water and dialysis fluids - dccdn.de€¦ · this book “water and dialysis fluids, ... the former...

Water and Dialysis FluidsA QUALITY MANAGEMENT GUIDE

Carlo Boccato, David Evans, Rui Lucena and Jörg Vienken

Good Dialysis Practice

Series Editor: Jörg Vienken

Water and Dialysis FluidsA QUALITY MANAGEMENT GUIDE


Good Dialysis Practice

Library of Congress Cataloging-in-Publication Data

Bibliographic information publisled by “Die Deutsche Bibliothek”

(Good Dialysis Practice Vol 8)

ISBN - 978-3-95853-111-6

This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically

the rights of translation, reprinting, reuse of ilustrations, recitation, broadcasting, reprodution on microfilms or in other

ways, and storage in data banks. The use of registred names, trademarks, etc. in this publication does not imply, even in the

absence of a specific statement, that such names are exempt from the relevant protective laws and regulatin and therefore

free for general use.

The authors and the publisher of this volume have taken care that the information and recommendations contained herein

are accurate and compatible with the standarts generally accepted at the time of publication.However, it cannot be ensured

that all the information given is od adequate accuracy for all possible applications. The publisher disclaims any liability, loss,

or damage incurred as consequence, directly or indirectly, of the use and application of any of the contents of this volume.

©2015 Pabst Science Publishers, 49525 Lengerich, Germany

Printing: Ten Brink, 7944 KC Meppel, The Netherlands

Book Pagination: Gonçalo Dias Santos ([email protected])

Ilustrations: Gonçalo Dias Santos

Good Dialysis Practice Series Editor: Jörg Vienken

Vol 8

In 1998, the first book of the series „Good Dialysis Practice“ entitled “Water quality in Hemodialysis” was published by Elisabeth Bonnie-Schorn, Aileen Grassmann, Ingrid Uhlenbusch-Körwer, Christoph Weber and Jörg Vienken. These authors successfully provided facts, data and figures on all aspects of water quality. In the following years, this book has provoked many reflections and measures on this important issue of dialysis care. Some details of this book have even found entrance into actual national guidelines on dialysis water quality in Europe.

This book “Water and Dialysis Fluids, A Quality Management Guide“, considerably profits from the content of their textbook and the experience of those authors. For the benefit of future readers, some of that original information is used within this book.

It is the privilege of the authors of “Water and Dialysis Fluids, A Quality Management Guide“, to express their heartfelt thanks to the authors, of “Good Dialysis Practice, Volume 1”.

Bad Homburg, September 2015


Acknowledgement

Water and Dialysis FluidsA QUALITY MANAGEMENT GUIDE 07

Quality of water and dialysis fluids

“If you know the enemy and know yourself, you need not to fear the results of a hundred battles.

If you know yourself, but not the enemy, for every victory gained, you will also suffer a defeat!”

Sun Tzu, China 500 b.c.


Water is an essential component of renal replacement therapy by dialysis. Water serves as a solvent to electrolytic concentrates for the preparation of dialysis fluids. The proportioning haemodialysis machine ensure a continuous and precise mixing of electrolytes and water to achieve the prescribed electrolytes composition. Dialysis fluid is the exchange media with patient blood that ensures solutes transport from the “internal milieu” (patient) to the “external milieu” (waste) through a thin (<20 μm) semipermeable dialyzer membrane. In that sense, dialysis fluid may be considered as an extension of the extracellular compartment of a dialysis patient exposing the dialysis patient to biohazards. Acknowledging the fact that 120 to 150 litres of dialysis fluid circulate against blood three times a week, indicates that the blood of dialysis patients is exposed to 30 to 40 times more water than the general population. In addition, anuric dialysis patients are exposed for long periods of time and have, by the way considerable cumulative time exposure that needs to be considered in the risk assessment. Based on these risk considerations, one must recognize that dialysis water purity must comply with higher standards than deionized water [1]. Contemporary dialysis therapies have contributed significantly to an increase in risks associated to dialysis water. Highly permeable membranes, used to remove middle and large uremic retention solutes, favour transmembrane passage of dialysis fluid contaminants. Ultrafiltration modules and capillary filters induce a backtransport phenomenon of dialysis fluid contaminants. Highly efficient dialysis modalities, imposing high solute mass transfer, also enhance the transport of dialysis fluid contaminants to the blood stream of the patients. Online convective dialysis modalities (e.g., haemodiafiltration) further enhance convective transport (20-30 litres/session), while replacing ultrafiltrate by direct IV infusion of online prepared substitution fluid. This increases the hazards related to dialysis fluid contamination.

