A Perspective on the Current Status of Home Hemodialysis.

Most hemodialysis (HD) in Japan is based on the central dialysis fluid delivery system (CDDS). With CDDS, there is an improvement in work efficiency, reduction in cost, and a reduction in regional and institutional differences in dialysis conditions. This has resulted in an improvement in the survival rate throughout Japan. However, as the number of cases with various complications increases, it is necessary to select the optimal dialysis prescription (including hours and frequency) for each individual in order to further improve survival rates. To perform intensive HD, home HD is essential, and various prescriptions have been tried. However, several challenges remain before widespread implementation of home HD can occur.

What is the optimum dialysate flow in post-dilution online haemodiafiltration?

INTRODUCTION: In post-dilution online hemodiafiltration (OL-HDF), the only recommendation concerning the dialysate, or dialysis fluid, refers to its purity. No study has yet determined whether using a high dialysate flow (Qd) is useful for increasing Kt or ultrafiltration-infusion volume. OBJECTIVE: Study the influence of Qd on Kt and on infusion volume in OL-HDF. MATERIAL AND METHODS: This was a prospective crossover study. There were 37 patients to whom 6 sessions of OL-HDF were administered at 3 different Qds: 500, 600 and 700ml/min. A 5008(®) monitor was used for the dialysis in 21 patients, while an AK-200(®) was used in 17. The dialysers used were: 20 with FX 800(®) and 17 with Polyflux-210(®). The rest of the parameters were kept constant. Monitor data collected were effective blood flow, effective dialysis time, final Kt and infused volume. RESULTS: We found that using a Qd of 600 or 700ml/min increased Kt by 1.7% compared to using a Qd of 500ml/min. Differences in infusion volume were not significant. Increasing Qd from 500ml/min to 600 and 700ml/min increased dialysate consumption by 20% and 40%, respectively. CONCLUSIONS: With the monitors and dialysers currently used in OL-HDF, a Qd higher than 500ml/min is unhelpful for increasing the efficacy of Kt or infusion volume. Consequently, using a high Qd wastes water, a truly important resource both from the ecological and economic points of view.

The present status of and perspectives on home hemodialysis therapy in Japan.

Home hemodialysis (HHD) is one of the best choices for improving the quality of life and survival rate of dialysis patients because it can lead to longer and more frequent dialysis programs to aid in achieving adequate dialysis. There were 461 dialysis patients treated with HHD as of the end of 2013 in Japan, comprising only 0.1% of all dialysis patients in this country. Although this is a very small expansion rate, the number of HHD patients has been rapidly increasing in recent years. The Japanese Society for Home Hemodialysis was established in 1998 and formed the following 3 working groups to survey various problems underlying current HHD: Patient Registry, Supply and Waste, and Self-pay Burden. In order to achieve a successful HHD program in Japan, there are several issues to be resolved, including the development of standard recruitment and education programs, optimization of the composition of dialysis fluid, sufficient reimbursement for HHD, and the establishment of a business model for HHD similar to that for peritoneal dialysis.

Economic evaluation of neutral-pH, low-glucose degradation product peritoneal dialysis solutions compared with standard solutions: a secondary analysis of the balANZ Trial.

BACKGROUND: Biocompatible solutions may lower peritonitis rates, but are more costly than conventional solutions. The aim of the present study was to assess the additional costs and health outcomes of biocompatible over conventional solutions in incident peritoneal dialysis patients to guide practice decisions. STUDY DESIGN: Secondary economic evaluation of a randomized controlled trial. SETTING & POPULATION: 185 participants in the balANZ trial. MODEL, PERSPECTIVE, & TIMEFRAME: Cost-effectiveness of biocompatible compared to standard solution over the 2 years using an Australian health care funder perspective. INTERVENTION: Intervention group received biocompatible solutions and control group received standard solutions over 2 years. OUTCOMES: Costs included dialysis charges, costs of treating peritonitis, non-peritonitis-related hospital stays, and medication. Peritonitis was the health outcome of interest; incremental cost-effectiveness ratios were reported in terms of the additional cost per additional patient avoiding peritonitis at 2 years. RESULTS: Mean total per-patient costs were A$57,451 and A$53,930 for the biocompatible and standard-solution groups, respectively. The base-case analysis indicated an incremental cost of A$17,804 per additional patient avoiding peritonitis at 2 years for biocompatible compared to standard solution. In a sensitivity analysis excluding extreme outliers for non-peritonitis-related hospitalizations, mean per-patient costs were A$49,159 and A$52,009 for the biocompatible and standard-solution groups, respectively. Consequently, the incremental cost-effectiveness ratio also was reduced significantly: biocompatible solution became both less costly and more effective than standard solution and, in economic terms, was dominant over standard solution. LIMITATIONS: Peritonitis was a secondary outcome of the balANZ trial. Health outcomes measured only in terms of patients avoiding peritonitis over 2 years may underestimate the longer term benefits (eg, prolonged technique survival). CONCLUSIONS: Biocompatible dialysis solutions may offer a cost-effective alternative to standard solutions for peritoneal dialysis patients. Reductions in peritonitis-related hospital costs may offset the higher costs of biocompatible solution.

