Clinical Studies of New Icodextrin Formulations

The osmotic effectiveness of icodextrin as a “colloid” osmotic agent has been well established and shown to be particularly well suited for long dwell exchanges (8 12 hours). More recently, its advanced application generated the first in vivo demonstration of sustained ultrafiltration with hypo-osmolar dialysis solution (i.e., against the osmolality gradient). This led to the “novel” concept of an iso-osmolar combination of “crystalloid” and “colloid” osmotic agents to achieve a range of ultrafiltration optimized for dwell time. In accordance with our objective of developing physiological solutions for all continuous ambulatory peritoneal dialysis (CAPD) exchanges, we tested this hypothesis by comparing an iso-osmolar combination of 2.0% -2.5% of dextrin 20 (Mw 20000 dalton; Mn 5800 dalton) and 0.68% glucose with 1.36% glucose solution in 11 CAPD patients over a 6-hour dwell. An iso-osmolar icodextrin mixture produced ultrafiltration of similar magnitude to that of a 1.36% glucose solution with less than half the calorie load. This solution, therefore, has the potential to replace all the currently used hyperosmolar exchanges with physiological solutions containing half the daily calorie load without exceeding the current safe level of maltose accumulation. This also offers a unique potential for a combination of unrelated but compatible agents, each with its own metabolic advantages, which would offer a wider spectrum of metabolic advantages than a single agent alone.