Interestingly, dialysis water purity requirements have evolved over the time to satisfy new therapeutic objectives in the renal replacement therapy field. In the seventies, water purification was essentially focused on removing macro-contaminants, colloid particles, calcium, magnesium and chlorine ions as well as substances with potential acute toxic effects. At that time, the main concern was to prevent the occurrence of the “hard water syndrome” and pyrogenic reactions. Water treatment systems were relatively simple, with microfilters and softeners. In the eighties, water purification systems were refined and completed with the introduction and the general inclusion, of activated carbon filters and reverse osmosis modules or deionizers (mixed beds), to remove metal contaminants (e.g., aluminium), agricultural and industrial pollutants, chlorine and chloramines used as sanitizers of drinking water. In the 1990s, water distribution systems now considered as an integral part of water treatment systems, were redesigned to ensure delivery of pure water to the dialysis machines, aiming to clean water from all potential chemical contaminants

Dialysis water and dialysis fluid purity:an evolving concept calling for new standards

Foreword


Water and Dialysis FluidsA QUALITY MANAGEMENT GUIDE12

and achieve a low microbial contamination level. This dialysis fluid purity grade was required to minimize hazards associated with new dialysis conditions that included high-flux capillary dialysers, bicarbonate buffer and fluid balancing devices [1, 2].Since the last two decades a new water purity grade was strongly recommended, namely dialysis water, defined as highly chemically purified with low microbial content. Water treatment systems consisting of a pre-treatment section, reverse osmosis module, a water distribution system loop and strict hygienic rules were required to comply with this new target. Dialysis water and ultrapure dialysis fluids were established as a prerequisite for online convective therapies (e.g. haemodiafiltration), to improve biocompatibility of the dialysis system and to reduce inflammation profile of the dialysis patients, and further, to anticipate new dialysis options (automatic priming and flushing, IV bolus e.g. to compensate for hypovolemia) [3, 4]. Ultrapure dialysis fluid is now widely accepted as a new standard therapy in modern haemodialysis therapy [5].

Thanks to the extensive and collaborative work of Carlo Boccato, David Evans, Rui Lucena and Jörg Vienken, the former book entitled “Water Quality in Hemodialysis” authored by E.Bonnie-Schorn, A.Grassmann, I.Uhlenbusch-Koerwer and J.Vienken in 1998 has been brought to you in a completely revised version. This book now provides, in a comprehensive and well documented fashion, medical rationale supporting the use of high grade water and dialysis fluid purity, several engineering water treatment options, water delivery and filtering systems, monitoring and quality control assurance process, maintenance of water treatment system and regulatory aspects. This book represents indisputably the “state of the art” in terms of dialysis water and dialysis fluid purity that should become the desk reference book for all haemodialysis centres and staff involved in the field of renal replacement therapy.

Professor Bernard Canaud, MDChairman of Medical Board EMEALA, Fresenius Medical Care, Bad Homburg, GermanyEmeritus Professor of Nephrology, Montpellier University I, UFR Medicine, Montpellier, France

References1. Mion, CM, Canaud B, Garred LJ, Stec F, Nguyen QV. Sterile and pyrogen-free bicarbonate dialysate: a necessity for hemodialysis today. Adv Nephrol Necker Hosp, 19:275-314 (1990)2. Martin K, Laydet E, Canaud B. Design and technical adjustment of a water treatment system: 15 years of experience.Adv Ren Replace Ther, 10:122-32 (2003)3. Canaud B.Changing paradigms of renal replacement therapy in chronic kidney disease patients: ultrapure dialysis fluid and high-efficiency hemodiafiltration for all?Kidney Int, 76:591-593 (2009)4. Canaud B, Granger-Vallée A. Should ultrapure dialysate be part of standard therapy in hemodialysis?Semin Dial, 24:426-427 (2011)5. Canaud B, Lertdumrongluk P. Ultrapure dialysis fluid: a new standard for contemporary hemodialysis.Nephrourol Mon, 4:519-23 (2012)