The cost of alkaline solutions in ambulatory hemodialysis: an analysis about wasteful from the processes control.

INTRODUCTION: There are few studies about costs of inputs used in hemodialysis and among these expenditures, the compounds that make up the dialysate are one of the values considered as representative of this therapy. However, there aren't costs studies that guiding solutions. OBJECTIVE: The objective of this article is discuss whether there is wasteful of alkaline solutions in ambulatory hemodialysis and hence the possibility of reduction in cost from the standardization process simulation of establishment of dialysate flow in periods between shifts in hemodialysis outpatients. METHODS: Starting from an observational analytic, a simulation was performed twenty case scenarios, which ten cases established by standardizing processes control on the dialysate flow in recession. The combination of data was performed using as a basis the prices of three suppliers of alkali liquid or powder. RESULTS: It was observed among the scenarios with standardized processes, ranging between 7.7% and 33.3% savings in the alkaline solution cost (powder or liquid), by reducing waste. CONCLUSION: It is possible to restrain the wasteful use of alkaline solutions, both powder and liquid. Consequently, its cost from the patterning on reducing the flow of dialysate during the intervals between shifts observed in the outpatient hemodialysis. However, these results are conditional upon the commitment of health professionals, mainly to supervision exercise and control of activities in quality function deployment.

Bioenergetic gain of citrate anticoagulated continuous hemodiafiltration--a comparison between 2 citrate modalities and unfractionated heparin.

PURPOSE: To determine bioenergetic gain of 2 different citrate anticoagulated continuous hemodiafiltration (CVVHDF) modalities and a heparin modality. MATERIALS AND METHODS: We compared the bio-energetic gain of citrate, glucose and lactate between 29 patients receiving 2.2% acid-citrate-dextrose with calcium-containing lactate-buffered solutions (ACD/Ca(plus)/lactate), 34 on 4% trisodium citrate with calcium-free low-bicarbonate buffered fluids (TSC/Ca(min)/bicarbonate), and 18 on heparin with lactate buffering (Hep/lactate). RESULTS: While delivered CVVHDF dose was about 2000 mL/h, total bioenergetic gain was 262 kJ/h (IQR 230-284) with ACD/Ca(plus)/lactate, 20 kJ/h (8-25) with TSC/Ca(min)/bicarbonate (P < .01) and 60 kJ/h (52-76) with Hep/lactate. Median patient delivery of citrate was 31.2 mmol/h (25-34.7) in ACD/Ca(plus)/lactate versus 14.8 mmol/h (12.4-19.1) in TSC/Ca(min)/bicarbonate groups (P < .01). Median delivery of glucose was 36.8 mmol/h (29.9-43) in ACD/Ca(plus)/lactate, and of lactate 52.5 mmol/h (49.2-59.1) in ACD/Ca(plus)/lactate and 56.1 mmol/h (49.6-64.2) in Hep/lactate groups. The higher energy delivery with ACD/Ca(plus)/lactate was partially due to the higher blood flow used in this modality and the calcium-containing dialysate. CONCLUSIONS: The bioenergetic gain of CVVHDF comes from glucose (in ACD), lactate and citrate. The amount substantially differs between modalities despite a similar CVVHDF dose and is unacceptably high when using ACD with calcium-containing lactate-buffered solutions and a higher blood flow. When calculating nutritional needs, we should account for the energy delivered by CVVHDF.

