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We accept that there is no firm evidence that replacement, as suggested above, is the most cost-effective strategy. Guideline 3. Individualisation of dialysate potassium may be required in patients with hypokalaemia and adjustment of dialysate sodium concentrations during HD (sodium profiling) may be beneficial in some patients with haemodynamic instability. Effectiveness and safety of different hemodialysis modalities: a review. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. Termorshuizen F, Dekker FW, van Manen JG et al. Regional variation in the level of provision of HD within the UK continues and this needs to be addressed to permit equity of access to HD throughout the country (5). The more stringent limits may only be met using a double pass reverse osmosis water treatment system which is not universally used and, in view of this, the less stringent recommendation has been adopted for nitrate. Randomised trial of high-flux versus low-flux haemodialysis: effects on homocysteine and lipids. Haemodiafiltration, haemofiltration and haemodialysis for end-stage kidney disease. For these reasons a reduction in the dialysate glucose concentration may be useful. The aim of implementing a disinfection programme is to prevent formation rather than elimination of biofilm and a routine testing procedure for microbiological contaminants in dialysate, dialysis water and feed water should form part of the renal unit policy. However, when the number of prevalent years on HD was analysed as a continuous variable, the interaction of flux and years of dialysis on patient survival was not significant. Jackson MA, Holland MR, Nicholas J et al. (1B) Rationale Knowledge of the potentially harmful effects of trace elements and chemicals continues to expand and techniques of water treatment are continuously being modified. 1 - HD: Biocompatible haemodialysis We suggest that haemodialysers with synthetic and modified cellulose membranes should be used instead of unmodified cellulose membranes. Haemodialysis (HD) (Guidelines 4. Dialyser membrane characteristics and outcome of patients with type 2 diabetes on maintenance haemodialysis. Effect of dialysis dose and flux on mortality and morbidity in maintenance hemodialysis patients: Primary results of the HEMO study. The required capacity for HD will be greater in areas with a high ethnic or elderly population due to their higher prevalence of established renal failure and these areas will need proportionately greater HD capacity than the national average. If HDF is shown to provide better patient outcomes than high flux HD, HDF will become the default therapy for all patients with established renal failure. 9% to 3. low-flux polysulphone). Some patients may be only willing to travel for HD twice weekly for reasons of geography but they should receive a higher sessional dose of dialysis. Serum albumin was slightly higher at certain time points in some studies when synthetic membranes of both high and low flux were used and this may be an important finding given the adverse prognostic impact of hypoalbuminaemia in dialysis patients (4,5). (1C) Rationale The manufacturer of the water treatment plant and distribution system should demonstrate that the requirements for microbial contamination are met throughout the complete system at the time of installation (1). (2C) Rationale Additional capacity is needed to allow for patient choice of HD schedule, more frequent HD schedules, holiday HD and anticipated expansion in patient numbers. Cellulose, modified cellulose and synthetic membranes in the haemodialysis of patients with end-stage renal disease. Effect of increased convective clearance by on-line hemodiafiltration on all cause mortality in chronic hemodialysis patients - the Dutch CONvective TRAnsport STudy (CONTRAST): rationale and design of a randomised controlled trial. Haemodialysis (HD) (Guidelines 5. (1C) Guideline 7. Statutory Instrument No. Association of morbidity with markers of nutrition and inflammation in chronic hemodialysis patients: A prospective study. While the use of high flux membranes can increase this, a more effective way of promoting MM clearance is to superimpose convection upon standard diffusive blood purification technique using haemodiafiltration (HDF). Detection, Monitoring and Care of Patients with CKD. There was no survival advantage associated with the use of high flux membranes in the total MPO study population (6) and no survival advantage with the use of high flux membranes was observed in hypoalbunaemic patients in the HEMO study (9). 1 - 4. For these reasons the calculated number of dialysis stations that are required in each geographical area should be based on using each machine only for two patients per day three days per week. Permeability of dialyzer membranes to TNF alpha-inducing substances derived from water bacteria. 9 - HD: Residual renal function We suggest that the management of haemodialysis patients should include dialysis strategies that attempt to preserve their residual renal function. Testing is only required if there is evidence of high levels in the local water supply (zinc, for example, can be introduced in the pipework). 2 - HD: High flux HD membranes We suggest that high flux dialysers should be used instead of low flux dialysers to provide haemodialysis. Most of these confounding factors have been addressed in the Membrane Permeability Outcome (MPO) study which is a prospective, randomized, multicentre European study comparing the use of high flux and low flux membranes in 738 incident HD patients who have few exclusion criteria and do not reuse dialysers (6). Hypoalbuminemia, cardiac morbidity, and mortality in end-stage renal disease. The hemodialysis (HEMO) study: rationale for selection of interventions. If the patient is in a steady state nutritionally, this gives information on current protein intake, and may be a useful adjunct to other methods of assessment of nutritional status. Canaud B, Bragg-Gresham JL, Marshall MR et al. The authors have acknowledged that there was a small arithmetic error in this systematic review although this did not alter its main conclusion (3). Patients who are receiving twice weekly HD without an increase in treatment time should be informed explicitly that this is a compromise between the practicalities of dialysis delivery and their long-term health. The Water Supply (Water Quality) (England and Wales) Regulations 2000. Despite the relatively large number of randomised controlled trials undertaken in this area, none of the studies that were included in the review reported any measures