07

11

17

19

23

23

28

29

30

33

36

38

38

38

40

43

45

49

50

52

61

64

78

85

88

89

92

94

100

100

102

104

110

121

121

122

125

126

128

130

23

89

110

121

122

125

28

33

36

45

50

Water and Dialysis Fluids

Table of Contents

Acknowledgement

Foreword

1. Introduction

2. Haemodialysis water history – Milestones

3. Haemodialysis and its basic principles

3.1 Haemodialysis

3.2 Haemodialysis membranes

3.2.1 The ultrafiltration coefficient

3.2.2 Dialyser classification and dialyzer properties

3.3 Solute transport across dialysis membranes

3.4 Transport of contaminants across dialysis membranes

3.4.1 Backtransport, internal filtration, backdiffusion and backfiltration

3.4.2 Evidence for back transport of microbial contaminants

3.4.3 Safety aspects based on chemical composition of membranes

3.4.4 Evidence for the transfer of microbial contaminants across the dialysis

membrane by means of backtransport

3.4.5 Safety aspects based on chemical membrane composition

3.5 References

4. Nature and consequences of water and dialysis fluid contamination

4.1 Chemical contamination

4.1.1 Contaminants with documented toxicity in haemodialysis

4.1.2 Deviations of electrolytes normally included in dialysis fluids

4.1.3 Inorganic trace elements

4.1.4 Organic compounds, pesticides and chemicals of emerging concern

4.1.5 Disinfectants, preservatives and by-products

4.1.6 Radionuclides

4.2 Microbial contamination

4.2.1 Microbial contamination in dialysis water and dialysis fluids

4.2.2 Derivatives of microbial contaminants and their biological activity

4.2.3 Clinical consequences of microbial contamination

4.2.3.1 Short-term consequences

4.2.3.2 Long-term consequences

4.2.4 Biofilm and biofouling

4.3 References

5. Dialysis water, concentrates and dialysis fluids standards

5.1 Rationale behind standards

5.2 Dialysis fluids standards

5.3 International standards

5.3.1 Water chemical quality standards

5.3.1.1 Discussion on inorganic quality standards

5.3.1.2 Discussion on organic quality standards



5.3.2 Concentrates and dialysis fluids chemical quality standards

5.3.3 Water and dialysis fluids microbial quality standards

5.4 Compliance to the standards

5.4.1 Normative frame

5.4.2 Evidence-based criteria: regulate what is really affecting the patient’s health

5.4.3 Efficiency-based criteria: the best quality achievable with sustainable costs

5.5 References

6. System selection criteria, design and technical configuration

6.1 Overview of technologies and purification processes

6.2 Water treatment system

6.2.1 Pre-treatment

6.2.1.1 Feed water supply

6.2.1.2 Temperature blending / tempering valve

6.2.1.3 Feed water storage tank

6.2.1.4 Chemical injection systems

6.2.1.5 Multimedia / Sediment filter

6.2.1.6 Cartridge filters

6.2.1.7 Ion exchangers

6.2.1.8 Activated carbon filters

6.2.2 Primary and secondary treatment

6.2.2.1 Primary treatment - Reverse Osmosis

6.2.2.2 Secondary treatment

6.2.3 Dialysis water distribution

6.2.4 Disinfection systems

6.3 Concentrates systems

6.3.1 In-house concentrate preparation

6.3.2 Concentrate distribution system

6.4 Media supply

6.5 Point of use filtration (POU)

6.6 System design and technical considerations

6.6.1 Architectural and installation considerations

6.6.2 Materials selection

6.6.3 Installation procedures and documentation

6.7 System selection criteria

6.7.1 Safety considerations

6.7.2 Financial considerations

6.8 References

7. Validation of water treatment, concentrates and dialysis fluid delivery systems

7.1 Validation

7.2 Validation steps

7.2.1 The Validation plan

7.2.2 Installation Qualification (IQ)

7.2.3 Operational Qualification (OQ)

130

132

134

134

134

135

136

139

139

144

146

147

147

148

149

150

151

151

154

157

158

167

172

174

177

178

180

181

182

182

183

186

187

188

188

190

192

193

195

196

197

198

198

Water and Dialysis FluidsTable of Contents


7.2.4 Performance Qualification (PQ)

7.3 Validation and re-validation

7.4 Different approaches to validation

7.5 Validation documentation

7.6 References

8. Water, concentrates and dialysis fluids monitoring

8.1 Monitoring plan: how to monitor a validated system

8.2 Methodology