Novel peritoneal dialysis solutions--what are the clinical implications?

Novel low-glucose degradation products (GDP) peritoneal dialysis (PD) fluids have an improved biocompatibility profile as compared to standard fluids. Clinical studies suggest that their use may be associated with favorable clinical outcomes; however, large prospective randomized studies addressing clinical endpoints such as patient and technique survival are presently lacking. Nevertheless, as their only disadvantage is their cost, they are already being used as the standard treatment by many adult PD centers. This policy is also in line with the latest recommendations from the European Pediatric Dialysis Working Group which advises that conventional, single-chamber PD solutions should be replaced by PD solutions with reduced GDP content. The use of icodextrin, the glucose polymer PD solution, is recommended for patients with high or high-average peritoneal transport and/or ultrafiltration problems who otherwise would resort to hypertonic (3.86% glucose) exchanges.

Costs and added value of haemodialysis and peritoneal dialysis outsourcing agreements.

BACKGROUND: Despite the discrepancy in results from Spanish studies on the costs of dialysis, it is assumed that peritoneal dialysis (PD) is more efficient than haemodialysis (HD). OBJECTIVES: To analyse the costs and added value of HD and PD outsourcing agreements in Galicia, the medical transport for HD and the relationship between the cost of the agreement and the cost of consumables used in continuous ambulatory peritoneal dialysis (CAPD) with bicarbonate. METHODS: The cost of the outsourcing agreements and the staff was obtained from official publications. The cost of PD and medical transport were calculated using health service data for one month and extrapolating it to one year. The cost of CAPD consumables was provided by the suppliers. The added value was calculated from the investments generated for each agreement treating 40 patients. RESULTS: Expressed as patient/year, the mean costs for treatment were €21595 and €25664 in HD and PD, respectively. Medical transport varied between €3323 and €6338, while those of the CAPD agreement and consumables were €19268 and €12057, respectively. The added value was greater with the HD agreement, especially considering the jobs created. CONCLUSIONS: One cannot generalise that the cost of PD, which is significantly influenced by prescriptions, is lower than that of HD. It would be appropriate to review the additional cost to consumables in the CAPD agreement. The added value generated by dialysis agreements should be considered in future studies and in health planning. More controlled studies are needed to better understand this issue.

Medicare program; end-stage renal disease prospective payment system. Final rule.

This final rule implements a case-mix adjusted bundled prospective payment system (PPS) for Medicare outpatient end-stage renal disease (ESRD) dialysis facilities beginning January 1, 2011 (ESRD PPS), in compliance with the statutory requirement of the Medicare Improvements for Patients and Providers Act (MIPPA), enacted July 15, 2008. This ESRD PPS also replaces the current basic case-mix adjusted composite payment system and the methodologies for the reimbursement of separately billable outpatient ESRD services.

[Medical and economic evaluation of new peritoneal dialysis solutions]. / Evaluation médico-économique des nouvelles solutions en dialyse péritonéale.

Conventional peritoneal dialysis solutions are mostly bioincompatible in relationship with a low pH, a high glucose and glucose degradation products (GDP) concentrations inducing anatomical and functional peritoneal membrane alterations. Use of icodextrin solution instead of glucose hypertonic solution preserves peritoneal membrane minimizing glucose exposure and its peritoneal absorption. Physiological fluids with a neutral pH and less GDP seem to have a positive effect on residual renal function which declines more slowly when they are early prescribed, before highly damaged and sclerotic kidneys. Preliminary data show that patients and technique survivals are better when physiological solutions are used either for diabetic and non diabetic patients. However, these new solutions do not improve peritonitis rates except for bicarbonate solutions but this fact must still be confirmed by other studies. In spite of a higher cost, physiological solutions must be proposed mainly for patients with a low comorbidity index and a high life expectancy.

