A randomized clinical trial with a 0.6% amino acid/ 1.4% glycerol peritoneal dialysis solution.

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 x 2 L 2.27% glucose solution (Dianeal; Baxter, Nivelles, Belgium), 1 x 2 L Extraneal (Baxter), and 1 x 2 L glucose solution (Dianeal). After this month-long run-in period, patients in group A received during 3 months 2 x 2 L amino acid/glycerol solution, 1 x 2 L Extraneal, and at least 1 x 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.

Characteristics of hypotension-prone haemodialysis patients: is there a critical relative blood volume?

BACKGROUND: Intradialytic morbid events (IME, mostly hypotension) mainly due to ultrafiltration-induced hypovolaemia still are the most frequent complication during haemodialysis (HD). This study was performed to test the hypothesis that there is an individual critical relative blood volume (RBV(crit)) in IME-prone HD patients. METHODS: In this prospective international multicentre study, 60 IME-prone patients from nine dialysis centres were observed during up to 21 standard HD sessions without trial-specific intervention. The RBV was monitored continuously by an ultrasonic method (BVM; blood volume monitor). Also, the ultrafiltration rate was registered continuously. Blood pressure was measured at regular intervals, and more frequently during IME. All IME and specific therapeutic interventions were noted. RESULTS: In total, 537 IME, some with more than one symptom, were documented during 585 HD sessions. The occurrence of IME increased up to 10-fold from the start to the end of the HD session. RBV(crit) showed a wide inter-individual range, varying from 71 to 98%. However, the intra-individual RBV limit was relatively stable, with an SD of <5% in three-quarters of the patients. In patients with congestive heart failure, cardiac arrhythmia, advanced age, low ultrafiltration volume and low diastolic blood pressure, higher values of RBV(crit) were observed. While all correlations between RBV(crit) and patient characteristics alone were found to be of weak or medium strength, the combination of diastolic blood pressure, ultrafiltration volume and age resulted in a strong correlation with RBV(crit): the linear equation with these parameters allows an estimation of RBV(crit) in patients not yet monitored with a BVM. CONCLUSIONS: An individual RBV limit exists for nearly all patients. In most IME-prone patients, these RBV values were stable with only narrow variability, thus making it a useful indicator to mark the individual window of haemodynamic instabilities.