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Patients with chronic kidney disease in the hemodialysis program are exposed to large amounts of water, as this constitutes about 96% of the dialysis fluid. It is known that the use of better quality water decreases the state of chronic inflammation in dialysis patients. Disinfection as part of water treatment plays an important role in meeting the established quality standards; currently, heat disinfection is highly recommended, however its dose is not clearly established in the literature. The objective of this review is to know what is available in the literature on the dose of heat disinfection that should be used in hemodialysis and to present our experience with this method at a set dose of 12.000 A 0 ., (Copyright © 2019 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.)

Objectives: In French health centers, the pharmacist is responsible for the quality of hemodialysis fluids. In an insular hospital, it is difficult to make bacteriological controls because of the lack of an environmental laboratory. Alternative choices of methods must be seek to facilitate water control and ensure the security of hemodialysis for patients. Controlling the microbiological risk is an essential condition for the good operation of a telemedicine partnership in dialysis., Methods: A review of the different methods that has been tried is presented. The hospital has experienced since 2014 a microorganism detection test by ATPmetry. An overview of the results is discussed., Results: The usability of this technique allows quarterly controls on the water treated by reverse osmosis and on fluids after one and two ultrafiltrations from every generator. Cases of non-compliance were due to false positives, which were squashed by verification control in 50% of the cases, and the other non-compliances were fixed by corrective actions., Conclusions: The ATPmetry technique permits the collection of rapid results and verification of the effectiveness of the corrective actions immediately after their implementation. This method has been undertaken in a routine use instead of the reference technique (bacteriological cultures). Assuming a constant vigilance in the quality of dialysis fluids that is a part of a quality approach, the pharmacist is at the heart of the telemedicine partnership developed in hemodialysis on the island., (Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

Background: With continuing economic development in the developing countries of Southeast Asia, the numbers of dialysis facilities and patients are increasing every year. However, dialysis-related devices tend to be provided with financial support from developed countries and/or donations from nonprofit organizations, and some donated devices are disposed of, without attempts at repair, when they break down. Device management and dialysate quality can also be problematic., Summary: To help address these issues, Japan started to provide technical guidance and support for dialysate purification in these countries. As a result, dialysate quality improved and local medical staff can now perform dialysis therapy using purified dialysate. At the same time, education was provided to staff, and their improved knowledge and skills have contributed to appropriate device maintenance, ensuring the dialysate used is of sufficient quality. Currently, approaches for human resource development are being actively provided in these countries through cooperation with local academic societies or other organizations in the field. Key Messages: A review of the current status of management of dialysis-related devices and dialysate quality in developing countries reveals that financial support and donations for medical devices alone are insufficient and the development of local human resources is crucial. Nurturing and training of clinical engineers, who directly operate today's advanced medical devices for patients, as well as device maintenance and management are urgent issues to address., (© 2017 S. Karger AG, Basel.)

Background: In 2008, the Japanese Society for Dialysis Therapy (JSDT) proposed a standard for the quality of fluids for hemodialysis. The standard was geared toward Japan, where the central dialysis fluid delivery system is routinely used. After establishment of the standard, dialysis fluid quality was markedly improved in facilities across the country. Moreover, the number of on-line hemodiafiltration patients dramatically increased., Summary: However, the 2008 standard specifies only microbiological qualities and does not cover toxic chemicals. The basis of toxic chemical management depends on the source water and water treatment equipment for hemodialysis, but no standard applies to water treatment equipment as a medical device. Specifications for the equipment were, for the most part, entrusted to individual manufacturers. Key Messages: The JSDT is investigating revision of its standard for dialysis fluid quality for hemodialysis to add control standards for toxic chemicals and water treatment equipment, with the aim of achieving quality of dialysis water superior to that of terminal dialysis fluid., (© 2017 S. Karger AG, Basel.)

Metabolic acidosis is a common complication of chronic kidney disease; it is typically caused by the accumulation of sulfate, phosphorus, and organic anions. Metabolic acidosis is correlated with several adverse outcomes, such as morbidity, hospitalization, and mortality. Thus, correction of metabolic acidosis is fundamental for the adequate management of many systemic complications of chronic kidney disease. In patients undergoing hemodialysis, acid-base homeostasis depends on many factors including the following: net acid production, amount of alkali given by the dialysate bath, duration of the interdialytic period, and residual diuresis, if any. Recent literature data suggest that the development of metabolic alkalosis after dialysis may contribute to adverse clinical outcomes. Our review is focused on the potential effects of different dialysate bicarbonate concentrations on hard outcomes such as mortality. Unfortunately, no randomized studies exist about this issue. Acid-base equilibrium is a complex and vital system whose regulation is impaired in chronic kidney disease. We await further studies to assess the extent to which acid-base status is a major determinant of overall survival in patients undergoing hemodialysis. For the present, the clinician should understand that target values for predialysis serum bicarbonate concentration have been established primarily based on observational studies and expert opinion. Based on this, we should keep the predialysis serum bicarbonate level at least at 22 mmol/l. Furthermore, a specific focus should be addressed by the attending nephrologist to the clinical and nutritional status of the major outliers on both the acid and alkaline sides of the curve., (Copyright © 2016 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.)