Quelantes del fósforo (P) en diálisis: eficacia y coste. Soluciones de diálisis peritoneal / No disponible

La prevalencia del consumo de sevelamer es alta, la mitad de los pacientes son tratados con este quelante sin calcio. Durante 2007 han aparecido dos trabajos randomizados que analizan la eficacia del sevelamer sobre las sales de cal-cio. El estudio más potente estadísticamente hablando no encuentra diferencias respecto a la mortalidad entre ambos grupos, sevelamer y sales de calcio, excepto en mayores de 65 años que es favorable al sevelamer. En el otro estudio con menos potencia estadística se observa una menor mor-talidad en el grupo tratado con sevelamer. Ambos estudios tienen varias deficiencias y oportunamente ese mismo año aparece el meta-análisis al respecto, concluyendo que no hay una evidencia significativa que demuestre una eficacia superior del sevelamer sobre las sales de calcio, por lo que no es recomendable la extensión generalizada de su uso, como quelante de primera línea. En determinadas situaciones clínicas se valorará su utilización. Respecto al coste/beneficio, al no tener evidencia de obtener mayores beneficios clínicos con el sevelamer que con las sales de calcio, la prudencia y moderación en su uso será necesaria por el alto coste/beneficio demostrado. Delo contrario contribuiremos a aumentar el gasto en estos pacientes ya de por sí muy elevado, con un coste de vida ganada por año de los más elevados en medicina. El coste/beneficio del sevelamer sigue siendo poco atractivo desde el punto de vista económico, aunque se excluya la diálisis y trasplante en estos enfermos (AU)

Sevelamer use has a high prevalence, and half of patients are treated with this non calcium binder. Two randomized studies appeared in 2007 that compared the efficacy of sevelamer over calcium salts. In the more statistically potent of the two studies, no differences were found in mortality between the sevelamer and calcium groups, except for a benefit in favor of sevelamer in patients older than 65 years. In the other less statistically potent study, lower mortality was observed in the sevelamer group. Both studies have various deficiencies and a timely meta-analysis of the two studies appearing that same year concluded that there was no significant evidence demonstrating a superior efficacy of sevelamer over calcium salts. Therefore, generalized extension of its use as a first-line binder is not recommended. However, its use can be assessed in specific clinical situations .With regard to the cost-benefit ratio, as there is no evidence that greater clinical benefits are obtained with sevelamer than with calcium salts, prudence and moderation in its use are needed because of the high cost/benefit ratio demonstrated. Otherwise, we will contribute to increasing the already very high treatment cost in these patients, with one of the highest costs per life year gained in medicine. The cost/benefit ratio of sevelamer remains unattractive from an economic point of view, even if dialysis and transplant are excluded in these patients (AU)

[The concept of ultrapure solution online production]. / Il concetto di produzione online di liquido ultrapuro.

Online preparation of dialysis fluid, i.e., continuous mixing and immediate use, was introduced in 1964 and has contributed significantly to the expansion of dialysis therapy through simplified handling, improved microbiology, and enhanced efficiency. Online prepared replacement solution for hemofiltration was shown to be clinically safe as early as 1978, but the implementation was delayed for 20 years because of regulatory conservatism. Online preparation of sterile and pyrogen-free solutions for infusion is based on the use of water and concentrates that are mixed and distributed in a hygienically designed and maintained flow path. Ultrafilters with known retention capacity are placed in strategic positions to remove bacteria and endotoxins, which gives a sterility assurance level of at least six magnitudes, as required by the pharmacopoeia for sterile products. Microbiologic testing of the fluid should be applied when designing, validating, and troubleshooting online systems but not for routine quality control, because it only gives retrospective information. Quality assurance has to be built into a system and the way it is operated. The use of ultrapure dialysate must be considered as a suitable option for all hemodialysis modalities. To achieve this goal, one must keep in mind that ultrapure dialysate and infusate result from a complex chain of production where ultra-purity and/or sterility of the final solution relies on the weakest or worst component of the chain. Online fluid preparation, when properly performed, is safe, simple, and cost-effective and enhances the efficiency as well as the biocompatibility of dialysis therapy.

An analysis of the effectiveness and benefits of peritoneal dialysis and haemodialysis using Nigerian made PD fluids.