8.2.1 Online and offline monitoring

8.2.2 Sampling frequency

8.3 Chemical quality monitoring

8.3.1 Sampling

8.3.2 Assay methods

8.4 Microbial quality monitoring

8.4.1 Sampling

8.4.2 Assay methods and comparison of different techniques

8.4.3 Evaluation of microbial monitoring results and relevant (corrective) actions

8.5 The importance of trend analyses

8.6 Monitoring documentation

8.7 References

9. System maintenance

9.1 Approaches to maintenance

9.2 Maintenance documentation

9.3 References

10. Environmental aspects

10.1 Reduction of water consumption

10.2 Reduction of electric energy consumption

10.3 Reduction of externalities

10.4 References

11. Responsibilities and training

11.1 System validation, monitoring and maintenance responsibilities

11.2 Training activities

11.3 Interface with water supplier

11.4 References

12. Index

8.1 Monitoring plan: how to monitor a validated system

8.2 Methodology

8.3 Chemical quality monitoring

8.5 The importance of trend analyses

9.1 Approaches to maintenance

10.1 Reduction of water consumption

7.3 Validation and re-validation

11.1 System validation, monitoring and maintenance responsibilities

8.6 Monitoring documentation

8.7 References

9.2 Maintenance documentation

9.3 References

10.2 Reduction of electric energy consumption

7.4 Different approaches to validation

11.2 Training activities

10.3 Reduction of externalities

7.5 Validation documentation

10.4 References

7.6 References

11.3 Interface with water supplier

11.4 References

8.4 Microbial quality monitoring

199

200

201

202

203

205

205

206

208

210

210

211

213

215

215

218

226

229

229

230

231

232

237

237

239

240

244

245

246

247

247

249

250

250

251

Water and Dialysis FluidsTable of Contents

Water is ubiquitous. About 1.400.000.000 km³ are present on Earth. 70% of all water is present in creeks, rivers and oceans. However, only a very small portion of this huge amount, about 35 million km³, less than 1%, is fresh water, whereby the major part (80%) is fixed in the polar regions and currently not accessible.

7.1 million people currently live on earth, and surprisingly 89% have access to clean water in 2012 compared to 49% in 1990. These figures are based on a joint report of both, the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF) from May 2014 [1]. Hygiene associated to water, however still represents a matter of concern. 2.5 billion people don´t have access to sanitary facilities. The WHO / UNICEF report further highlights a narrowing disparity in access to better sanitation between rural and urban areas.

In the future, the request for clean water will rise by nearly 50% from 4,500 billion m³ in 2010 to 6,900 billion m³ in 2030 [1], based on the increase in the world´s population. Whether these demands can be met, is still a matter of debate.

These conditions also affect clinical haemodialysis. Haemodialysis therapy needs water too. It is needed for the preparation of dialysis fluids or substitution fluids, e.g. in haemodiafiltration or haemofiltration, or for rinsing a dialyzer prior to use. For all these applications, adequate water quality is mandatory. Current opinions among nephrologists indicate that water quality is even more important for the long term clinical success of haemodialysis therapy than the biocompatibility of dialysis membranes.

In 1998, the book entitled “Water Quality in Hemodialysis” was published [2]. The figure of about 10.000 printed copies, issued in three languages, has proven its popularity all around the world. It has become the sourcebook for persons in charge of directives for water quality in haemodialysis or for those responsible for dialysis water standards.Since 1998, relevant new investigations on effects related to water quality have been published. New international standards on dialysis water are available since 2009, such as the ISO norms:

ISO 11663 Quality of dialysis fluid for haemodialysis and related therapies; ISO 13958 Concentrates for haemodialysis and related therapies; ISO 13959 Water for dialysis and related therapies; ISO 26722 Water treatment equipment for haemodialysis and related therapies; ISO 23500 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies.