A Best Practice Guideline about Dialysis fluid purity was developed under the leadership of the Spanish Society of Nephrology in 2004. The second edition revised Guideline considered new evidences and International Standard. The Guideline has established recommendations for standards for preparing dialysate: water, concentrates and hemodialysis proportioning systems. This Guideline is based on the ISO13959, European Pharmacopoeia, the Real Farmacopea Española, the AAMI Standards and Recommended Practices, European Best Practice Guidelines for Haemodialysis, literature reviews, according to their level of evidence, and the opinion of the expert Spanish group. Two levels of quality of water were defined: purified water and high purified water (ultra pure) and for dialysate: ultra pure dialysate. Regular use of ultra pure dialysate is recommended for all type of hemodialysis to prevent and delay the occurrence of complications: inflammation, malnutrition, anaemia and amiloidosis. Water, concentrates and dialysate quality requirements are defined as maximum allowable contaminant levels: chemicals (4.1.2), conductivity, microbial and endotoxins (4.1.1): Monitoring frequency, maintenance and corrective actions were specified. Methods of sampling and analysis were described in appendix (anexos). For microbiological monitoring, R2A medium is recommended, incubated during 7-14 days at a temperature of 17-23°C. The dialysate quality assurance process involves all dialysis staff members and requires strict protocols. The physician in charge of hemodialysis has the ultimate responsibility for dialysate quality. All suggestions and questions about this Guideline are wellcome to www.senefro.org., (Copyright © 2016 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: The quality of dialysis fluid water might play an important role in hemodialysis patient outcomes. Although targeted endotoxin levels of dialysis fluid vary among countries, evidence of the contribution of these levels to mortality in hemodialysis patients is lacking., Study Design: Retrospective cohort study using data from the Japan Renal Data Registry, a nationwide annual survey., Setting & Participants: 130,781 patients receiving thrice-weekly in-center hemodialysis for more than 6 months were enrolled at 2,746 facilities in Japan at the end of 2006. None of the patients changed facility or treatment modality during 2007., Predictor: Highest endotoxin level in dialysis fluid reported by each facility during 2006. Patients were categorized by facility endotoxin level into the following groups: <0.001, 0.001 to <0.01, 0.01 to <0.05, 0.05 to <0.1, and ≥0.1EU/mL. Age, sex, dialysis vintage, diabetes mellitus as a primary cause of end-stage renal disease, Kt/V, normalized protein catabolic rate, dialysis session duration, serum albumin, and hemoglobin were measured as potential confounders., Outcome: All-cause mortality, censored by transplantation; withdrawal from dialysis treatment; or end of follow-up., Results: Of 130,781 hemodialysis patients, 91.2% had facility endotoxin levels below the limit set for dialysis fluid in Japan (<0.05EU/mL). During a 1-year follow-up, 8,978 (6.9%) patients died of all causes. The rate of all-cause mortality at 1 year was highest in the ≥0.1-EU/mL category (88.0 deaths/1,000 person-years). Patients in the ≥0.1-EU/mL group exhibited an increased risk of all-cause mortality of 28% (95% CI, 10%-48%) compared to the <0.001-EU/mL group., Limitations: Endotoxin level in dialysis fluid is reported as categorical data. No information about variation in endotoxin levels in dialysis fluid over time., Conclusions: Higher facility endotoxin levels in dialysis fluid may be related to increased risk for all-cause mortality among hemodialysis patients. Correcting this modifiable facility water management practice might improve the outcome of hemodialysis patients., (Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Introduction: The water used for dilution of hemodialysis concentrates has to meet official quality recommendations regarding microbiology and chemical parameters. To avoid chemical use and to simplify treatments, hot water has been used to control microbial contamination of water distribution systems. In this study we evaluated the efficacy of heat disinfection in maintaining the quality of dialysis water generated by reverse osmosis (RO)., Methods: During the first part of the study, we consecutively used (1) continuous water circulation, (2) daily heat disinfection and (3) a combination of daily heat disinfection and weekly chemical disinfection while checking bacterial count and endotoxin level every 4-5 weeks. During the second part of the study, we continued using daily heat disinfection while checking bacterial count and endotoxin level on weekly basis., Results: The endotoxin levels at all sampling points of the water treatment system were lower than 0.005/ ml throughout the study. The application of heat disinfection alone reduced bacterial levels but an escape phenomenon occurred. After an interval of 21 days, an exponential increase of bacterial count was noted and cultures from the RO unit revealed growth of Pseudomonas fluorescence. The addition of chemical disinfection was successful in eliminating micro-organisms. Throughout this study, micro-organisms and endotoxins were not detectable in dialysate fluid and substitution fluid in dialysis monitors., Conclusion: The isolation of a thermo-sensitive organism from the RO unit after a period of relying on thermal disinfection suggests the existence of dead space in the RO unit that is not adequately exposed to heat but is accessible to chemical disinfection. .

Background: Rapid intradialytic potassium shifts during haemodialysis have been associated with increased mortality and morbidity. Standardising dialysate potassium to 2 mmol/l may decrease the potassium shift., Objective: To examine the effect of standardising dialysate potassium to 2 mmol/l for all chronic dialysis treatments., Design: Pre- and post-intervention comparison of monthly serum potassium., Participants: Ninety-seven individuals, of whom 56 patients could be matched across both data collection periods., Methods: Serum potassium data were categorised based on a target range 3.5-6.0 mmol/l. Overall pre- and post-intervention mean scores were compared using a paired samples t-test. Data for patients routinely prescribed dialysate potassium 1 mmol/l pre-intervention (n = 6) underwent paired samples t-test to compare their mean serum potassium pre- and post-intervention., Results: There was no statistically significant change in serum potassium post-intervention. The majority of patients remained within the target range, including the subset of patients who had a history of high serum potassium during the pre-intervention period., Conclusions: A standard potassium dialysate of 2 mmol/l may reduce intradialytic serum potassium shifts and may assist in standardising safer work practices., (© 2013 European Dialysis and Transplant Nurses Association/European Renal Care Association.)

Over 383,900 individuals in the U.S. undergo maintenance hemodialysis that exposes them to water, primarily in the form of dialysate. The quality of water and associated dialysis solutions have been implicated in adverse patient outcomes and is therefore critical. The Association for the Advancement of Medical Instrumentation has published both standards and recommended practices that address both water and the dialyzing solutions. Some of these recommendations have been adopted into Federal Regulations by the Centers for Medicare and Medicaid Services as part of the Conditions for Coverage, which includes limits on specific contaminants within water used for dialysis, dialysate, and substitution fluids. Chemical, bacterial, and endotoxin contaminants are health threats to dialysis patients, as shown by the continued episodic nature of outbreaks since the 1960s causing at least 592 cases and 16 deaths in the U.S. The importance of the dialysis water distribution system, current standards and recommendations, acceptable monitoring methods, a review of chemical, bacterial, and endotoxin outbreaks, and infection control programs are discussed., (Published 2013. This article is a U.S. Government work and is in the public domain in the USA.)