of quality of life. Effect of membrane flux and dialyser biocompatibility on survival in end-stage diabetic nephropathy. Read All the Guidelines Download this and previous pdfs Authors of this guideline were: Dr Robert Mactier. A comparison of the costs, quality of dialysis, quality of life and frequency of adverse events of HD in satellite and main renal units in England and Wales showed no major differences except the adequacy of HD, as assessed by measurement of the urea reduction ratio, was better in the patients treated in satellite units (5,6). The tests used for monitoring microbial contamination of water for dialysis should be appropriate to the type of organisms found in water. For practical reasons HD adequacy thus far has been measured using small, easily measured solutes such as urea (1-3) Three methods of assessing urea removal are in current use (1,2): a) The URR (4) is the simplest. Currently there are no dialysers on the market in Europe which retain the use of unmodified cellulose membrane (Cuprophan). Economic evaluations showed the cost of self-mix bicarbonate buffer to be similar to that of acetate. Ultrapure dialysis fluid is produced by ultrafiltration of dialysis fluid in dialysis machines and is used as an on-line substitution fluid in convective therapies such as HDF or haemofiltration. Substitution of sodium acetate for sodium bicarbonate in the bath fluid for hemodialysis. Guideline 3. A multivariate Cox proportional hazards analysis of a prospective non-randomised study of 1610 prevalent HD patients from 20 centres in France showed that age, diabetes, lower serum albumin and the use of low-flux dialyser membranes were associated with poorer survival (12). The pore size of the membrane appears to be less important than the thickness and the capacity of the membrane to adsorb bacterial products. Haemodiafiltration would be the preferred mode of extracorporeal renal replacement therapy in patients with established renal failure if it was shown in randomised controlled trials to provide better patient outcomes than high flux haemodialysis. Increased interest in the UK is being shown in the NxStage machine which uses lactate as a buffer and cannot be used with bicarbonate. When a particular model of a machine becomes obsolete, companies generally only undertake to supply replacement parts for seven years. Comparison of hemodialysis, haemodiafiltration and haemofiltration: systematic review or systematic error. Both treatments are thought to reduce the risk of developing dialysis-related amyloid. No. Audit of this patient-centred index of quality of HD provision has been reported in the Scottish HD population by Quality Improvement Scotland (QIS) (1). Design and statistical issues of the hemodialysis (HEMO) study. CD006258. The molecular weights of the solutes to be cleared by dialysis range over three orders of magnitude, from small (water, urea) to large (beta-2-microglobulin). The effect of dialyser membrane flux was examined in the HEMO study, which was a prospective randomized trial of prevalent HD patients who had been on dialysis for a median of 3. Therefore UKM requires collection of additional data on dialyser clearance, an interdialytic urine collection for measurement of urea concentration and volume, and measurement of pre-dialysis urea concentration on the subsequent dialysis. 1 - HD: Minimum frequency of haemodialysis per week We recommend that HD should take place at least three times per week in nearly all patients with established renal failure. National Kidney Foundation. About 40% of patients starting renal replacement therapy (RRT) before the millenium were referred as late uraemic emergencies with no time for the planning of, or counseling on, the options for dialysis, and such patients are more likely to remain on HD (2,3) but late referral had fallen to 21% in 2007 (1). Inflammation enhances cardiovascular risk and mortality in hemodialysis patients. 1 - 5. Intensive use of HD machines for three 4 hour shifts per day, 6 days per week would complete 26208 hours of use after 7 years. Glucose-added dialysis fluid prevents asymptomatic hypoglycaemia in regular haemodialysis. This approach is designed to promote a progressive increase in the achievement of audit measures in parallel with improvements in clinical practice. Comparison between unmodified cellulose and modified cellulose membranes was not undertaken. Maybe that workout can wait till the weekend What to eat before, during, and after a workout Eat Mediterranean diet for a healthier and younger brain Does a vegan diet affect your ability to heal. Clinical use increased with the subsequent discovery that a number of these membranes (e. The manufacturer or supplier of a complete water treatment system should recommend a system that is capable of meeting the above requirements based on a feed water analysis and allowing for seasonal variation in feed water quality. The laboratory tests required to demonstrate compliance with the recommendations for monitoring of chemical contamination of dialysis water should be carried out during commissioning and thereafter monthly or following alterations to the water treatment plant. Ebo DG, Bosmans JL, Couttenye MM, Stevens WJ. About 10 years ago, several in vitro studies showed that intact membranes used in dialysers are permeable to bacterial contaminants (1-3). Terms of Use Privacy Policy AdChoices Advertise with us About us Newsletters Work for us Help Transcripts License Footage CNN Newsource. Lack of local HD provision and the inadequacy of patient transport services are the commonest concerns cited by HD patients and Kidney Patient Associations. Haemodialysis (HD) (Guidelines 5. Plasma triglyceride values were lower with synthetic membranes in the single study that measured this outcome in this systematic review but a subsequent randomized study has shown no difference in serum lipid levels in the patient group treated with high-flux biocompatible membranes (3). Table 3: Maximum allowable concentrations of chemical contaminants in dialysis water which only require monitoring when indicated. 6 The dialysis membrane was regarded as an effective barrier against the passage of bacteria and endotoxin (potent pyrogenic materials arising from the outer layers of bacterial cells) from dialysis fluid to blood. 5) Guideline 4. Many patients are maintained by HD after failure of renal transplants or because they have had to abandon PD. Depressant action of acetate upon the human cardiovascular system. European Best Practice Guidelines for haemodialysis Part 1. Induction of IL-1 during hemodialysis: transmembrane passage of intact endotoxins (LPS). 