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Abstract: TH-OR67

Initial Evaluation of Sodium-Free Intraperitoneal 30% Icodextrin/10% Dextrose Solution to Test Short-Term Safety, Tolerability, and Preliminary Efficacy

Session Information

Category: Dialysis

  • 802 Dialysis: Home Dialysis and Peritoneal Dialysis

Authors

  • McIntyre, Christopher W., London Health Sciences Centre London Kidney Clinical Research Unit, London, Ontario, Canada
  • Deleaval, Patrik, London Health Sciences Centre London Kidney Clinical Research Unit, London, Ontario, Canada
  • Penny, Jarrin D., London Health Sciences Centre London Kidney Clinical Research Unit, London, Ontario, Canada
  • Freeman, Amy, London Health Sciences Centre London Kidney Clinical Research Unit, London, Ontario, Canada
Background

Currently used peritoneal dialysis (PD) solutions contain salt limiting their diffusive ability to remove sodium (Na). Na removal is largely dependent on convection, and this becomes increasingly challenging with impending ultrafiltration failure, leading to accumulation of tissue based Na and contributing to increased morbidity/mortality. The aim of this study was to demonstrate the short-term safety, tolerability, and efficacy of a Na-free, PD solution (based 30% Icodextrin) to achieve high-efficiency peritoneal Na and volume removal.

Methods

We studied 10 patients in a single-arm, open label, interventional trial. Stable PD patients aged > 18 years without uncontrolled diabetes mellitus or active infections were enrolled. Study participants received one 4-6-hour dwell of a Na-free PD solution (500 ml instillation volume). They were monitored for pain, hemodynamics, serum sodium and peritoneal removal of sodium and water.

Results

Participants who completed the study reported mild to moderate abdominal pain (1-2/5 pain scale). BP, HR, cardiac output, and stroke volume did not change throughout procedure. Total Na removed per session was 5.69 ± 0.88 g (effluent), ultrafiltrate volume removed was 1975 ± 319 mL, total weight reduction 1.02 ± 0.24kg (p= 0.03). Serum Na remained stable throughout treatment (134.4 ± 5.7mmol/L - 133.3 ± 6.8mmol/L). Na concentration in effluent progressively increased each hour from 90.80 ± 12.36 to 125.4 ± 7.61 mmol/L (p = 0.002). Serum osmolality remained unchanged

Conclusion

We have demonstrated the safety, efficacy, and tolerability of a new Na-free hypertonic PD solution, able to remove >5 g of Na and approximately 2 L of fluid in a single session, without hemodynamic challenge or short term hyponatremia.