A Randomized Clinical Trial with a 0.6% Amino Acid/1.4% Glycerol Peritoneal Dialysis Solution

Abstract

Background Glucose is an accepted osmotic agent for peritoneal dialysis (PD) although it has several drawbacks. Some of these drawbacks have been addressed by the introduction of solutions with low glucose degradation products and physiological pH in dual-chambered bags. Despite this achievement, there is a need for alternative osmotic agents. This randomized clinical trial analyzes 3-month's clinical experience with a mixture of 0.6% amino acids and 1.4% glycerol. Methods The study was performed at the renal units of the University Hospitals Ghent, Belgium, and Utrecht, The Netherlands. Stable PD patients were randomized for either protocol A (test solution, n = 5) or protocol B (control regimen, n = 5). In both protocols, there was a run-in phase of 1 month with a dialysis regimen of 2 × 2 L 2.27% glucose solution (Dianeal; Baxter, Nivelles, Belgium), 1 × 2 L Extraneal (Baxter), and 1 × 2 L glucose solution (Dianeal). After this month-long run-in period, patients in group A received during 3 months 2 × 2 L amino acid/glycerol solution, 1 × 2 L Extraneal, and at least 1 × 2 L of a classic glucose solution. Results Glucose absorption decreased in the test group during the test phase (from 84.2 ± 8.7 to 11.7 ± 11.6 g/24 hours, p = 0.001). Dialysate levels of cancer antigen 125 (CA125) increased in the test group, from 17.5 ± 11.0 to 32.4 ± 4.6 units/L ( p = 0.04), whereas, in the control group, the levels remained stable (15.5 ± 8.7 and 14.9 ± 9.8 units/L respectively, p = 0.4). There were no differences in serum urea, serum bicarbonate, serum osmolarity, serum albumin, or parameters related to skin-fold thickness or serum glycerol levels between control and test solutions. No differences were observed in obtained ultrafiltration after a 4-hour dwell with 2.27% glucose or the test solution, both measured at week 4 of the run-in period and week 12 of the test period. Conclusion This study demonstrated that the use of a new 0.6% amino acid/1.4% glycerol-containing dialysis solution is safe and well tolerated. Glucose load was reduced significantly and dialysate CA125 levels improved significantly. Ultrafiltration was comparable with that of a 2.27% glucose solution. All these factors, in combination with the potential nutritional benefits, can contribute to a beneficial impact on the success of the PD technique. Further long-term studies in larger patient groups are warranted to explore the potential of this promising new solution.

The osmo-metabolic approach: a novel and tantalizing glucose-sparing strategy in peritoneal dialysis

“…This concept is supported by a randomized, 3-months trial in nondiabetic CAPD patients, comparing the effects of a PD solution with a mixture of 0.6% amino acids and 1.4% glycerol replacing two 2.27% glucose-based conventional solutions (which were used in the control group) [ 53 ]. Glycerol (molecular weight 92 Da) acts as an energy source by entering the glycolytic pathway through the Krebs cycle.…”

“…On the other hand, the reduced concentration of AA (0.6%) may allow a twice daily use of the solution, with AA exchange comparable to a single 1.1% amino acid daily exchange [ 22 ]. Clinical use of the 0.6% AA/1.4% glycerol PD solution proved to be safe and well tolerated, with a significant reduction of glucose absorption, an ultrafiltration capacity comparable to glucose, and increased dialysate levels of CA 125, the latter possibly indicating better preservation of mesothelial cell mass and, potentially, better biocompatibility [ 53 ].…”

“Biocompatible” Neutral pH Low‐GDP Peritoneal Dialysis Solutions: Much Ado About Nothing?

“…Given the evidence for the peritoneal membrane toxicity of glucose and its metabolites, many failed attempts have been made to identify other suitable osmotic agents. For example, glycerol was proven ineffective for UF due to rapid absorption unless mixed with amino acids, and its use was associated with metabolic abnormalities such as hyperlipidemia . Colloidal albumin was found to be effective for UF but limited by high cost and drain pain .…”

In Search of the Holy Grail and the Golden Fleece

“…An alternative for achieving better volume control might be the combination of 0.6% amino acids / 1.4% glycerol (13). This solution can be produced in a single bag at neutral pH, contains no GDPs, and results in an ultrafiltration comparable to that of 2.27% glucose.…”