1 - 5. Renal units should endeavour to adopt a programme of phased replacement of older HD machines. These conditions have been shown to give good recovery for most environmental bacteria found in purified water. Audit measure 4 The number of haemodialysis stations expressed as a ratio of the total number of HD patients. Serum B2-microglobulin is a significant predictor of mortality in maintenanace haemodialysis patients. Trends in adult renal replacement therapy in the UK: 1982-2002. Chronic inflammation in hemodialysis: the role of contaminated dialysate. the current edition of the European Pharmacopoeia does not explicitly specify maximum allowable levels for copper or chloramines. The second generation formula validated and reported by Daugirdas is recommended (12). In summary the MPO study (6) and post hoc analysis of the HEMO study (4) provide evidence that long-term HD patients have better survival with the use of high flux dialysers and support the routine use of high flux instead of low flux dialysers. Testing for chemical contaminants will normally include continuous conductivity monitoring of the water leaving the reverse osmosis system, and regular in-house checks of hardness and total chlorine (5). A number of clinical studies have shown that the use of ultrapure dialysis fluid is associated with a range of clinical benefits (7-10). In elderly and diabetic patients higher insulin levels coupled with the higher glucose levels impair potassium removal during HD. Innovations and changes in HD practice have seldom been underpinned by adequately powered randomised trials. Ultrapure dialysis fluid slows loss of residual renal function in new dialysis patients. Each unit should have standard operating procedures in place for sampling, monitoring and recording of feed and product water quality. This can be achieved by using a high blood flow rate and regular flushing of the extracorporeal circuit with saline every 15-30 minutes or regional citrate infusion. Each unit should have standard operating procedures in place for sampling, monitoring and recording of feed and product water quality. Up to top 4. Using geographical information systems to plan dialysis facility provision. Effect of membrane permeability on survival of haemodialysis patients. Current proportionating systems incorporate filters for the removal of such fragments on the basis of size exclusion and hydrophobic interaction. Twice per week HD is no longer regarded as adequate and should be avoided. Hyperglycaemia also activates inflammatory pathways and contributes to the pro-inflammatory state of HD patients. Post-dialysis blood samples should be collected by the stop-dialysate flow method or, alternatively, the slow-flow or the simplified stop-flow methods may be used. Its use for HD has been associated in the short term with lower indices of inflammatory response (serum CRP and IL-6), in the medium term with better preservation of residual renal function, nutritional status and correction of anaemia and in the longer term may reduce the risk of complications due to dialysis-related amyloidosis. The J-DOPPS research group failed to show any effect of the biocompatibility or membrane flux of the dialyser on all-cause mortality or control of anaemia in Japanese HD patients treated by non-reuse dialysis (10). In some dialysis units up to 100% of treatments are performed with such techniques. It should be emphasised that the adsorption capacity of the synthetic membranes is not infinite and that a breakthrough of pyrogenic substances can occur in the event of excessive water contamination. What determines geographical variation in rates of acceptance onto renal replacement therapy in England. Bacterial contamination of hemodialysis center water and dialysate: are current assays adequate. Regional and national audit of HD capacity will highlight if there is inequity of access to HD and provide support for the development of HD facilities in such geographical areas. Anaphylactoid reactions in dialysis patients: role of ethylene oxide. (1C) Guideline 3. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Updates: Haemodialysis Adequacy, Peritoneal Dialysis Adequacy and Vascuar Access. ART. In water treated by reverse osmosis, these contaminants will only exceed the limits in Table 2 if they occur at relatively high levels in the water supplied to the unit. 3 - HD: Anticoagulation in patients with HIT type 2 or HITTS We suggest that patients with HIT type 2 or HITTS should not be prescribed unfractionated heparin or low molecular weight heparin (LMWH) (2B). European Best Practice Guidelines for haemodialysis Part 1. For example provision for an average of 314 hospital HD patients (or 79 stations) per million catchment population at the end of 2007 could be regarded as a minimum HD capacity in all regions in 2009. A study in Turkey comparing outcomes between on-line HDF and high flux HD in 780 patients over a 2 year period is due to be completed in March 2010 (8) and the results will be of great clinical interest as HDF is being compared directly with high flux HD, which is considered to be the optimal mode of standard HD. Although it is possible to keep a dialysis machine operating safely for many years, practical considerations of obsolescence and maintenance costs require a more structured approach. A programme of improvement should begin immediately if routine monitoring demonstrates that concentrations of chemical contaminants exceed the maximum allowable limits. 1% of the estimated 746 prevalent adult established renal failure patients per million population were receiving hospital HD and only 1. Better local access to HD can only be achieved if there are improvements in patient transport as well as the development of an extensive network of HD facilities. 