Background: Patients treated with conventional hemodialysis (HD) develop disorders of mineral metabolism that are associated with increased morbidity and mortality. More frequent and longer HD has been associated with improvement in hyperphosphatemia that may improve outcomes., Study Design: Systematic review and meta-analysis to inform the clinical practice guideline on intensive dialysis for the Canadian Society of Nephrology., Setting & Population: Adult patients receiving outpatient long (≥5.5 hours/session; 3-4 times per week) or long-frequent (≥5.5 hours/session, ≥5 sessions per week) HD., Selection Criteria for Studies: We included clinical trials, cohort studies, case series, case reports, and systematic reviews., Interventions: Dialysate calcium concentration ≥1.5 mmol/L and/or phosphate additive., Outcomes: Fragility fracture, peripheral arterial and coronary artery disease, calcific uremic arteriolopathy, mortality, intradialytic hypotension, parathyroidectomy, extraosseous calcification, markers of mineral metabolism, diet liberalization, phosphate-binder use, and muscle mass., Results: 21 studies were identified: 2 randomized controlled trials, 2 reanalyses of data from the randomized controlled trials, and 17 observational studies. Dialysate calcium concentration ≥1.5 mmol/L for patients treated with long and long-frequent HD prevents an increase in parathyroid hormone levels and a decline in bone mineral density without causing harm. Both long and long-frequent HD were associated with a reduction in serum phosphate level of 0.42-0.45 mmol/L and a reduction in phosphate-binder use. There was no direct evidence to support the use of a dialysate phosphate additive., Limitations: Almost all the available information is related to changes in laboratory values and surrogate outcomes., Conclusions: Dialysate calcium concentration ≥1.5 mmol/L for most patients treated with long and long-frequent dialysis prevents an increase in parathyroid hormone levels and decline in bone mineral density without increased risk of calcification. It seems prudent to add phosphate to the dialysate for patients with a low predialysis phosphate level or very low postdialysis phosphate level until more evidence becomes available., (Copyright © 2013 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

The effects of high-flux dialysis and ultrapure dialysate on survival of hemodialysis patients are incompletely understood. We conducted a randomized controlled trial to investigate the effects of both membrane permeability and dialysate purity on cardiovascular outcomes. We randomly assigned 704 patients on three times per week hemodialysis to either high- or low-flux dialyzers and either ultrapure or standard dialysate using a two-by-two factorial design. The primary outcome was a composite of fatal and nonfatal cardiovascular events during a minimum 3 years follow-up. We did not detect statistically significant differences in the primary outcome between high- and low-flux (HR=0.73, 95% CI=0.49 to 1.08, P=0.12) and between ultrapure and standard dialysate (HR=0.90, 95% CI=0.61 to 1.32, P=0.60). Posthoc analyses suggested that cardiovascular event-free survival was significantly better in the high-flux group compared with the low-flux group for the subgroup with arteriovenous fistulas, which constituted 82% of the study population (adjusted HR=0.61, 95% CI=0.38 to 0.97, P=0.03). Furthermore, high-flux dialysis associated with a lower risk for cardiovascular events among diabetic subjects (adjusted HR=0.49, 95% CI=0.25 to 0.94, P=0.03), and ultrapure dialysate associated with a lower risk for cardiovascular events among subjects with more than 3 years of dialysis (adjusted HR=0.55, 95% CI=0.31 to 0.97, P=0.04). In conclusion, this trial did not detect a difference in cardiovascular event-free survival between flux and dialysate groups. Posthoc analyses suggest that high-flux hemodialysis may benefit patients with an arteriovenous fistula and patients with diabetes and that ultrapure dialysate may benefit patients with longer dialysis vintage.

Background/aims: Previous studies have suggested that online hemodiafiltration (OL-HDF) fluid can be used as dialysate for continuous renal replacement therapies, and thus HDF costs can be reduced. The aims of this study were to determine the purity of OL-HDF fluid and to verify the stability of the electrolyte composition and acid-base balance during its storage., Methods: OL-HDF fluid was collected in 70 individual bags and stored for up to 7 days. The following tests were performed daily in 10 bags: natural visible precipitation (macrocrystallization), sample collection for chemical analysis and fluid culture, limulus amebocyte lysate endotoxin test, standard culture of NALGENE® filters after passing of the fluid, and molecular analysis of bacterial DNA., Results: The values of pH and pCO(2) showed a significant change starting at 24 h (p < 0.001); after 72 h, their values were beyond the measurable range. Coefficient of variation for pCO(2) was as high as 25.7%. Electrolyte composition (Na(+), K(+), Cl(-), Ca(2+) and glucose) showed a statistically significant difference over time (p < 0.05); however, their coefficients of variation were low (1.7, 1.4, 0.6, 2.3 and 0.9%, respectively), which might not be considered clinically significant. Negative results were obtained at all points by fluid and filter cultures, endotoxin test and molecular analysis. No macrocrystallization was observed at any time point., Conclusions: We demonstrate the microbiological purity of OL-HDF fluid stored for up to 7 days. The electrolyte composition was stable, except for a relevant change in pCO(2) and consequently in pH (first noted at 24 h), emphasizing the need to reassess the acid-base balance in multilayer plastic bags in future studies., (Copyright © 2013 S. Karger AG, Basel.)