1Introduction


Further, dialytic therapies, such as haemodiafiltration (HDF) or high volume haemodiafiltration, have become popular due to their improved performance followed by a better patient survival [3]. Dialysis modes, such as HDF, need large volumes of substitution fluids that of course, have to be prepared from water of appropriate quality level (dialysis water).

As a consequence, a completely revised new version of the Water Book “Water Quality in Hemodialysis” has been compiled in order to summarize new findings on water quality and to provide information on the new available standards and norms. Last but not least, recommendations on how to deal with the water issue in haemodialysis are given, based on the technical and scientific experience of the authors. The authors represent a group of four specialists with proven track records and experience. This updated edition has been compiled to provide independent information and guidance based on current knowledge with an international perspective.

As already mentioned in the preface of the first edition, the authors hope that this book may serve as a vehicle for a better understanding of the background and problems of dialysis fluid quality and management. Of course, any comments and suggestions for improvement are desired and welcomed.

Bad Homburg, September 2015


References1. World Health Organization (WHO) / United Nations Children’s Fund (UNICEF) Progress on drinking water and sanitation: 2014 updateISBN: 978 92 4 150724 0; (May 2014)2. Bonnie-Schorn E, Grassmann A, Uhlenbusch-Körwer I, Weber C, Vienken JWater Quality in Hemodialysis. Pabst Scientific Publishers, Berlin (1998)3. Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Carreras J, Soler J, Torres F, Campistol J, Martinez-Castellao A; High efficiency postdilutional online haemodiafiltration reduces all-cause mortality in haemodialysis patients.J Am Soc Nephrol, 24:487-497 (2013)

1. IntroductionReferences

Water quality has not been an issue during the early days of dialysis therapy. Scientists, such as Thomas Graham [1] or Adolph Fick [2] were aware of the necessary concentration gradients but they did not yet consider any contaminants, neither of chemical nor of biological origin. Of course, at that time, few analytical tools were available and clinicians only considered patient survival and not clinical quality outcome. When dialysis technology advanced and developed from an experimental therapy to a standard in the years from 1945 to 1960, preparation of the dialysis fluid with appropriate electrolytes was of central importance. The washing bath of Willem Kolff´s “Rotating Drum” contained 100 L of fluid. Niels Alwall in Sweden prepared a stem solution for his cylinder artificial kidney in a 700 L tank that contained 7000 g Glucose, 4270 g NaCl, 1400 g NaHCO

3

and 57 g MgCl2. There is no need to say, that contaminants such as bacterial endotoxins were not

considered. An “auto-sterile” acetate buffer was also not in use at that time.

Water purification for dialysis was not widely recognized in the subsequent years. In the 1970s, the number of haemodialysis patients was small, they suffered from a series of side effects, such as aluminium related bone diseases, inflammation, hypotension, and severe itching, to name only a few. Patient mortality was also high and average life expectancy was seldom beyond three years. In the early 1970s, it was discovered that temporary bacteremia or pyrogenic reactions in patients during haemodialysis are associated with an excessively high bacterial count of Gram-negative bacteria and/or high endotoxin concentrations in the dialysis fluid [3].

Figure 1: Dialysis fluids are poured from a bucket into the completely open reservoir of a rotating-drum dialysis machine without precautions for contamination.Source: Picture from a movie on Dr. Kolffs first dialysis in 1945.


2Haemodialysis water history - milestones

First comments on consequences of a bacterial water contamination were, however, later reported in the 1980s from Dr. Stanley Shaldon. He often mentioned at that time that an efficient dialysis treatment was always associated with a shivering patient. Obviously, transport of endotoxins from the dialysis fluid across the membrane to the blood stream of the patient had caused febrile reactions. These observations were the basis of the “Interleukin hypothesis” [4, 5] and provided hints to the possible consequences of a bacterial contamination in any of the dialysis fluids.