6 - HD: Haemodialyis facilities We suggest that the required number of haemodialysis stations should be based on using each station for 2 patients per day three times per week. However these drawbacks are not important if the main aim of measuring small solute removal by HD is to ensure that a minimum target dialysis dose is delivered consistently. These data should be obtained from the municipal water supplier, or from tests on the raw water if it is obtained from a private source. However, there has been a recent report of patient exposure following inadequate removal of organic chemicals in the preparation of dialysis water (4). Schindler R, Beck W, Deppisch R, Aussieker M, Wilde A, Gohl H, Frei U. The complete water treatment, storage and distribution system should meet the requirements of ISO 26722 (6) and be shown to be capable of meeting the requirements of ISO 13959 (2) at the time of installation (7). It is therefore essential that the water used to produce dialysis fluid is of an appropriate chemical and microbiological purity. QJM 2005: 98: 21-28 Guideline 1. polysulphone, polyamide, polyacrylonitrile) had markedly less ability to activate complement, leucocytes and other cellular elements than standard cellulose and hence decrease the inflammatory response. Theoretically, reductions in sessional dialysis time can be more safely pursued if there is a concomitant improvement in middle molecular (MM) clearance, a goal which cannot be achieved by high blood flow rate or dialysis fluid flow rate and large surface areas of membranes impermeable to middle molecules. High flux HD membranes remove beta-2-microglobulin by a combination of diffusive clearance and adsorption and haemodiafiltration removes substantially more as a result of convective clearance. The microbiological contaminant levels of ultrapure dialysis fluid should be Guideline 3. Lychee identified as cause of mysterious disease plaguing Indian town Transgender Americans rush to prepare for Trump era Is this ancient, bag-like sea creature our earliest ancestor. Haemodiafiltration would be the preferred mode of extracorporeal renal replacement therapy in patients with established renal failure if it was shown in randomised controlled trials to provide better patient outcomes than high flux haemodialysis. The reports of the UK Renal Registry, Scottish Renal Registry and NHS Quality Improvement Scotland have demonstrated the benefits of performing regular audit to improve clinical standards in HD. The clinical utility of super flux dialysers which provide even greater removal rates of beta-2-microglobulin remains uncertain (15). Schindler R, Christ-Kohlrausch F, Frei U, Shaldon S. New water treatment systems have the capability of producing water suitable for the production of ultrapure dialysis fluid but the fluid requires further treatment if it is to be used as infusion fluid in convective therapies. 7 - HD: Monitoring of feed and dialysis water for haemodialysis We recommend that a routine testing procedure for water for dialysis should form part of the renal unit policy. 4 - 3. Microbial contamination may be enhanced by stagnant areas within the distribution network or irregular cleaning. In vitro study of the transfer of cytokine inducing substances across selected high flux hemodialysis membranes. In view of this interaction the ACE inhibitor should be changed to an angiotensin II antagonist in patients starting dialysis with a synthetic membrane which is capable of generating bradykinin. Consequently clinical practice guidelines for HD have been developed in Australasia, Canada, Europe and the USA (2-5) as well as the UK. Zimmermann J, Herrlinger S, Pruy A et al. Overview of clinical studies in haemodiafiltration: what do we need now. At present there is no data to support the use of haemofiltration or HDF instead of high flux HD in the management of end-stage chronic renal failure (10,11). Geographical variation in the referral of patients with chronic end-stage renal failure for renal replacement therapy. The URR is easy to perform and is the most widely used index of dialysis dose used in the UK. Cellulose, modified cellulose and synthetic membranes in the haemodialysis of patients with end-stage renal disease. Twice weekly HD as a long-term form of chronic renal replacement therapy should be discouraged. No specific recommendations regarding the frequency of monitoring are made but it should be performed at least monthly in respect of the product water and after any maintenance work on the water treatment system. Reduction in beta2-microglobulin with super flux versus high flux dialysis membranes: results of a 6-week randomised double-blind crossover trial. While there is general agreement concerning the maximum allowable levels of inorganic chemicals with documented toxicity in HD patients (aluminium, chloramines, copper, fluoride, lead, nitrate, sulphate, and zinc) there are some exceptions e. Equity of access to dialysis facilities in Wales. The frequency of monitoring of the feed (or raw water) quality may be performed less frequently. Verresen L, Fink E, Lemke HD, Vanrenterghem Y. The National Service Framework Part 1: Dialysis and Transplantation has stressed the need for a patient-centred approach in the planning and provision of renal replacement therapy with an emphasis on patient education and choice as well as the provision of adequate resources for elective access surgery, dialysis and transplantation (1). Moreover most respondents indicated they wished to have hard evidence of better patient outcomes, such as patient survival, before considering one form of dialysis to be superior to another and that improvements in surrogate markers was inadequate (12). References 1 Mion CM, Hegstrom RM, Boen ST et al. Guideline 7. (1B) Rationale The most powerful determinant of solute removal is dialysis frequency rather than duration. A clinical and cost evaluation of haemodialysis in renal satellite units in England and Wales. With the exception of nitrate, where the standards differ in their recommendations, the most stringent limit has been adopted. Preservation of residual renal function is desirable as residual renal function is a predictor of survival in HD patients (14), decreases beta-2-microglobulin levels and lessens the need for ultrafiltration. Consequently low flux (standard) dialysis does not necessarily translate into higher microbiological safety than high flux dialysis or HDF. It should be acknowledged if this cannot be achieved. Mortality risk for patients receiving haemodiafiltration versus hemodialysis: European results from the DOPPS. 10) Guideline 5. It also identified that a small proportion of patients after counseling may opt for optimal conservative medical therapy without planning to initiate dialysis.