Hypo-responsiveness to erythropoiesis-stimulating agents (ESAs) has been associated with increased mortality. We examined the effect of water treatment component replacement on declining ESA responsiveness in the absence of chemical or microbiological standards failure. Pre-emptive renewal of the water treatment system supplying 802 standard-flux haemodialysis patients resulted in a significant rise in haemoglobin from (mean ± SD) 12.1 ± 1.2 to 12.3 ± 1.0 g/dl (p < 0.0001), accompanied by a significant decrease in prescribed dose of darbepoetin alfa from 47.9 ± 27.3 to 44.7 ± 27.6 μg/week (p < 0.0001). ESA responsiveness improved significantly from 0.060 ± 0.041 to 0.055 ± 0.040 μg/kg/g · dl(-1) (p < 0.0001) and the number of patients no longer requiring ESA therapy increased threefold. These benefits were derived in the absence of haemolysis or significant changes in water quality. Renewal of water system components should be conducted even in the absence of proven microbiological and chemical failure., (© 2013 S. Karger AG, Basel.)

Hemodialysis (HD) patients are exposed to large volumes of water, separated from patients' blood by semipermeable membrane of dialyzers. Chemical contaminants in poorly treated water impact negatively on quality of life of these patients. This survey was carried out to assess the HD water quality in Lagos, Nigeria. Ten milliliters of feed and treated water from all six HD centers in Lagos were tested for aluminum, copper, zinc, magnesium, calcium using atomic absorption spectrometry; sodium and potassium were tested using flame photometry, fluoride with molecular photoluminescence method; sulfate using turbidimetry, nitrates measured by cadmium column reduction method, chloramines and free chlorine were measured using N, N-diethyl-1-P-phenylenediamine colorimetric method. Information on sources of feed water, frequency of testing of HD water, methods of water treatment, type of water purification system and maintenance was also obtained. All centers used borehole as main source of water supply. None of the centers met Association for the Advancement of Medical Instrumentation (AAMI) guidelines for most chemical contaminants. Only chlorine (0.48 ± 0.07 mg/L) and potassium (3.9 ± 0.95 mg/L) levels met AAMI standards after treatment. Mean levels of chemical contaminants in treated water were as follows: aluminum 0.04 ± 0.01 mg/L, zinc 0.27 ± 0.08 mg/L, chloramines 0.16 ± 0.03 mg/L, fluoride 1.83 ± 0.40 mg/L, sulfate 117 ± 86.1 mg/L which were mildly elevated; calcium 126.00 ± 22.7 mg/L, sodium 179 ± 25.6 mg/L, and nitrate 70.5 ± 50.8 mg/L, which were markedly elevated; and magnesium 8.3 ± 3.38 mg/L, which was moderately elevated above AAMI recommended levels. HD water quality is poor in our environment. Concerted efforts are required to ensure good quality water for HD., (© 2012 The Authors. Hemodialysis International © 2012 International Society for Hemodialysis.)

Dialysis water optimization is not only a medical but also a moral and legal obligation, especially with the now widespread use of online systems requiring ultrapure, close to sterile water as well as strict staff adherence to protocol. Public health should allow expenditure for the most modern and secure equipment to ensure maximum safety to our hemodialysis patients and less morbidity, mortality and hospitalization. Doctors, nurses and technicians alike must acquire the necessary knowledge and procedures to consider and treat dialysis water on a par with a drug to be administered.

Aim: This report attempts to illustrate the positive impact on the quality of dialysis water produced over a 16-year period through the progressive optimization of technological procedures., Methods: Fundamental steps included the following: elimination of polyvinyl chloride (PVC), periodical controls, introduction of stainless steel and/or polyethylene polymer and substitution of single-pass reverse osmosis (SRO) with double-pass reverse osmosis (DRO). Daily overnight automatic thermal disinfection of distribution piping rings represented the final step., Results: A dramatic improvement was observed in 645 water samples obtained from distribution piping. The measures applied resulted in a significant improvement of water quality, featuring levels of colony-forming units per milliliter ranging from 247.4 ± 393.7 in the presence of PVC and SRO to 14.1 ± 28.0 with stainless steel and DRO and 2.8 ± 3.2 with cross-linked polyethylene thermoplastic polymer and DRO (p < 0.01)., Conclusions: Dialysis water should be viewed by nephrologists as a medicinal product, and every effort should be made to ensure a high-quality liquid., (Copyright © 2012 S. Karger AG, Basel.)

Acute kidney injury affects about 35% of intensive care unit patients. Renal replacement therapy is required in about 5% of such patients and is associated with a mortality rate as high as 50% to 80%. The latter is likely more related to the failure of extrarenal organs than to an insufficient dialysis dose. This could explain, at least in part, the findings of 2 recent trials (VA/ NIH and RENAL) where the expected dose-outcome relationship was not confirmed. These results cannot be taken to infer that assessing the dialysis dose is no longer required. The contrary is true, in that the common finding of large differences between prescribed and delivered doses calls for accurate dose assessment, at least to avoid underdialysis. The minimum adequate levels are now a Kt/V urea of 1.2 to 1.4 three times a week (3x/wk) on intermittent hemodialysis (IHD), and an effluent of 20 mL/kg/h for 85% of the time on continuous renal replacement therapy (CRTT). Both these parameters can be easily measured but are far from ideal indices because they account neither for residual renal function nor for irregular dose delivery. The equivalent renal urea clearance (EKRjc), by expressing the averaged renal+dialytic urea clearance over the whole treatment period, is able to account for the above factors. Although assessing EKRjc is quite complex, for regular 3x/wk IHD one could use the formula EKRjc=10 Kt/V+1 to compute that a Kt/V of 1.2 and 1.4 corresponds to an EKRjc of 13 and 15 mL/min, respectively. On the other hand, the hourly effluent per kg is numerically similar to EKRjc. On this basis it can be calculated that in non-prediluted really continuous treatment, the recommended CRRT dose (EKRjc=20 mL/min) is 33% higher than the EKRjc of 15 mL/min, corresponding to the recommended Kt/V of 1.4 on 3x/wk IHD.