Since then, the growing dialysis population and an increased patient survival have revealed many acute and chronic toxic consequences of exposure to inadequately prepared water and dialysis fluids. Furthermore, current dialysis practices, like the use of bicarbonate dialysis fluid, high-flux dialysis with highly permeable membranes as well as haemodiafiltration with large amounts of substitution fluids, require particularly “clean“ dialysis water.

Acute side effects, such as hypotension, muscular cramps, headaches and fever, have been attributed to the biological activity of small bacterial products, which may penetrate dialysis membranes. Interleukin-1 (IL-1), one of a number of cytokines, released from leukocytes upon stimulation by bacterial products, had already been established in 1984 as the general mediator for acute side-effects [6].

IL-1 has also been identified as a reason for chronic side-effects. Adverse clinical events, such as amyloidosis or chronic inflammation, as a consequence of a contaminated dialysis fluid in long-term haemodialysis patients, have been described in the literature [4, 7-11]. Dialysis water and fluid purity does not exclusively depend on microbial contamination, such as viable microorganisms. Bacterial derivatives from the outer bacterial cell membrane, like lipopolysaccharides or bacterial DNA, may also play an important role [11, 12]. The low molecular weight of endotoxin fragments or exotoxins allows their passage across the dialysis membrane from the dialysis fluid compartment to the blood stream.

The dialysis membrane is not a one-way-street

Mechanisms based on backfiltration or internal filtration, allow a reverse transfer of bacterial products particularly when highly permeable membranes are used. The development of membrane polymers that adsorb these molecules in the 1980s, such as polysulfone (PSu) or polyamide (PA) was one step further to a safe dialysis treatment.

Water quality is not exclusively limited to microbial contaminants. Other contaminants, such as colloids, heavy metals, organic and inorganic substances must also be restricted to a low threshold.

2. Haemodialysis water history - milestones


As an example, the development of encephalopathy and bone disease due to aluminium overload of the dialysis water is connected to some of the deleterious effects of chemical contamination of water for the haemodialysis patient.

Tap water from municipal water supplies is of insufficient quality for the direct use in haemodialysis. It must be processed with specifically designed water treatment devices.Since then, the water quality standards for haemodialysis have evolved and become more stringent, than those established for drinking water. In the early 1990s, analyses of water quality for dialysis in several countries [11, 13] have shown that, indeed, bacterial contaminants are present and the need for strict regulations was expressed.

Regulations and standards for drinking water are generally calculated on the premise of a water intake of 2 liters per day or 12 liters per week. Chronic haemodialysis patients however, under-going a 4-hour dialysis session thrice weekly, are exposed to more than 360 liters of dialysis fluid per week. Contaminants from drinking water can enter the blood stream only if they are resorbed in the gastrointestinal tract, whereas contaminants in dialysis fluid must only penetrate the non-selective semi-permeable dialyzer membrane to reach the blood stream.

Further, the use of contaminated water in reprocessing procedures for dialyzer reuse escalates the danger for haemodialysis patients, as the contaminants are directly brought onto the blood side of the dialysis membrane during the cleansing process of the reuse procedure.

Finally, the healthy subject is capable of excreting toxic substances by the kidney, but this is not so for the uremic patient in need of haemodialysis. Consequently, a dangerous accumulation of such toxins may result. Strict microbiological and chemical standards, specifically for dialysis water, are demanded today [13-15] and readily available.