Clinical Scientist, Renal unit, Freeman Hospital and Honorary Lecturer, Newcastle University Dr Cormac Breen. High volume HDF can therefore provide higher removal rates of all MM, phosphate and other small solutes. Rabindranath KS, Strippoli GF, Roderick P et al. Rationale Synthetic membranes, which can have more porous characteristics (high flux) than standard cellulose membranes, started to be used in the mid-1980s with a view to increasing the depurative capacity of HD. 10) Guideline 5. The provision of HD capacity within the UK has tended to lag behind patient demand and this has restricted both patient choice and access to hospital HD (4). Recommendations for the maximum allowable concentrations of chemical contaminants have been prepared by a variety of standard developing organisations, professional societies and pharmacopoeias, such as AAMI (1), International Standards Organisation (2) and the European Pharmacopoeia (3). A systematic review of 27 randomised trials comparing cellulose, modified cellulose and synthetic membranes, showed a significant reduction in end of study beta-2-microglobulin values when high flux synthetic membranes were used and one small study showed amyloid occurred less frequently with this treatment (1). Alternatively a different dialysis membrane may be used and the ACE inhibitor continued (3). Harding GB, Pass T, Million C, Wright R, DeJarnette J, Klein E. For home installations it may be impractical to maintain a monthly testing programme and to ensure adequate patient safety the dialysis machine should be fitted with point of use filtration. All dialysis units should collect and report this data to their regional network and the UK Renal Registry. The operating procedures should include details of the procedures to be followed if the prescribed limits are exceeded. The method used should remain consistent within renal units and should be reported to the Registry. Rabindranath KS, Strippoli GFM, Daly C et al. Osteocalcin and myoglobin removal in on-line haemodiafiltration versus low- and high-flux haemodialysis. In this setting addition of chemicals into the hospital water supply should not be undertaken without prior consultation with renal services. This produced a complacent attitude towards the purity of dialysis fluid. The acceptance rate for dialysis declines with increasing distance and travel time from the nearest dialysis unit and patients are less likely to be offered dialysis if the travel time from home to the dialysis unit is more than 37 minutes (1,2). UKM also may give valuable information on urea generation rate and protein catabolic rate. ISO 23500: Guidance for the preparation and quality management of fluids for haemodialysis and related therapies. Burmeister JE, Scapini A, da Rosa Miltersteiner D, da Costa MG, Campos BM. A wider distribution of small satellite HD units would help reduce the need to accept twice weekly HD for lifestyle reasons. Adequate clearance of the whole range of molecules by dialysis is important and in the future monitoring of beta-2-microglobulin levels may be used to assess dialysis adequacy. In inner city areas travel times over short distances may exceed 30 minutes at peak traffic flow periods during the day. Although lower beta-2-microglobulin concentrations are associated with lower all cause mortality (16) and lower infection related mortality (17) this asociation does not indicate causality with the use of high flux membranes as other factors such as the level of residual renal function, survival bias, use of ultrapure water or confounding co-morbidity may be implicated (16,17). (2C) Guideline 4. Since it does not precipitate calcium or magnesium, acetate was used as an alternative buffer (1) because of its rapid conversion to bicarbonate in the liver. European Best Practice Guidelines for haemodialysis Part 1. The BS EN 60601-2-16 standard for electrical equipment for renal replacement therapy was updated in 2008. 3184. The provision of dedicated or individualized HD patient transport services, which can avoid the need to collect and drop off other patients, and the use of staggered starting times for HD would help to reduce patient waiting times before starting and after completing dialysis. Cheung AK, Greene T, Leypoldt JK et al. Effect of high-flux dialysis on the anaemia of haemodialysis patients. Exposure to bio-incompatible membranes may increase beta-2-microglobulin generation. Dialyser membrane permeability and survival in hemodialysis patients. Comparison of hemodialysis, hemofiltration, and acetate free biofiltration for ESRD: systematic review. To reverse the inverse relationship between acceptance rates for HD and travel time to the nearest HD facility patients should not need to spend more than 30 minutes traveling to and from dialysis unless they live in a remote geographical area. This appears to have been unmasked by the introduction of high-efficiency and short-duration dialysis, using membranes with large surface areas. The microbiological contaminant levels for acid and bicarbonate concentrates are defined in BS ISO 13958 2009 Concentrates for haemodialysis and related therapies. (2C) Up to top 9. The degree of flexibility in HD capacity and scheduling then depends on the proportion of HD patients who are on a third shift each day (1). Other studies have shown improved survival (7) or no difference in survival (8) of diabetic patients treated with high flux membranes. (1B) Rationale Equity of access to HD is self evident in a patient-centred service. The provision of dialysis treatment at the 12 renal satellite units in the study potentially saved the HD patients an additional 19 minutes travel time for each dialysis session (5). URR does not take solute removal via ultrafiltration or residual renal function or urea generation during dialysis into account (5,6) and hence total urea removal can be significantly higher than predicted from the percentage reduction in blood urea. Section IV. The rationale for this omission is that organic chemicals with specific toxicity in HD patients have not been identified and that carbon adsorption and reverse osmosis removes most organic compounds. These guidelines serve to identify and promote best practice in the delivery of HD and have set clinical standards to allow comparative audit of the key aspects of the HD prescription, laboratory data and patient outcomes. The more biocompatible membranes may have other advantages as a result of reduced activation of the systemic inflammatory response during dialysis but this is less certain (1). There is currently no guidance on the control and monitoring of chlorine dioxide in water for dialysis. 4 - HD: Anticoagulation and catheter lock solutions We suggest that each unit should have policies and procedures for administration of catheter locking solutions to maintain catheter patency and keep systemic leak of the catheter lock solution to a minimum. If, however, sodium bicarbonate is added to a calcium- or magnesium-containing dialysate, their respective carbonate salts will precipitate unless the dialysate is maintained at a low pH level. The proven benefits of low flux synthetic and modified cellulose membranes over unmodified cellulose membranes are limited to advantages arising from different aspects of improved biocompatibility rather than better patient outcomes. Furuya R, Kumagai H, Takahashi M, Sano K, Hishida A Ultrapure dialysate reduces plasma levels of beta2-microglobulin and pentosidine in hemodialysis patients. Acetate intolerance led to the reappraisal of bicarbonate as a dialysis buffer in the early 1980s and, following the solving of the issue of precipitation, to its reintroduction. A survey of nephrologists opinion showed that high flux HD was the preferred mode of RRT in the USA and Asia and high volume HDF was the most common therapy of choice in Europe (12). HD was the established mode of dialysis at 90 days in 67. 