Dialysis is a well-established and widely used procedure. For a number of years, the focus has been on ensuring that water used in the preparation of dialysis fluid meets the required chemical and microbiological quality and complies with national or international standards which have recently been updated. Continued vigilance is required, in particular when new chemicals such as silver-stabilized hydrogen peroxide and chlorine dioxide are used to prevent growth of Legionella bacteria in hospital water systems, since residues are harmful to patients receiving dialysis. To achieve the required quality, large volumes of water are processed, and a substantial portion is sent to waste via the municipal sewer systems with little attempt to reuse such water on site. In view of concern about global warming and climate change, there is a need to adopt a more environmentally conscious attitude requiring dialysis providers to focus on this aspect of water usage., (Copyright (c) 2010 S. Karger AG, Basel.)

The composition and quality of the dialysis fluid play an important role in the modulation of dialysis-related complications. During hemodialysis, patient's blood has a contact with dialysate through a semipermeable membrane. Bacterial endotoxins can pass through the membrane pores into the patient's blood and cause a silent chronic microinflammation. The aim of this study was to determine the level of endotoxins in hemodialysis water and dialysate in Lithuanian hemodialysis centers. Dialysis water (n=50) and dialysate (n=50) were collected from 91% (n=50) of all hemodialysis centers. The presence of bacterial endotoxins was evaluated using a sensitive Limulus amebocyte lysate test, which detects intact lipopolysaccharides. The level of endotoxins was lower than 0.25 EU/mL in 43 (86%) dialysis water samples and in 46 (92%) dialysate samples, and complied with the recommendations of the European Pharmacopoeia and the European Best Practice Guidelines for pure dialysis fluid. The dialysate of 39 (78%) Lithuanian hemodialysis centers complied with the definition of an ultrapure dialysis fluid. The water and dialysate were of insufficient quality in 14% and in 8% of Lithuanian hemodialysis centers, respectively, and this could be improved by the establishment of routine investigation of endotoxins.

Recommendations/guidelines regarding the microbiological and chemical quality of fluids in dialysis are increasing in numbers, both nationally and internationally. As dialysis is a worldwide issue, with many elements being similar regardless of geographical area, it is logical to have the same quality requirements on fluids used in dialysis. At present, there are large differences between the different documents. This situation makes studies where several nations participate more difficult to interpret as the fluids used in dialysis are crucial for the dialysis session. A special situation applies for substitution fluid produced 'On-Line' for haemodiafiltration (HDF) and haemofiltration (HF), where some recommendations are questionable from a scientific standpoint. The International Organisation for Standardisation (ISO) is in the process of finishing a collection of standards including guideline for fluids in dialysis (water, concentrates, dialysis fluid, substitution fluid) and equipment used for water preparation. To have the same quality for reference worldwide will facilitate the interpretation of international studies as well as give dialysis patients treatments based on the same quality baseline.

The Committee of Scientific Academy of the Japanese Society for Dialysis Therapy (JSDT) proposes a new standard on microbiological management of fluids for hemodialysis and related therapies. This standard is within the scope of the International Organization for Standardization (ISO), which is currently under revision. This standard is to be applied to the central dialysis fluid delivery systems (CDDS), which are widely used in Japan. In this standard, microbiological qualities for dialysis water and dialysis fluids are clearly defined by endotoxin level and bacterial count. The qualities of dialysis fluids were classified into three levels: standard, ultrapure, and online prepared substitution fluid. In addition, the therapeutic application of each dialysis fluid is clarified. Since high-performance dialyzers are frequently used in Japan, the standard recommends that ultrapure dialysis fluid be used for all dialysis modalities at all dialysis facilities. It also recommends that the dialysis equipment safety management committee at each facility should validate the microbiological qualities of online prepared substitution fluid.

The Japanese Society for Dialysis Therapy (JSDT) surveyed all dialysis facilities for bacteriological quality of dialysis fluid and quality controls for dialysis fluid in 2006 and 2007. The JSDT collected the data for endotoxin (ET) levels, bacterial count and usage of ET retentive filters (ETRF). The JSDT standard for ET level in dialysis fluid (<0.050 EU/ml) was achieved in 89.0% in 2006 and in 93.6% in 2007. The JSDT standard for bacterial cell counts in dialysis fluid (<100 cfu/ml) was achieved in 96.9% in 2006 and in 97.4% in 2007. The central dialysis fluid delivery system (CDDS) is a unique system developed in Japan which has easy handling for daily maintenance of delivery systems, but it has been pointed out that CDDS has a weak point for the protection of biofilms. However, the bacteriological water qualities of dialysis fluid in CDDS were proven to be extremely high in most Japanese dialysis facilities by JSDT surveys. Bacteriological water quality has a strong impact on the patient outcome. The acceptable level of ET of dialysis fluid should be <0.1 EU/ml based on the results of JSDT survey. The excellent water quality in CDDS might be one of the important factors which help good patient survival in chronic dialysis in Japan., ((c) 2009 S. Karger AG, Basel.)

Quality standards for dialysis water have existed for more than 25 years. Current standards generally agree concerning the maximum allowable levels of chemical contaminants; however, significant differences exist concerning the maximum allowable levels of microbiological contaminants and the methods used to measure them. While quality standards for dialysis water are common, there are relatively few standards or recommendations for dialysis fluid quality and these also differ markedly in the maximum allowable level for microbiological contaminants. Compliance with quality standards for dialysis water and dialysis fluid appears to have improved over the past 20 years, although the actual extent of compliance is difficult to assess. A universal standard for fluid quality might be of benefit to the wider dialysis community; however, progress towards that goal will depend on resolution of important issues, including how the standard is to be applied, if it should be limited to substances with documented toxicity for hemodialysis patients, and how to address microbiological contaminants., ((c) 2009 S. Karger AG, Basel.)

