title: Effects of Conversion to a Bicarbonate/Lactate-Buffered, Neutral-pH, Low-GDP PD Regimen in Prevalent PD: A 2-Year Randomized Clinical Trial.
abstract: ♦ BACKGROUND: The use of pH-neutral peritoneal dialysis (PD) fluids low in glucose degradation products (GDP) may better preserve the peritoneal membrane and have fewer systemic effects. The effects of conversion from conventional to neutral-pH, low-GDP PD fluids in prevalent patients are unclear. Few studies on the role of neutral-pH, low-GDP PD have studied residual renal function, ultrafiltration, peritonitis incidence and technique failure, transport characteristics, and local and systemic markers of inflammation in prevalent PD patients. ♦ METHODS: In a multi-center open-label randomized clinical trial (RCT), we randomly assigned 40 of 78 stable continuous ambulatory PD (CAPD) and automated PD (APD) patients to treatment with bicarbonate/lactate, neutral-pH, low-GDP PD fluid (Physioneal; Baxter Healthcare Corporation, Deerfield, IL, USA) and compared them with 38 patients continuing their current standard lactate-buffered PD fluid (PDF) (Dianeal; Baxter Healthcare Corporation, Deerfield, IL, USA) during 2 years. Primary outcome was residual renal function (RRF) and ultrafiltration (UF) during peritoneal equilibration test (PET); peritonitis incidence was a secondary outcome. Furthermore, clinical parameters as well as several biomarkers in effluents and serum were measured. ♦ RESULTS: During follow-up, RRF did not differ between the groups. In the Physioneal group ultrafiltration (UF) during PET remained more or less stable (-20 mL [confidence interval (CI): -163.5 - 123.5 mL];p= 0.7 over 24 months), whereas it declined in the Dianeal group (-243 mL [CI: -376.6 to -109.4 mL];p< 0.0001 over 24 months), resulting in a difference of 233.7 mL [95% CI 41.0 - 425.5 mL];p= 0.017 between the groups at 24 months. The peritonitis rate was lower in the Physioneal group: adjusted odds ratio (OR) 0.38 (0.15 - 0.97)p= 0.043. No differences were observed between the 2 groups in peritoneal adequacy or transport characteristics nor effluent markers of local inflammation (cancer antigen [CA]125, hyaluronan [HA], vascular endothelial growth factor [VEGF], macrophage chemo-attractant protein [MCP]-1, HA and transforming growth factor [TGF]β-1). ♦ CONCLUSION: In prevalent PD patients, our study did not find a difference in RRF after conversion from conventional to neutral-pH, low-GDP PD fluids, although there is a possibility that the study was underpowered to detect a difference. Decline in UF during standardized PET was lower after 2 years in the Physioneal group.
authors.affiliation: VU University Medical Center, Department of Nephrology, Amsterdam, The Netherlands k.farhat@vumc.nl.|Spaarnegasthuis, Department of Internal Medicine, Hoofddorp, The Netherlands.
authors.forename: Karima
authors.initials: K
authors.lastname: Farhat
authors.affiliation: VU University Medical Center, Department of Nephrology, Amsterdam, The Netherlands.|Spaarnegasthuis, Department of Internal Medicine, Hoofddorp, The Netherlands.
authors.forename: Caroline E
authors.initials: CE
authors.lastname: Douma
authors.affiliation: VU University Medical Center, Department of Molecular Cell Biology and Immunology, Amsterdam, The Netherlands.
authors.forename: E
authors.initials: E
authors.lastname: Ferrantelli
authors.affiliation: VU University Medical Center, Department of Nephrology, Amsterdam, The Netherlands.
authors.forename: Pieter M
authors.initials: PM
authors.lastname: Ter Wee
authors.affiliation: VU University Medical Center, Department of Molecular Cell Biology and Immunology, Amsterdam, The Netherlands.
authors.forename: Robert H J
authors.initials: RHJ
authors.lastname: Beelen
authors.affiliation: VU University Medical Center, Department of Nephrology, Amsterdam, The Netherlands.
authors.forename: Frans J
authors.initials: FJ
authors.lastname: van Ittersum
mesh_terms: D002021:Buffers; D015314:Dialysis Solutions / Q000737:chemistry*; D005260:Female; D005500:Follow-Up Studies; D006153:Guanosine Diphosphate / Q000032:analysis*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D015994:Incidence; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D009930:Organic Chemicals / Q000494:pharmacology; D010531:Peritoneal Dialysis, Continuous Ambulatory / Q000379:methods*; D010537:Peritoneum; D010538:Peritonitis / Q000453:epidemiology; D011446:Prospective Studies; D013997:Time Factors
chemical_list: D002021:Buffers; D015314:Dialysis Solutions; D009930:Organic Chemicals; C488052:Physioneal 35; D006153:Guanosine Diphosphate
keywords: Peritoneal dialysis; biocompatibility; cytokines; peritoneal equilibrium test