Ultrapure dialysis fluid
- Nicholas Hoenich, PhD
Nicholas Hoenich, PhD
- Associate Member
- Institute of Cellular Medicine, Newcastle University
- Richard A Ward, PhD
Richard A Ward, PhD
- Professor of Medicine
- University of Louisville
Dialysis fluid is required to meet quality standards in order to protect hemodialysis patients from exposure to chemical and microbiologic contaminants [1-3]. Quality standards for dialysis fluid and the water used in its preparation have been published by national standards organizations based on international standards . Best practice guidelines covering those aspects of hemodialysis therapy have also been published [1,5-8].
The standards and practice guidelines are in broad agreement with respect to permitted levels of chemical contaminants. However, there are differences in the maximum allowable levels of bacteria and endotoxin. Lower bacterial levels are more commonly recommended in more recent standards and guidelines than in earlier publications. (See 'National quality standards' below.)
The use of dialysis fluid of much higher microbiologic purity (called ultrapure dialysis fluid) than is required by some international and national standards may decrease inflammation and improve outcomes among chronic dialysis patients. The routine clinical use of ultrapure dialysis fluid is not required by regulation; however, as its production is technically and economically feasible in most dialysis facilities, standards and clinical practice guidelines recommend its use for all forms of hemodialysis [1,5,9-12].
Ultrapure dialysis fluid may also be a starting solution that is further filtered for use for "on-line" therapies such as on-line hemodiafiltration and hemofiltration . (See "Alternative renal replacement therapies in end-stage renal disease".)
This topic reviews methods of production and monitoring of ultrapure dialysis fluid and reviews studies that have examined the effect of ultrapure dialysis fluid on selected outcomes. A general overview of maintaining water quality for hemodialysis is presented separately. (See "Maintaining water quality for hemodialysis".)
Subscribers log in hereLiterature review current through: Jul 2017. | This topic last updated: Jul 26, 2016.References
- Section IV. Dialysis fluid purity. Nephrol Dial Transplant 2002; 17 Suppl 7:45.
- Ward RA. Worldwide water standards for hemodialysis. Hemodial Int 2007; 11:S18.
- International Organization for Standardization. Quality of dialysis fluid for hemodialysis and related therapies (ISO 11663:2014). Geneva, International Organization for Standardization, 2014.
- Ward RA. Worldwide guidelines for the preparation and quality management of dialysis fluid and their implementation. Blood Purif 2009; 27 Suppl 1:2.
- Kawanishi H, Masakane I, Tomo T. The new standard of fluids for hemodialysis in Japan. Blood Purif 2009; 27 Suppl 1:5.
- Pérez-García R, García Maset R, Gonzalez Parra E, et al. Guideline for dialysate quality of Spanish Society of Nephrology (second edition, 2015). Nefrologia 2016; 36:e1.
- Alloatti S, Bolasco P, Canavese C, et al. [Guidelines on water and solutions for dialysis. Italian Society of Nephrology]. G Ital Nefrol 2005; 22:246.
- UK Renal Association (RA) and Association of Renal Technologists (ART) guideline on water treatment facilities, dialysis water and dialysis fluid quality for haemodialysis and related therapies. January 2016. http://www.renal.org/guidelines/joint-guidelines#sthash.a0JOx0E1.dpbs (Accessed on July 24, 2016).
- Coulliette AD, Arduino MJ. Hemodialysis and water quality. Semin Dial 2013; 26:427.
- Canaud B, Lertdumrongluk P. Ultrapure dialysis fluid: a new standard for contemporary hemodialysis. Nephrourol Mon 2012; 4:519.
- Ronco C. Hemodiafiltration: Technical and Clinical Issues. Blood Purif 2015; 40 Suppl 1:2.
- International Organization for Standardization. Guidance for the preparation and quality management of fluids for hemodialysis and related therapies (ISO 23500:2014). Geneva, International Organization for Standardization, 2014.
- Ledebo I, Blankestijn PJ. Haemodiafiltration-optimal efficiency and safety. NDT Plus 2010; 3:8.
- Conditions for Coverage for End-Stage Renal Disease Facilities. 42 CFR Part 494.40. Department of Human and Health Services, Centers for Medicare and Medicaid Services, Baltimore, 2008.
- Association for the Advancement of Medical Instrumentation. Dialysate for hemodialysis (ANSI/AAMI RD52:2004). Arlington, VA, Association for the Advancement of Medical Instrumentation, 2004.
