First-in-Human Experience With Peritoneal Direct Sodium Removal Using a Zero-Sodium Solution: A New Candidate Therapy for Volume Overload
Authors' conclusion
DSR was well tolerated in both animals and human subjects and produced substantially greater sodium removal than standard PD solution.
Study context
- Population
- Patients with end-stage renal disease on peritoneal dialysis; preclinical porcine experiments
- Comparison
- DSR solution vs standard peritoneal dialysis (PD) solution
- Primary endpoint
- Completion of the 2-hour dwell without significant discomfort or adverse events
- Follow-up
- 2 hours
Methodological detailsfirst-in-human proof of concept
- First-in-human proof of concept
Primary result
As reported in the abstract
Completion of 2-hour dwell without significant discomfort or adverse events
- DSR solution well tolerated and not associated with significant discomfort or adverse events
Secondary outcomes
Sodium removal (human) · 2 hours
P < 0.0001
- Sodium removal, porcine (1 L DSR) · 2 hours
- 4.1 · ± 0.4 · g
- Sodium removal, porcine (1 L DSR) — Increasing DSR volume increased sodium removal and substantially decreased plasma volume
- P=0.005
- Sodium removal, porcine (1 L DSR) — Sodium removal ≈4 times greater in experimental heart failure (HF) with elevated right atrial pressure than in healthy animals
- P<0.001
Safety
Plasma electrolytes and off-target solute removal (human)
- Plasma electrolytes stable; off-target solute removal negligible
Original publication
First-in-Human Experience With Peritoneal Direct Sodium Removal Using a Zero-Sodium Solution: A New Candidate Therapy for Volume Overload. Circulation. Published 8 January 2020. doi:10.
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