There has been remarkable medical and technological progress in Japanese dialysis therapy where more than 270 thousand patients had been treated with dialysis by the end of 2007. Clinical engineering technologists have played an important role not only in the safety treatment but also in the technological development of dialysis therapy. It is very important to supply pure dialysis fluid for both the efficacy and the safety of hemodialysis in which high permeable dialysis membranes are used. The Japanese Society for Dialysis Therapy recently issued the standard for bacterial management of fluids for hemodialysis and related therapies according to the International Organization for Standardization (ISO)/DIS 23500. In order to achieve the standard, the management of dialysis water treatment is important as well as the role of clinical engineering technologists in daily dialysis practice. Purification is defined as no contamination by chemical substances and/or microorganisms and its components. The purification consists of the design and the system structure of the water treatment equipment and dialysis fluid-supplying equipment, and the operation and management of the equipment. The guideline aims to show the minimum standard and the management method of the water treatment system and dialysis fluid-supplying equipment in order to perform hemodialysis safely. They should outline safer dialysis by the management of purification of dialysis fluid., ((c) 2009 S. Karger AG, Basel.)

When dialysis became a chronic therapy, certain clinical symptoms could be connected to the fluid quality and some form of water treatment had to be introduced. The required equipment was empirically developed and consisted of sedimentation filters, carbon filters and softeners. In the mid-1970s the toxic effect of aluminum accumulation was discovered and led to the introduction of reverse osmosis modules. When these components - prefilters, softeners and RO modules - are properly maintained, they produce water of a quality that should meet modern standards. However, the water quality could be ruined by bacterial contamination from the distribution pipes, unless the entire flow path is hygienically designed and frequently disinfected. The quality of the concentrate is also important, especially the bicarbonate component which is prone to bacterial growth. The extent of the microbiological burden in water and dialysis fluid has been brought to the attention of the dialysis community through new and sensitive detection and quantification methods for bacteria and endotoxin., ((c) 2009 S. Karger AG, Basel.)

The standard of fluids for hemodialysis is being evaluated by the International Organization for Standardization (ISO), and will be decided within a few years. In 2008, the Japanese Society for Dialysis Therapy (JSDT) proposed the standard of fluids for hemodialysis by taking the draft ISO standard into consideration and the circumstances in Japan. It was characteristically a standard for Japan, where the central dialysis fluid delivery system (CDDS) is routinely used. In addition, the therapeutic application of each dialysis fluid is clarified. Since high-performance dialyzers are frequently employed in Japan, the standard recommends that ultrapure dialysis fluid be used for all dialysis modalities at all dialysis facilities. It also recommends that the dialysis equipment safety management committee at each facility validate the microbiological qualities of online-prepared substitution fluid, making the responsibility of the dialysis facility clear. This standard is more rigid than those of other countries, and is expected to contribute to improvements in the survival outcome of dialysis patients., ((c) 2009 S. Karger AG, Basel.)

Microinflammation in renal failure has been the subject of numerous contributions to the literature. The bacterial contamination of dialysate and subsequent transfer of bacterial products onto the blood side is an important cause for microinflammation in hemodialysis patients. It has been suggested that the inflammatory process may not merely be an epiphenomenon but rather a pathogenetic factor in the genesis of atherosclerosis [1,2,3]. Thus, by promoting microinflammation, dialysate contamination may contribute directly to cardiovascular morbidity and mortality., ((c) 2009 S. Karger AG, Basel.)

The central dialysis fluid delivery system (CDDS) has been mainly used for hemodialysis therapy in Japan. Validation and a parametric method are necessary for the quality control of dialysis fluid in CDDS. Validation is a concept for the assurance of system compatibility and product quality, and is defined as follows: the manufacturing and quality control methods including the system design and equipment of the manufacturing facility, manufacturing procedure and processes. Confirmed results must be kept within acceptable limits and they must be documented in a record. Important parameters for validating CDDS include: (1) setting the sterilized area; (2) decision of sterilization level; (3) confirmation of the maximum bio-burden; (4) performance of endotoxin retentive filter and reverse osmosis (RO) module, and (5) checkpoints of purity of dialysis water in the system. Taking the concept of validation and a parametric method in the management of CDDS into consideration enables the supply the purified dialysis fluid or the online prepared substitution fluid that meet the 2008 standards of the Japanese Society for Dialysis Therapy., ((c) 2009 S. Karger AG, Basel.)

Renal-replacement therapies are among the most invasive techniques used in the intensive-care units. An increased security of these methods can be expected from interventions on several areas. Teaching and training are probably the more important due to the complexity of both techniques and devices. The interest and the limits of the monitoring techniques need to be known as well as the guidelines for an optimal ordering. As often, a set of written procedures must ideally be constructed by the ICU team then learned and periodically revised.

The dialytic process utilizes high volumes of water in the preparation of the dialysis fluid. Improvements in water treatment equipment have resulted in improvements in chemical quality. Awareness that endotoxin and bacterial fragments present in the water distribution loop within the dialysis, are able to cross the dialyser membrane, has resulted in an increased focus on this aspect of water quality. Practically, the age of many water treatment plants, extensions of distribution systems and suboptimal cleaning procedures have prevented the achievement of optimal microbiological quality on a routine basis. When achieved and maintained, clear benefits to the patient have been demonstrated. Hemodialysis patients are also subject to increased oxidative stress which may also contribute to their morbidity and mortality. Recent clinical studies using dialysis fluid made with electrolytereduced water have demonstrated benefits to antioxidant status of dialysis patients, offering a further technological solution to the problem of increased cardiovascular disease in dialysis patients.

