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ORIGINAL ARTICLES |
Department/Division of Nephrology, Centralsjukhuset,1 Karlstad; Universitetssjukhuset,2 Umeå; Universitetssjukhuset,3 Örebro; Falu Lasarett,4 Falun; Höglandsjukhuset Eksjöklinikerna,5 Eksjö; Kärnsjukhuset,7 Skövde; Universitetssjukhuset,8 Linköping; Sunderby Sjukhus,9 Luleå; Universitetssjukhuset,10 Lund; Department of Nephrology and Transplantation,12 Universitetssjukhuset MAS, Malmö; Department/Division of Nephrology, Karolinska Sjukhuset,13 Stockholm; Centrallasarettet,15 Växjö; Vrinnevisjukhuset,16 Norrköping, Sweden; Department of Nephrology, St. Lucas Andreas Ziekenhuis,6 Amsterdam; University Medical Centre Nijmegen,11 Nijmegen, The Netherlands; Clinic of Transplantation Immunology and Nephrology,14 University Hospital Basel, Basel, Switzerland; Clinical Research Department,17 Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany
Correspondence to: T. De los Ríos, Clinical Research, Research & Development, Fresenius Medical Care Deutschland GmbH, Daimlerstrasse 15, 61346 Bad Homburg, Germany. tatiana.de-los-rios{at}fmc-ag.com
Background: Novel peritoneal dialysis solutions are
characterized by a minimal content of glucose degradation products and a
neutral pH. Many studies have shown the biocompatibility of neutral
lactate-buffered solutions; however, until now, the effect of purely
bicarbonate-buffered solutions has not been intensively studied in
vivo. Methods: This study was an open label, prospective,
crossover multicenter trial to investigate the biocompatibility of a purely
bicarbonate-buffered solution (bicPDF) by measuring biocompatibility
parameters such as cancer antigen 125 (CA125) in peritoneal effluent. 55
patients were enrolled in the study. After a 2-week run-in phase, 53 patients
could be randomized into 2 groups, starting with either standard
lactate-buffered peritoneal dialysis fluid (SPDF) for 12 weeks (phase 1) and
then switching to bicPDF for 12 weeks (phase 2), or vice versa. Overnight
peritoneal effluents were collected at baseline and at the end of phases 1 and
2 and were tested for CA125, hyaluronic acid, vascular endothelial growth
factor (VEGF), tumor necrosis factor-alpha (TNF-
), interleukin 6
(IL-6), interferon gamma (IFN
), and transforming growth
factor-beta1 (TGF-β1). Total ultrafiltration and residual
renal function were also assessed. At the end of the study, pain during fluid
exchange and dwell was evaluated using special questionnaires. Results: 34 patients completed the study; 27 of them
provided data for analysis of the biocompatibility parameters. CA125 levels in
overnight effluent were significantly higher with bicPDF (61.9 ± 33.2
U/L) than with SPDF (18.6 ± 18.2 U/L, p < 0.001).
Hyaluronic acid levels were significantly lower after the use of bicPDF (185.0
± 119.6 ng/mL) than after SPDF (257.4 ± 174.0 ng/mL, p
= 0.013). Both TNF- and TGF-β1 showed higher levels with the use
of bicPDF than with SPDF. No differences were observed for IL-6, VEGF, or
IFN levels. We observed an improvement in the glomerular filtration
rate with the use of bicPDF but no differences were observed for total fluid
loss. Pain scores could be analyzed in 23 patients: there was no difference
between the solutions. Conclusions: The use of a purely bicarbonate-buffered
low-glucose degradation product solution significantly changes most of the
peritoneal effluent markers measured, suggesting an improvement in peritoneal
membrane integrity. Additionally, it seems to have a positive effect on
residual renal function.
KEY WORDS: Biocompatibility; cancer antigen 125; residual renal function; peritoneal dialysis fluids; purely bicarbonate buffered.
Received 30 May 2008; accepted 23 February 2009.
This article has been cited by other articles:
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  S. L.S. Fan SHOULD WE USE BIOCOMPATIBLE PD SOLUTIONS FOR ALL PATIENTS? Perit. Dial. Int., November 1, 2009; 29(6): 630 - 633. [Full Text] [PDF]
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