4% of the UK patient cohort in 2007 compared with 59% in 1998 (1). Impure dialysis fluid has also been implicated in the pathogenesis of dialysis-related amyloidosis and an increased rate of loss of residual renal function. Some of these patients therefore may not be medically suitable for treatment at a local satellite HD unit and may need to travel further to a main renal unit for dialysis. Detailed procedures for the collection and analysis of samples of water and dialysis solution for microbiological analysis also form part of ISO 23500. Impact of the type of dialyser on clinical outcome in chronic haemodialysis patients: does it really matter. Meeting the need for HD will be a major challenge and regular audit should be used to raise HD capacity across the UK in step with the projected increase in demand over the next decade. It is not possible to set evidence-based standards for other components of the dialysate. There is also a French study underway comparing dialysis tolerance in 600 patients randomised to either HDF or high flux HD (9). 7 years at the time of recruitment to the study (2,3). (2C) Up to top 2. One small prospective study has shown better preservation of residual renal function when using high flux membranes combined with ultrapure water (13). In the late 1970s and early 1980s, a number of studies suggested that some of the morbidity associated with HD could be attributed to the acetate component of the dialysate (2,3). The location of satellite units should provide maximum geographic access to patients within the local catchment population and a centre of population based approach has been used in the planning of small satellite HD units in some regions of the UK (7). Considerable differences exist in the adsorption capacity of such membranes, which may permit the passage of short bacterial DNA fragments (2-4). 8 - HD: Haemodialysis post-dialysis blood sampling We recommend the use of a standardised method of post-dialysis blood sampling. (1B) Guideline 5. Can we improve early mortality in patients receiving renal replacement therapy. Twice weekly HD effectively means that the patient will require longer duration HD, usually at least 6 hours twice per week. Dialysis-related amyloidosis is a disabling, progressive condition caused by the polymerisation within tendons, synovium, and other tissues of beta-2-microglobulin, a large (molecular weight (MW) 11,600) molecule, which is released into the circulation as a result of normal cell turnover but is not excreted in renal failure and is not removed by cellulose membranes. Guidelines for the control and monitoring of microbiological contamination in water for dialysis. Provision of designated parking adjacent to the dialysis area would encourage patients to organize their own transport to and from dialysis and so reduce the need for hospital provision of patient transport. Differences in the permeability of high-flux dialyzer membranes for bacterial pyrogens. g hemophan or cellulose triacetate), and synthetic membranes with lower flux properties have also been produced (e. Hypoglycaemia is not observed if the dialysate contains glucose, but glucose-containing dialysate is slightly more expensive. The dialysis membrane prevents transmembrane passage of intact bacteria but bacterial fragments have molecular weights that allow them to pass across the membrane into the bloodstream. Regional differences in the provision of adult renal dialysis services in the UK. The microbiological contaminant levels of ultrapure dialysis fluid should be Rationale for 3. 6% of new patients between 1990 and 1996. For example, the reduction ratios of beta-2-microglobulin after HDF were 75%, after high flux HD were 60% and after low flux HD were 20% (1). This approach should drive the provision of HD upwards in the areas with below average HD capacity. The Cross Party Group on Kidney Disease Report, 2004 reinforces this point since it identified that 49% of HD patients in Scotland had travel times in excess of 30 minutes even though only 10% patients lived more than a 30 minute drive from the nearest HD facility (8). Results from an international survey among nephrology professionals. g. Audit measure 2 The waiting time after arrival before starting dialysis and the waiting time for patient transport after the end of haemodialysis. (1B) Rationale One of the critical functions of dialysis is the correction of the metabolic acidosis caused by the failure of the diseased kidneys to excrete non-volatile acids and to regenerate bicarbonate. Locatelli F, Andrulli S, Pecchini F et al. Audit measure 3 The number of haemodialysis patients in the main renal unit and its satellite units expressed per million catchment population. This module provides an update of the 2007 RA clinical practice guidelines in HD and, most importantly, modification of the current guidelines whenever indicated by evidence from new studies. Some patients who live at far distances from a HD unit remain on twice weekly HD and this small subgroup of patients should be kept to a minimum and receive much longer duration sessions. Specialised, fully funded transport for dialysis patients is the gold standard and should be developed to facilitate timely transport by car or ambulance to meet these guidelines. The presence of microbial contamination contributes to the development of biofilm which may also be found in the dialysate pathway of the proportionating system, particularly when non-sterile liquid bicarbonate concentrate is used. Such reactions are triggered by negatively charged biomaterials such as Polyacrylonitrile (AN69) capable of activating factor XII, leading to the generation of bradykinin. The HEMO study was designed to have adequate power to detect a 25% reduction in the predicted baseline all cause mortality rate with the interventions (5). Roderick P, Nicholson T, Armitage A et al. Such biofilm is difficult to remove and results in the release of bacteria and bacterial fragments (endotoxins, muramylpeptides, and polysaccharides). g. HD is also the default therapy for all