Online production of substitution fluid by 'cold sterilization' (ultrafiltration) of dialysis fluid gives access to virtually unlimited amounts of sterile and nonpyrogenic solution. The incorporation of the online hemodiafiltration (ol-HDF) module into the dialysis proportioning machine hardware simplifies the handling procedure, secures the process by keeping the safety regulation of the monitor and offers virtually unlimited amounts of sterile and nonpyrogenic substitutive solution. The safety of the ol-HDF relies upon use of ultrapure water and strict and permanent highly hygienic rules of use. The use of a specifically designed certified HDF machine is also mandatory. Several forms of ol-HDF have been developed and used to cover specific clinical needs of chronic kidney disease patients. Conventional ol-HDF are classified according to the mode of substitution as post-, pre- and mixed dilution. Alternative-based ol-HDF incorporate push/pull HDF, double high-flux HDF, paired HDF and middilution HDF. A very simple description of these methods is provided in this section. Best clinical practices are summarized in this section to optimize performances of ol-HDF and maximize the safety of the method. It is noteworthy to stress the important role of blood flow, fluid volume exchange, hemodiafilter performances and duration of sessions in the overall treatment efficacy. It is also crucial to insist on the importance of strict hygienic handling, microbiology monitoring and the quality assurance process to ensure the safety of the method. In addition, ol-HDF offers the best technical platform to develop new therapeutic strategies such as daily treatment, total automation of priming and cleansing procedures and biofeedback volume control.

Unlabelled: Hemodialysis is a process when the blood of patients contacts with dialysate through a semipermeable membrane. Water used for dialysis is not sterile. Microorganisms cannot pass through the membrane pores, but bacterial endotoxins can diffuse to the blood of patients. Several acute and long-term complications (pyrogenic reactions, silent chronic inflammation, malnutrition) in dialysis patients might be associated with dialysate contamination. The aim of this study was to determine the level of endotoxins in hemodialysis water and dialysate in several hemodialysis centers of different Lithuanian cities., Material and Methods: Material was dialysis water (n=6) and dialysate (n=14) from six hemodialysis centers in three different cities of Lithuania. Bacterial endotoxin levels were measured using a sensitive Limulus Amebocyte Lysate (LAL) assay., Results and Conclusions: The level of endotoxins was less than 0.25 endotoxin unit (EU)/mL in all hemodialysis water (n=6) and dialysate (n=14) samples. One sample of water (16.7%) and two of dialysate (14.3%) had the level of endotoxins above 0.03 EU/mL. Therefore, the level of endotoxins in hemodialysis water and dialysate in studied Lithuanian hemodialysis centers (n=6) complied with the recommendations of the European Pharmacopoeia and the ERA-EDTA best practice guidelines for conventional dialysis modalities. The level of endotoxins in dialysate of five Lithuanian hemodialysis centers complied with the recommendations of the ERA-EDTA best practice guidelines for ultrapure dialysate.

The biologic response to uremia and to the associated chronic inflammation is an active area of research. Among the different modalities developed in the technology field of chronic renal replacement, hemodialfiltration has evolved consistently. On-line production of substitution fluid by 'cold sterilization' of dialysis fluid by ultrafiltration gives access to virtually an unlimited amount of sterile and non-pyrogenic intravenous grade solution. Today, on line HDF is already a widespread, accepted treatment. Here, we will review the main mechanisms through which on line hemodialfiltration acts and the biological response observed in relation to the immune system dysfunction and the anemia associated to chronic kidney disease.

Great improvements in water treatment technology and the spread of ultrafiltration for cold sterilization have been the basic support for the development and diffusion of on-line dialysis treatments. Some 20 years ago, nephrologists recognized that the official standards for dialysis fluids were insufficient with respect to these new treatment modalities, and ultrapure water (bacteria <0.1 CFU/ml; endotoxin <0.03 EU/ml) was proposed as a reference. Today, ultrapure water is included in most guidelines and recommended standards, but there remains a need for harmonization between standards. To achieve and ensure these levels of purity, technology must be supported by commitment of resources to an active quality assurance programme with adequate maintenance, monitoring, cleaning, sanitizing and problem analysis procedures.

Mid-dilution (MidD) is a new concept allowing post- and predilution in the same dialyser (Olpur MD 190). The aim of the study was to compare, in 6 patients, MidD with post and predilution wird regard to purification tests, such as reduction ratios and instantaneous whole-blood clearances, of urea, creatinine and phosphorus as examples of low-weight molecules and of Beta2-microglobulin as an example of a middle molecule (MM). The aim was also to indicate directions for the use of this new dialyser, taking into account our own experience and the few observations already published. It was concluded that MidD, under excellent safety conditions, in spite of increased intradialyser pressures, offers a very high purification performance, particularly for MM, because of high convective volumes exceeding the recommended objectives for a better survival in dialysis.

It has generally been accepted that biological contamination of dialysate deteriorates the biocompatibility of dialysis therapy and accelerates dialysis-related complications such as dialysis-related amyloidosis (DRA) and malnutrition-inflammation-atherosclerosis (MIA) syndrome. During the past decade several studies have clarified that very slight amounts of contamination can lead to inflammatory response, and we could not confirm biological dialysate quality only by measuring endotoxin levels despite of measuring viable cell counts or biofilms. To achieve this, the European Renal Association/European Dialysis Transplantation Association and the American National Standardization Institute/Association for the Advancement of Medical Instrumentation published new standards for dialysate, in which very strict control levels were recommended with regard to viable bacterial cell counts. In 2004 JSDT raised the required standard of the levels of endotoxin, and began to develop a standard for bacterial cell counts. In Japan, many chronic kidney disease patients are treated with centralized dialysate supply systems which have weak spots in disinfecting the system. This causes some difficulties in making a standard for viable bacterial cell counts. In the present paper, we summarize evidences of clinical usefulness of ultrapure dialysate and perspectives of the standard for dialysate in Japan.