- Association for the Advancement of Medical Instrumentation. Quality of dialysis fluid for hemodialysis fluid and related therapies ANSI/AAMI 11663:2014. Association for the Advancement of Medical Instrumentation, Arlington, VA, 2014.
- Lonnemann G, Mahiout A, Schindler R, Colton CK. Pyrogen retention by the polyamide membranes. Contrib Nephrol 1992; 96:47.
- Bommer J, Becker KP, Urbaschek R. Potential transfer of endotoxin across high-flux polysulfone membranes. J Am Soc Nephrol 1996; 7:883.
- Schindler R, Beck W, Deppisch R, et al. Short bacterial DNA fragments: detection in dialysate and induction of cytokines. J Am Soc Nephrol 2004; 15:3207.
- Tao X, Hoenich N, Handelman SK, et al. Transfer of low-molecular weight single-stranded DNA through the membrane of a high-flux dialyzer. Int J Artif Organs 2014; 37:529.
- Schiavano GF, Parlani L, Sisti M, et al. Occurrence of fungi in dialysis water and dialysate from eight haemodialysis units in central Italy. J Hosp Infect 2014; 86:194.
- Bossola M, Sanguinetti M, Scribano D, et al. Circulating bacterial-derived DNA fragments and markers of inflammation in chronic hemodialysis patients. Clin J Am Soc Nephrol 2009; 4:379.
- Glorieux G, Neirynck N, Veys N, Vanholder R. Dialysis water and fluid purity: more than endotoxin. Nephrol Dial Transplant 2012; 27:4010.
- Tsuchida K, Takemoto Y, Yamagami S, et al. Detection of peptidoglycan and endotoxin in dialysate, using silkworm larvae plasma and limulus amebocyte lysate methods. Nephron 1997; 75:438.
- Stenvinkel P, Alvestrand A. Inflammation in end-stage renal disease: sources, consequences, and therapy. Semin Dial 2002; 15:329.
- Pecoits-Filho R, Heimbürger O, Bárány P, et al. Associations between circulating inflammatory markers and residual renal function in CRF patients. Am J Kidney Dis 2003; 41:1212.
- Oberg BP, McMenamin E, Lucas FL, et al. Increased prevalence of oxidant stress and inflammation in patients with moderate to severe chronic kidney disease. Kidney Int 2004; 65:1009.
- Yao Q, Lindholm B, Stenvinkel P. Inflammation as a cause of malnutrition, atherosclerotic cardiovascular disease, and poor outcome in hemodialysis patients. Hemodial Int 2004; 8:118.
- Lonnemann G. Chronic inflammation in hemodialysis: the role of contaminated dialysate. Blood Purif 2000; 18:214.
- Lonnemann G. When good water goes bad: how it happens, clinical consequences and possible solutions. Blood Purif 2004; 22:124.
- Sitter T, Bergner A, Schiffl H. Dialysate related cytokine induction and response to recombinant human erythropoietin in haemodialysis patients. Nephrol Dial Transplant 2000; 15:1207.
- Schiffl H, Lang SM, Stratakis D, Fischer R. Effects of ultrapure dialysis fluid on nutritional status and inflammatory parameters. Nephrol Dial Transplant 2001; 16:1863.
- Matsuhashi N, Yoshioka T. Endotoxin-free dialysate improves response to erythropoietin in hemodialysis patients. Nephron 2002; 92:601.
- Arizono K, Nomura K, Motoyama T, et al. Use of ultrapure dialysate in reduction of chronic inflammation during hemodialysis. Blood Purif 2004; 22 Suppl 2:26.
- Hsu PY, Lin CL, Yu CC, et al. Ultrapure dialysate improves iron utilization and erythropoietin response in chronic hemodialysis patients - a prospective cross-over study. J Nephrol 2004; 17:693.
- Furuya R, Kumagai H, Takahashi M, et al. Ultrapure dialysate reduces plasma levels of beta2-microglobulin and pentosidine in hemodialysis patients. Blood Purif 2005; 23:311.
- Molina M, Navarro MJ, Palacios ME, et al. [Importance of ultrapure dialysis liquid in response to the treatment of renal anaemia with darbepoetin in patients receiving haemodialysis]. Nefrologia 2007; 27:196.
- Go I, Takemoto Y, Tsuchida K, et al. The effect of ultrapure dialysate on improving renal anemia. Osaka City Med J 2007; 53:17.