end stage renal disease (ESRD). This study has confirmed that HD in a satellite unit is an effective alternative to treatment in a main renal unit and provides support for a national network of HD facilities with adequate capacity to enable all medically suitable patients to receive chronic HD without having routine travel times in excess of 30 minutes. Its use allows accurate prediction of the effects of changing one particular component of the dialysis prescription (eg dialyser size, dialysis duration, blood flow rate) on the delivered dialysis dose although this benefit has been overstated given the limited number of practical options for changing the dialysis prescription. Grading evidence and recommendations for clinical practice guidelines in nephrology. A position statement from Kidney Disease Improving Global outcomes (KDIGO). The development of patient transport services that avoid the need to collect and drop off other patients at the dialysis centre or at other healthcare facilities would help keep travel times to a minimum. Synthetic and modified cellulose dialysers are now no more expensive than unmodified cellulose dialysers and the use of these more biocompatible dialysers instead of unmodified cellulose therefore seems justifiable on the basis of evidence of biological benefits and equivalent costs. Grading quality of evidence and strength of recommendations. BS ISO 13958 2009 Concentrates for haemodialysis and related therapies. 8 - HD: Bicarbonate dialysate for haemodialysis We recommend that the dialysate should contain bicarbonate as the buffer. The national average number of hospital HD patients per million catchment population reported for the previous year by the UK Renal Registry may be regarded as the minimum capacity for HD in each geographically based renal service. Audit measure 5 The proportion of patients in the main renal unit and its satellite units who are on twice weekly haemodialysis. Rationale The routine maintenance of the equipment used for renal replacement therapy is essential and the service history of each machine should be documented fully throughout its use-life by the renal unit technicians. Bicarbonate is the natural buffer normally regenerated by the kidneys and was the initial choice as dialysate buffer. These contaminants can be omitted from routine tests if data is available to show that the levels in the water supplied to the unit rarely exceed the limit in the table. In house produced concentrates should also meet the requirements of BS ISO 13958 2009 or the requirements stated in the European Pharmacopoeia (6th edition, 2007). Relative contribution of residual renal function and different measures of adequacy to survival in hemodialysis patients: an analysis of the Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD)-2. Reduction of dialysis frequency to twice per week because of insufficient dialysis facilities is unacceptable. Prescribed concentrations and values. 3 - HD: Chemical contaminants in water used for the preparation of dialysis fluid We recommend that the concentrations of chemical contaminants in water used to prepare dialysis fluid should not exceed the limits stated either in BS ISO 13959 2009 Water for haemodialysis and related therapies or in the European Pharmacopoeia (6th edition, 2007). There is increasing use of chlorine dioxide to prevent growth of Legionella bacteria in hospital water systems. However a systematic review of the existing 18, albeit mainly small, randomized trials in 2005 showed no difference in patient outcomes between HD, HDF and haemofiltration (2). DOI. The prevalence rate of HD patients was significantly lower in the areas of Wales with travel times greater than a 30 minute drive to the nearest current dialysis unit (3). (2C) Up to top 8. Convestion versus diffusion in dialysis: an Italian prospective multicentre study. The operating procedures should include details of the procedures to be followed if the prescribed limits are exceeded. After the first 3 years of dialysis 3% of the 1998-2000 cohort of HD patients in the UK had converted to peritoneal dialysis, mostly within the first year, whereas almost 11% of the PD patients had switched to HD each year. It is estimated that there are more than 1. Culture of dialysis fluids on nutrient-rich media for short periods at elevated temperatures underestimate microbial contamination. In patients who are restless or undergoing haemodialysis at home consideration should be given to the use of commercially available monitoring systems. Goldwasser P, Mittman N, Antignani A et al. In patients treated with high flux membranes, a risk of pyrogen transfer due to backfiltration (a movement of dialysis fluid into the blood pathway of the device due to an inverted pressure gradient rather than the diffusion gradient discussed above) may exist. This approach allows for patient choice regarding haemodialysis schedules, more frequent dialysis schedules, provision of holiday haemodialysis and expansion in patient numbers. Small satellite units should be established also in rural areas or islands to provide more local access to HD and permit travel distances or times that make thrice weekly HD acceptable to patients. A raised C-reactive protein (a sensitive marker of activation of the acute phase response) is associated with a significantly increased risk of death (5,6) and has led to speculation that micro-inflammation associated with transmembrane transfer of endotoxins and bacterial fragments may contribute to raised serum levels of CRP in patients undergoing regular HD. 8 - HD: Bicarbonate dialysate for haemodialysis We recommend that the dialysate should contain bicarbonate as the buffer. for HEMO Study Group. Nevertheless, day-to-day clinical decisions on HD are required and standards need to be set on the best available evidence. The frequency of twice weekly dialysis has decreased world wide, including in the USA where it fell from 12. These trace elements are not considered to occur in levels that give cause for concern and, if low levels are present, they are removed effectively by reverse osmosis. There should be great emphasis on teamwork, quality assurance and audit, health and safety and continuing professional development for all members of the multidisciplinary team (2). (1B). Predilution hemofiltration displays no hemodynamic advantage over low-flux hemodialysis under matched conditions. Modern dialysis machines permit the production of substitution fluid on site and on-line allowing large reinfusion volumes to be used. NHS Quality Improvement Scotland has adopted 30 minutes as the maximum routine travel time to and from