Background: Routine water monitoring in a haemodialysis centre revealed high trichloroethylene (TCE) concentrations. The aim of this study is to describe the measures adopted after organic contamination of dialysis water in order to avoid the possibility of patient exposure. We also carried out in vitro experiments to evaluate the accumulation of TCE in various devices normally used in a dialysis water treatment system (DWTS)., Methods: In vivo and in vitro blood and water TCE levels were determined by means of solid phase microextraction-gas chromatography/mass spectrometer., Results: High TCE concentrations were found throughout the DWTS; acceptably low levels were obtained only by replacing the activated charcoal, ionic-exchange resins, microfilters and PVC pipes. The adsorption and realising capacities of these devices were tested in vitro, and the elimination curves made it possible to calculate the total percentage of the previously absorbed TCE mass released into the water. Evidence of exposure was confirmed by the relatively high TCE levels in the patient blood samples taken 30 days after the last exposure even if the subjects were asymptomatic. In vivo experiments showed that the blood gain of TCE through the low flux membrane during the course of dialysis was about 77+/-10.4% of the amount carried by dialysis fluid as calculated on the basis of its partition coefficient value (K(b/w) 3.75)., Conclusions: This study shows that, when present in dialysis water, the lipophilic TCE contaminant can accumulate in various devices, thus transforming them into possible sources of exposure. This highlights the importance of periodically monitoring dialysis water for organic substances that have a great affinity to the blood compartment, in order to prevent occasional or chronic patient exposure.

We describe a simple, rapid, and sensitive fluorescence method for measurement of aluminum (Al) in human biological fluids, in dialysis solutions, and in tap water, which uses 8-hydroxyquinoline for ion chelation. The fluorescence intensity of the toluene-extracted metal chelate (excitation wavelength, 380 nm; emission wavelength, 504 nm) remains unchanged for over 48 h at room temperature. Fluorescence intensity is a linear function of the concentration of Al in the 2-1000 microg/L range with detection limits of 0.7-2 microg/L. A large excess of other ions normally found in biological fluids does not interfere in Al determination. The method developed was successfully used in assaying Al in serum and urine of reference subjects, in serum samples from patients undergoing long-term dialysis, and in dialysis solutions. Al concentrations, measured by this fluorimetric procedure, were compared with those obtained by Zeeman graphite-furnace atomic absorption spectrometry. A correlation coefficient of 0.98 was obtained. The proposed method could be used for routine analysis in clinical laboratories for accurate determination of aluminum in aqueous or biological fluids.

Background: The K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease was published in October 2003. The objective of this study was to analyse the effect of the application of those guidelines on clinical practices and on the achievement of bone disease targets and quality standards., Methods: We included in the study 342 patients dialysed in our three HD units during 2003 and 2004. Starting October 2003, the K-DOQI recommendations were introduced into practice. Parathyroid hormone (PTH) was measured every 3 months and the serum Ca and P levels, monthly. In patients whose medications were modified, PTH was measured monthly and Ca and P levels, weekly or biweekly., Results: The following are the main findings for 2004 (post-K/DOQI): an increased use of dialysates with a Ca concentration of 2.5 mEq/l (27.2-50.9%, P<0.001) and a reduced use of a dialysate calcium of 3.0 mEq/l (44.6-39.6%, P: NS) and 3.5 mEq/l (28-9.4%, P<0.001); a reduced use of calcium-based phosphate binders (891.9-565.5 mg Ca/day, P<0.001) and increased use of sevelamer hydrochloride (800 mg) (from 4.86 to 7.51 mg, tablets/day, P<0.001) lower serum Ca levels (9.7-9.4 mg/dl, P<0.01), and higher intact PTH levels (201.4-311.8 pg/ml, P<0.001), without changes in serum P levels; an increased proportion of patients with serum Ca levels within the K/DOQI target range (38.7-46.6%, P<0.01), resulting mainly from the reduced percentage of patients with hypercalcaemia (55-44.4%, P<0.01); a decreased proportion of patients with PTH<150 pg/ml (53.8-31.4%, P<0.001) but an increased proportion of patients with PTH>300 pg/ml, with no change in the proportion of patients with PTHs within the K/DOQI target range. Phosphorus levels and targets did not show significant differences between 2003 and 2004 (56.9-56.2%, P: NS)., Conclusions: The only way to ensure that K/DOQI guidelines actually improve medical outcomes is to emphasize implementation strategies and also the scientific evaluation of their effectiveness in clinical settings. In spite of the application of the K-DOQI recommendations, a large proportion of our patients stayed outside the proposed targets, which points to the need for more effective therapeutic options.

Water treatment system and dialysis monitors are susceptible to microbial contaminations and periodical disinfection procedures are mandatory to obtain results requested from international standards and guidelines. Several chemical germicides or some physical treatments are on the market validated by device manufacturer according to medical device directives. With time, interfering substances from dialysis device or water are able to modify disinfection efficiency. Simulating-use testing is not a common procedure to validate disinfectants and recent data document as biofilm represents the most important cause of disinfection inefficacy. Some international standards include tests in the presence of various interfering substances but their use is not widespread. When using a disinfectant, residue toxicity, material compatibility and potential risks for the staff also have to be considered. A quality assurance program has to be implemented to obtain adequate performances and to improve results on patients.

Treatment of renal failure by haemodialysis uses dialysis fluid to facilitate the normalization of electrolyte and acid base abnormalities and the removal of low molecular weight uraemic compounds present in the plasma such as urea. The dialysis fluid is a continuously produced blend of treated tap water and a concentrated solution containing electrolytes, buffer, and glucose. The water used originates as drinking water but undergoes additional treatment. Recent surveys have indicated that the chemical and microbiological content of such water frequently fails to meet the requirements of established standards, and its bacterial content arising from the presence of a biofilm in the water distribution network or the hydraulic circuit of the dialysis machine is a contributory factor to the chronic inflammatory state in patients undergoing regular dialysis. The composition of the dialysis fluid plays an important role in the modulation of complications associated with end-stage renal disease, as well as those associated with the treatment itself. The avoidance of complications arising from water contaminants requires a constant and vigorous attention to water quality, whilst with the composition of electrolytes and buffer there is a trend towards greater individualization to provide a high degree of treatment tolerance., (Copyright 2006 S. Karger AG, Basel.)