- Susantitaphong P, Riella C, Jaber BL. Effect of ultrapure dialysate on markers of inflammation, oxidative stress, nutrition and anemia parameters: a meta-analysis. Nephrol Dial Transplant 2013; 28:438.
- Handelman GJ, Megdal PA, Handelman SK. Bacterial DNA in water and dialysate: detection and significance for patient outcomes. Blood Purif 2009; 27:81.
- Wanner C, Drechsler C, Krane V. C-reactive protein and uremia. Semin Dial 2009; 22:438.
- Ward RA. Ultrapure dialysate. Semin Dial 2004; 17:489.
- Honda H, Qureshi AR, Heimbürger O, et al. Serum albumin, C-reactive protein, interleukin 6, and fetuin a as predictors of malnutrition, cardiovascular disease, and mortality in patients with ESRD. Am J Kidney Dis 2006; 47:139.
- Zhang W, He J, Zhang F, et al. Prognostic role of C-reactive protein and interleukin-6 in dialysis patients: a systematic review and meta-analysis. J Nephrol 2013; 26:243.
- Owen WF, Lowrie EG. C-reactive protein as an outcome predictor for maintenance hemodialysis patients. Kidney Int 1998; 54:627.
- Herbelin A, Ureña P, Nguyen AT, et al. Elevated circulating levels of interleukin-6 in patients with chronic renal failure. Kidney Int 1991; 39:954.
- Asci G, Tz H, Ozkahya M, et al. The impact of membrane permeability and dialysate purity on cardiovascular outcomes. J Am Soc Nephrol 2013; 24:1014.
- Rahmati MA, Homel P, Hoenich NA, et al. The role of improved water quality on inflammatory markers in patients undergoing regular dialysis. Int J Artif Organs 2004; 27:723.
- Lamas JM, Alonso M, Sastre F, et al. Ultrapure dialysate and inflammatory response in haemodialysis evaluated by darbepoetin requirements--a randomized study. Nephrol Dial Transplant 2006; 21:2851.
- Ouseph R, Jones S, Dhananjaya N, Ward RA. Use of ultrafiltered dialysate is associated with improvements in haemodialysis-associated morbidity in patients treated with reused dialysers. Nephrol Dial Transplant 2007; 22:2269.
- Lederer SR, Schiffl H. Ultrapure dialysis fluid lowers the cardiovascular morbidity in patients on maintenance hemodialysis by reducing continuous microinflammation. Nephron 2002; 91:452.
- Schiffl H, Fischer R, Lang SM, Mangel E. Clinical manifestations of AB-amyloidosis: effects of biocompatibility and flux. Nephrol Dial Transplant 2000; 15:840.
- Miyata T, Taneda S, Kawai R, et al. Identification of pentosidine as a native structure for advanced glycation end products in beta-2-microglobulin-containing amyloid fibrils in patients with dialysis-related amyloidosis. Proc Natl Acad Sci U S A 1996; 93:2353.
- Izuhara Y, Miyata T, Saito K, et al. Ultrapure dialysate decreases plasma pentosidine, a marker of "carbonyl stress". Am J Kidney Dis 2004; 43:1024.
- Hasegawa T, Nakai S, Masakane I, et al. Dialysis fluid endotoxin level and mortality in maintenance hemodialysis: a nationwide cohort study. Am J Kidney Dis 2015; 65:899.
- Honda H, Suzuki H, Hosaka N, et al. Ultrapure dialysate influences serum myeloperoxidase levels and lipid metabolism. Blood Purif 2009; 28:29.
- Schiffl H, Lang SM. Effects of dialysis purity on uremic dyslipidemia. Ther Apher Dial 2010; 14:5.
- Schiffl H, Lang SM, Fischer R. Ultrapure dialysis fluid slows loss of residual renal function in new dialysis patients. Nephrol Dial Transplant 2002; 17:1814.
- Schiffl H, Wendinger H, Lang SM. Ultrapure dialysis fluid and response to hepatitis B vaccine. Nephron 2002; 91:530.
- NATIONAL QUALITY STANDARDS
- PRODUCTION OF ULTRAPURE DIALYSIS FLUID
- MONITORING DIALYSIS FLUID QUALITY
- CLINICAL BENEFITS OF ULTRAPURE DIALYSIS FLUID
- Anemia correction
- Beta2-microglobulin and dialysis-related amyloid
- Nutritional status
- Other clinical outcomes
- SUMMARY AND RECOMMENDATIONS