent Cartridge (SC) uses a novel type of sodium-neutral sorbent to regenerate spent dialysate for standard hemodialysis (HD) therapies. The SC is intended to be used with the NextKidney sorbent HD device, where it produces fully physiological dialysate meeting today’s industry standards. We tested the safety and efficacy of the sorbent system in a total kidney failure pig model. The animals were maintained exclusively on sorbent HD for up to 2 weeks.

Methods

Three highly uremic pigs (60–75Kg) underwent a total of 14 alternate-day, 4h sorbent HD therapy sessions. Total renal failure was induced via bilateral renal artery embolization (pig #1), or bilateral laparoscopic ligation of renal arteries (pigs #2 and 3). A palindrome catheter provided blood flow rates of 200 – 300mL/min. A hemoperfusion machine was used for the blood circuit, coupled with a prototype device controlling the dialysate circuit. Dialysate was continuously purified in the SC at a flow rate of 300 mL/min. Therapy efficacy and mass balances were calculated from blood and dialysate samples collected before and after the dialyzer at specific time points.

Results

The animals tolerated the therapies well. The incision site at the femoral artery of pig #1 re-opened on day 5 after surgery, resulting in internal bleeding and loss of the animal. Fourteen 4hr dialyses were averaged to calculate toxin removal efficacy and mass balances. The average clearances for urea, creatinine and phosphate were 139, 146 and 141mL/min, respectively. Dialysate sodium and bicarbonate concentrations remained within the permissible deviations of +/-5% and +/-25%, respectively.

Conclusion

The biocompatibility of the sorbent system has been confirmed in fourteen 4h HD therapies conducted on three highly uremic pigs. The sorbent system was able to maintain the highly uremic animals. There were no severe adverse events related to the sorbent HD therapy. We currently plan to proceed to a first-in-human trial to evaluate the safety and efficacy of the sorbent cartridge for human use.

Average Dialysate Concentrations
SolutesSpent Dialysate [mmol/L]Regenerated Dialysate [mmol/L]Deviation [%]
Sodium138.0139.30.94
Bicarbonate31.335.212.4
Chloride102.6103.81.24

Funding

  • Commercial Support