HD facilities in Scotland except in remote areas (4) but this guideline may be viewed as impractical in some urban areas because of transport delays due to traffic congestion. The USA (NKF-KDOQI) and European (EBPG) guidelines on HD have also been updated (2,3) and standardisation with these and other international guidelines on HD has been attempted whenever possible. Planning, Initiating and Withdrawal of Renal Replacement Therapy. However there is recent evidence that non-diabetic HD patients using glucose-free dialysate have a surprisingly high rate of asymptomatic hypoglycaemia without an associated counter-regulatory response (6,7) The long-term effects of repeated dialysis-induced hypoglycaemia are uncertain. This guideline promotes the adoption of a range of standardized audit measures in HD and the proportions of patients who should achieve clinical and laboratory performance indicators have not been specified for most of the clinical practice guidelines. Records should be kept of all chemical and microbiological test results and remedial actions (1). Lonneman et al, however, concluded that diffusion rather than convection is the predominant mechanism of transmembrane transport of pyrogens, and backfiltration across pyrogen adsorbing membranes does not necessarily increase their passage (4). The absence of any type of bacteriostat in the water following treatment makes it susceptible to bacterial contamination downstream of the water treatment plant. Biocompatibility and permeability of dialyzer membranes do not affect anaemia, erythropoietin dosage or mortality in Japanese patients on chronic non-reuse haemodialysis: a prospective cohort study from J-DOPPS II study. Bradykinin is a mediator of anaphylactoid reactions on AN69 membranes in patients receiving ACE inhibitors. Short bacterial DNA fragments: detection in dialysate and induction of cytokines. Haemodynamic variables were found to be similar in a further recent study comparing HDF and low-flux HD under conditions of equivalent dialysis dose, ultrafiltration volume and core temperature (4). (1C) Guideline 5. Laude-Sharp M, Caroff M, Simard L et al. Tables 1-3 list all the contaminants for which a maximum allowable limit is defined for water for dialysis in one or more of the standards. The proven benefits of high flux synthetic membranes in randomized trials arise from improved biocompatibility and enhanced removal of middle molecules, such as beta-2-microglobulin, rather than better patient survival rates. Evidence of improved patient survival with the use of high flux membranes is restricted to incident patients, who have lower serum albumin concentrations ( Rationale Treatments with better clearance of middle molecules include haemodialysis with high flux synthetic membranes and haemodiafiltration. Effects of high-flux hemodialysis on clinical outcomes: Results of the HEMO study. Effect of membrane permeability on survival of hemodialysis patients. Cochrane Database of Systematic Reviews 2006, Issue 4. C-reactive protein as an outcome predictor for maintenance hemodialysis patients. 1 - HD: Minimum frequency of haemodialysis We recommend that HD should take place at least three times per week in nearly all patients with established renal failure. BS ISO 13958 2009 specifies the minimum requirements for concentrates used for HD and related therapies (1). Of note none of the standards and recommendations includes limits for specific organic chemical contaminants. Chronic inflammation and mortality in renal replacement therapies. 1% were on home HD at the end of 2007 (1). Association between serum B2-microglobulin level and infectios mortality in hemodialysis patients. Ultrapure dialysis fluid slows loss of residual renal function in new dialysis patients. g. Table 2 defines a group of contaminants for which the drinking water limit is 2 to 5 times the recommended limit for dialysis (5). An initial full test on the supply water may be advisable and regular monitoring of water quality data from the supplier is essential when tests are omitted based on low levels of contamination in the water supply. Normally this is rapidly degraded by serine proteinase kininase II but in the presence of ACE inhibition plasma bradykinin levels increase and can cause anaphylaxis (2). A multicentre, randomized controlled trial has failed to show a beneficial effect on anaemia in stable HD patients using a high flux biocompatible membrane compared with conventional cellulose membranes over a 12 week study period (11). The sections on vascular access and planning, initiation and withdrawal of renal replacement therapy in the 2007 version have been removed as two separate new modules have been developed to provide guidance on these key areas in the provision of high quality care in HD. The frequency of testing may be modified once local trends have been established, but should not fall below annually. Effectiveness and efficiency of methods of dialysis therapy for end-stage renal disease: systematic reviews. 42. UK Registry data from the end of 2007 showed that there were 314 patients per million population on hospital or satellite HD (1). Although the clinical benefit of ultrapure dialysis fluid has not been established in a large scale randomized trial it would seem prudent to ensure that water is as pure as reasonably possible and the European Best Practice Guidelines recommend the use of ultrapure water for all dialysis treatments (11). An evaluation of the costs, effectiveness and quality of renal replacement therapy provision in renal satellite units in England and Wales. Cellulose membranes have been modified to make them both more biocompatible and of slightly higher flux (semi-synthetic membranes e. Despite the success of transplantation and peritoneal dialysis (PD), HD continues to have the highest rate of growth of all treatment modalities. The module format has been designed to permit easy modification on the website to incorporate future changes in practice recommendations based on evidence from new research. Confirmation that the standard DPD test used to monitor chlorine and chloramines gives an accurate measure of the levels of chlorine dioxide and its breakdown products (chlorite and chlorates) is needed as is data on the carbon filter empty bed contact time that is required for the effective removal of these compounds. 5 million patients with established renal failure who are treated with HD. The microbiological contaminant levels for acid and bicarbonate concentrates are defined in BS ISO 13958 2009 Concentrates for haemodialysis and related therapies.
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