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BIOCOMPATIBILITY AND TOLERABILITY OF A PURELY BICARBONATE-BUFFERED PERITONEAL DIALYSIS SOLUTION

Weiss, Lars; Stegmayr, Bernd; Malmsten, Gudrun; Tejde, Mattias; Hadimeri, Henrik; Siegert, Carl E.; Ahlmen, Jarl; Larsson, Rutger; Ingman, Bo and Simonsen, Ole LU , et al. (2009) In Peritoneal Dialysis International 29(6). p.647-655
Abstract
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... (More)
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-alpha), interleukin 6 (IL-6), interferon gamma (IFN gamma), and transforming growth factor-beta 1 (TGF-beta 1). 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-alpha and TGF-beta 1 showed higher levels with the use of bicPDF than with SPDF. No differences were observed for IL-6, VEGF, or IFN gamma 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. (Less)
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subject
keywords
peritoneal dialysis fluids, residual renal function, Biocompatibility, cancer antigen 125, purely bicarbonate buffered
in
Peritoneal Dialysis International
volume
29
issue
6
pages
647 - 655
publisher
Multimed Inc.
external identifiers
  • wos:000271713900009
  • scopus:77954337529
ISSN
1718-4304
language
English
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yes
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66268df1-d530-4bcf-959e-f5246da1239b (old id 1518742)
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http://www.pdiconnect.com/cgi/content/abstract/29/6/647
date added to LUP
2009-12-28 15:03:29
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2017-09-03 04:09:09
@article{66268df1-d530-4bcf-959e-f5246da1239b,
  abstract     = {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-alpha), interleukin 6 (IL-6), interferon gamma (IFN gamma), and transforming growth factor-beta 1 (TGF-beta 1). 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 &lt; 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-alpha and TGF-beta 1 showed higher levels with the use of bicPDF than with SPDF. No differences were observed for IL-6, VEGF, or IFN gamma 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.},
  author       = {Weiss, Lars and Stegmayr, Bernd and Malmsten, Gudrun and Tejde, Mattias and Hadimeri, Henrik and Siegert, Carl E. and Ahlmen, Jarl and Larsson, Rutger and Ingman, Bo and Simonsen, Ole and van Hamersvelt, Henk W. and Johansson, Ann C and Hylander, Britta and Mayr, Michael and Nilsson, Per-Henrik and Andersson, Per O. and De los Rios, Tatiana},
  issn         = {1718-4304},
  keyword      = {peritoneal dialysis fluids,residual renal function,Biocompatibility,cancer antigen 125,purely bicarbonate buffered},
  language     = {eng},
  number       = {6},
  pages        = {647--655},
  publisher    = {Multimed Inc.},
  series       = {Peritoneal Dialysis International},
  title        = {BIOCOMPATIBILITY AND TOLERABILITY OF A PURELY BICARBONATE-BUFFERED PERITONEAL DIALYSIS SOLUTION},
  volume       = {29},
  year         = {2009},
}