A combination of biocompatible peritoneal dialysis solutions and residual renal function, peritoneal transport, and inflammation markers: a randomized clinical trial.

BACKGROUND: The benefits of biocompatible peritoneal dialysis (PD) fluids, particularly for residual renal function (RRF), are controversial. Moreover, the clinical effects of a PD regimen consisting of different biocompatible PD fluids have not been fully established. STUDY DESIGN: Prospective, randomized, controlled, open-label study. SETTING & PARTICIPANTS: Patients with end-stage kidney disease newly started on continuous ambulatory PD therapy (N = 150). INTERVENTION: A 12-month intervention with 3 biocompatible PD fluids (a neutral-pH, low glucose degradation product, 1.5% glucose solution; a solution with 1.1% amino acid; and a fluid with 7.5% icodextrin) or conventional PD fluid. OUTCOMES: The primary outcome was change in RRF and daily urine volume. Secondary outcomes were peritoneal transport and inflammation markers. MEASUREMENTS: RRF, daily urine volume, serum and dialysate cytokine levels. RESULTS: RRF(3.24 ± 1.98 vs 2.88 ± 2.43 mL/min/1.73 m(2); P = 0.9) and rate of decline in RRF (-0.76 ± 1.77 vs -0.91 ± 1.92 mL/min/1.73 m(2) per year; P = 0.6) did not differ between the biocompatible- and conventional-PD-fluid groups. However, patients using the biocompatible PD fluids had better preservation of daily urine volume (959 ± 515 vs 798 ± 615 mL/d in the conventional group, P = 0.02 by comparison of difference in overall change by repeated-measures analysis of variance). Their dialysate-plasma creatinine ratio at 4 hours was higher at 12 months (0.78 ± 0.13 vs 0.68 ± 0.12; P = 0.01 for comparison of the difference in overall change by repeated-measures analysis of variance). They also had significantly higher serum levels of adiponectin and overnight spent dialysate levels of cancer antigen 125, adiponectin, and interleukin 6 (IL-6). No differences between the 2 groups were observed for serum C-reactive protein and IL-6 levels. LIMITATIONS: Unblinded, relatively short follow-up; no formal sample-size calculations. CONCLUSIONS: Use of a combination of 3 biocompatible PD fluids for 12 months compared with conventional PD fluid did not affect RRF, but was associated with better preservation of daily urine volume. The biocompatible PD fluids also lead to changes in small-solute transport and an increase in dialysate cancer antigen 125, IL-6, adiponectin, and systemic adiponectin levels, but have no effect on systemic inflammatory response. The clinical significance of these changes, while of great interest, remains to be determined by further studies.

Studying the effects of new peritoneal dialysis solutions on the peritoneum.

BACKGROUND: Compelling data underscore the bioincompatible nature of glucose-based peritoneal dialysis (PD) solutions and their detrimental effects on peritoneal physiology and morphology. New PD solutions have been formulated to tackle common clinical problems such as inadequate ultrafiltration or malnutrition, and to improve biocompatibility-the latter aimed at preserving the structural and functional integrity of the peritoneum and reducing adverse systemic effects on the patient. METHODS: This article reviews the factors in PD fluids that alter normal peritoneal anatomy and physiology, and the data that illustrate approaches to investigating the local and systemic biocompatibility of new PD solutions. RESULTS: Chronic exposure of the peritoneal membrane to glucose-based PD solutions results in denudation of the mesothelium, thickened submesothelium, and hyalinization of the vasculature, often resulting in reduced or lost solute and water clearance. Data from in vitro or animal experiments and clinical studies have shown improved biocompatibility profiles with new PD solutions that are glucose-free (that is, dialysates with amino acids or icodextrin), bicarbonate-buffered, or compartmentalized during heat sterilization to reduce levels of glucose degradation products. Improved biocompatibility is denoted by reduced induction of proinflammatory, profibrotic, or angiogenic growth factors in mesothelial cells and macrophages, or by less perturbation of leukocyte phagocytic function. CONCLUSIONS: Data from in vitro and animal experiments show more favorable biocompatibility profiles with new PD fluids than with glucose-based dialysates. Clinical studies are ongoing to assess the impact of the new PD fluids on peritoneal function, morbidity, and mortality.

Pilot study of pegylated interferon-alpha 2a in dialysis patients with chronic hepatitis C virus infection.

AIM: Pegylated interferon (PEG-IFN) combined with ribavirin is recommended for the treatment of chronic hepatitis C virus (HCV) infection in patients without renal failure. The optimal treatment of hepatitis C in dialysis patients remains to be established. A high incidence of adverse effects has been observed with conventional interferon and PEG-IFN alpha-2b in dialysis patients. METHODS: We conducted a prospective study to investigate the tolerability and efficacy of PEG-IFN alpha-2a (135 microg weekly for 48 weeks) in six dialysis patients with chronic HCV infection. RESULTS: Two patients completed 48 weeks of treatment. Treatment was stopped in three patients (beyond 24 weeks) when they developed unrelated complications, and stopped in one patient due to failure of viral clearance. None required treatment discontinuation due to adverse effects, and PEG-IFN alpha-2a was subjectively well tolerated. Marrow suppression with mild anaemia, leucopenia, or thrombocytopenia remained common. Two patients (infected with genotypes 3a and 1b, respectively) had sustained virological response. CONCLUSIONS: Results from this pilot study showed that PEG-IFN alpha-2a appeared relatively well tolerated in dialysis patients with chronic HCV infection, and about one-third of patients could achieve sustained virological response.