2. Haemodialysis water history - milestones


2. Haemodialysis water history - milestonesReferences

References1. Graham T The Bakerian lecture: on osmotic forces.Phil Trans Royal Soc London, 144:177-228 (1854)2. Fick A Über DiffusionAnn Phys Chem, 94:59-86 (1855) 3. Robinson P, Rosen SPyrexial reactions during haemodialysisBr Med J, 6:528-539 (1971)4. Bingel M, Lonnemann G, Shaldon S, Koch KM, Dinarello CAHuman interleukin-1 production during haemodialysis.Nephron, 43:161-163(1986)5. Shaldon SThe interleukin-1 hypothesis: an update.Blood Purif, 6:162-163 (1988)6. Dinarello CInterleukin-1 and the pathogenesis of acute-phase response. N Engl J Med, 22:411-413 (1984)7. Knudsen P, Leon J, Ng A, Shaldon S, Floege J, Koch KHaemodialysis related induction of ß2-microglobulin and interleukin-1 synthesis and release by mononuclear phagocytes. Nephron, 53:188-193 (1989)8. Baz M, Durand C, Ragon A, Jaber K, Andrieu D, Merzouk T, Pur¬gus R, Olmer M, Reynier J, Berland YUsing ultrapure water in hemodialysis delays carpal tunnel syndrome. Artif Organs, 14:681-685 (1991)9. Quellhorst E, Schünemann B: Beta-2 amyloidosis and haemofiltration. In: Dialysis Amyloidosis. Eds: Gejyo F, Brancaccio D, Bardin T. Wichtig Editore, Milan, Italy; pp 123-129 (1989)10. Furuya R, Kumagai H, Takahashi M, Sano K, Hishida AUltrapure dialysate reduces plasma levels of ß2-microglobulin and pentosidine in hemodialysis patients. Blood Purif, 23:311-316 (2005)11. Arizono K, Nimura K, Motoyama T, Matsushita Y, Matsuoka K, Miyazu R, Takeshita H, Fukui HUse of ultrapure dialysate in reduction of chronic inflammation during hemodialysis.Blood Purif, 22 (Suppl. 2):26-29 (2004)12. Schindler R, Beck W, Deppisch R, Aussieker M, Wilde A, Göhl H, Frei UShort bacterial DNA fragments: detection in dialysate and induction of cytokines. J Am Soc Nephrol, 15:3207-3214 (2004)13. Bambauer R, Walther J, Meyer S, Ost S, Schauer M, Jung W, Göhl H, Vienken JBacteria and endotoxin-free dialysis fluid for use in chronic hemodialysis. Artif Organs, 18:188-192 (1994)14. Glorieux G, Neirynck N, Veys N, Vanholder RDialysis water and fluid purity: more than endotoxin. Nephrol Dial Transplant, 27:4010-4021 (2012)15. Smeets E, Kooman J, van der Sande F, Stobberingh E, Frederik P, Claessens P, Grave W, Schot A, Leunissen KPrevention of biofilm formation in dialysis water treatment systems. Kidney Int, 63:1574-1576 (2003)


3.1 Haemodialysis

The kidneys belong to the most important organs in our body. In addition to the control of homeostasis and electrolyte balance, detoxification and excretion of uremic retention solutes are their main functions. Given that the kidneys fail, renal replacement therapy is performed by dialysis. Blood purification and detoxification by haemodialysis or peritoneal dialysis allows today for even a long term survival of patients with end stage renal disease. In 2014, more than 2.6 million uremic patients received a renal replacement therapy worldwide, whereas conservative guesti-mates even indicate a number of nearly five million uremic patients that are in need of such a therapy [1]. Figure 3.1 represents the prevalence of dialysis patients in different countries of the world expressed in patient number per million population.

Figure 3.1: Figure 3.1: Patients receiving renal replacement therapy (RRT) in the world in 2010. The majority of kidney patients currently live in the USA, Europa and Japan. However, a gap between needed and delivered dialysis therapy can be observed, because analyses show that only a quarter to a half of those needing RRT worldwide in 2010, received it. Further, a rule of thumb shows that an average prevalence of 1000 patients per million population can be expected (adapted from [1]).

Haemodialysis is currently performed by guiding the patient´s blood outside the body through an extracorporeal blood circulation system, which consists of syringes, tubing, blood pumps and dialysers. Blood is taken from a shunt between the veins and arteries of the patient´s forearm. The blood then passes via blood tubes to the dialyzer, commonly called “artificial kidney”. Dialysis fluid is guided in a counter current flow pattern through the filter (see below), in order to remove

3Haemodialysis and its basic principles


Patients per million population <50-0 50.0-99.9 100.0-499.9 500.0-999.9 1000.0-1999.9 >2000.0 Values estimated by the model

-

water and dialysis fluids - dccdn.de€¦ · this book “water and dialysis fluids, ... the former...

Documents