Rationale and design of the CORDIAL first-in-human clinical trial: A system for sorbent-assisted continuous flow peritoneal dialysis.

Abstract

Peritoneal dialysis (PD) has important disadvantages compared to hemodialysis, including low plasma clearance and limited technique survival. A new device for sorbent-assisted (continuous flow) peritoneal dialysis (SAPD) has been designed that is based on continuous recirculation of peritoneal dialysate via a single-lumen peritoneal catheter with regeneration of spent dialysate by sorbents. SAPD treatment may enhance plasma clearance of uremic solutes by increasing the mass transfer area coefficient and maintenance of a high plasma-to-dialysate concentration gradient. In addition, SAPD treatment may preserve integrity of the peritoneal membrane for a longer period of time by avoiding the need for high initial glucose concentrations and by reducing the number of exchanges and (dis)connections of the peritoneal catheter, which may lower the risk of peritonitis. The primary aim of this first-in-human clinical trial is to evaluate the (short-term) clinical safety and performance of SAPD treatment in a small group (n = 12) of stable adult PD patients in a clinical setting (proof of concept). Key secondary objectives include an evaluation of efficacy in terms of plasma clearance, ultrafiltration, and patient tolerance.