Haemodialysis (HD) and peritoneal dialysis (PD) remains the cornerstone of management of patients with renal failure in developing countries as renal transplantation is just developing in most. Although both HD and PD are cost intensive, specific advantages and disadvantages have been identified with either of them. Comparative assessment of their effectiveness, benefits and cost will assist in providing a rational basis for preference of one or the other especially in third world countries where renal replacement therapy remains unaffordable and therefore relatively inaccessible to majority of patients. We therefore conducted this prospective randomised study to compare the effectiveness, benefits, cost and complications of acute or intermittent PD (IPD) and HD using locally manufactured PD fluids. Two groups of twenty patients with renal failure matched for age and clinical diagnosis were managed with IPD and HD and the effectiveness, costs and complications of both modalities compared. We found that both were comparably effective in the control of uraemia with significant reductions in the serum urea, creatinine and potassium from 29.2 +/- 7.2 mmol/L, 1693.7 +/- 580.5micromol/L and 4.8 +/- 1.2 mmol/L to 13.2 +/- 4.6 mmol/L, 796.0 +/- 458.0micromol/ L and 3.3 +/- 0.6 mmol/L respectively for IPD (P<0.05) and 34.4 +/- 9.0mmol/L, 1536.0 +/- 832.5 micromol/L and4.8 +/- 1.3 mmoV L to 14.6 +/- 7.5 mmol/L, 830.0 +/- 570.7 micromol/L and 3.9 +/- 0.8 mmol/L respectively for HD (P<0.05). In addition, there were significant improvements in serum bicarbonate in both groups. There was no significant difference in percentage reduction in serum urea, creatinine and serum potassium in both groups (P>0.05). However, HD managed patients required more blood transfusion (P<0.05). There were also comparably significant reductiohs in systolic, diastolic and mean arterial blood pressures in both groups (P<0.05). The costs of dialysis as well as the total cost of hospitalization were found to be significantly lower in patients managed with IPD (P<0.05). The commonest complication observed in patients managed with IPD was peritonitis while in patients managed with HD it was dialysis-induced hypotension. The clinical outcome was equally good in all the ARF patients as all of them recovered irrespective of the treatment modality; CRF patients did not fare as well with 37.5% mortality observed. We conclude that IPD and HD are effective renal replacement therapies with the former being significantly cheaper. IPD should be encouraged in our patients with ARF or acute exacerbation of chronic renal failure.

Cost savings from peritoneal dialysis therapy time extension using icodextrin.

Previous retrospective studies have reported that icodextrin may prolong peritoneal dialysis (PD) treatment time in patients with refractory fluid overload (RFO). Because the annual cost of PD therapy is lower than that of hemodialysis (HD) therapy in Australia, we prospectively investigated the ability of icodextrin to prolong PD technique survival in patients with RFO. We used a computer model to estimate the savings associated with that therapeutic strategy, based on annual therapy costs determined in a regional PD and HD costing exercise. Patients who met standard criteria for RFO and who were otherwise to be converted immediately to HD, were asked to consent to an open-label assessment of the ability of icodextrin to delay the need to start HD. Time to conversion to HD was measured. The study enrolled 39 patients who were followed for a mean period of 1.1 years. Icodextrin significantly increased peritoneal ultrafiltration by a median value of 368 mL daily. It prolonged technique survival by a mean period of 1.21 years [95% confidence interval (CI): 0.80-1.62 years]. Extension of PD treatment time by icodextrin was particularly marked for patients who had ultrafiltration failure (UFF, n = 20), defined as net daily peritoneal ultrafiltration < 1 L daily (mean extension time: 1.70 years; 95% CI: 1.16-2.25 years). Overall, annualized savings were US$3,683 per patient per year. If just the patients with UFF were considered, the savings increased to US$4,893 per year. Icodextrin prolongs PD technique survival in patients with RFO, permitting them to continue on their preferred therapy. In Australia, that practice is highly cost-effective, particularly in individuals with UFF.

The cost barrier to peritoneal dialysis in the developing world--an Asian perspective.

Countries in Asia vary significantly in culture and socioeconomic status. Dialysis costs and reimbursement structures are significant factors in decisions about the rates and modalities of renal replacement therapy. From our survey of Asian nephrologists conducted in 2001, a number of observations can be made. In many developing countries, the annual cost of continuous ambulatory peritoneal dialysis (CAPD) is greater than the per-capita gross national income (GNI). The median cost of a 2-L bag of peritoneal dialysis (PD) fluid is around US$5. The absolute cost of PD fluid among countries with significant differences in per-capita GNI actually varies very little. Thus, most renal failure patients can be expected to have problems accessing PD therapy in developing countries in Asia. In countries with unequal reimbursement policies for PD versus hemodialysis, a lack of incentive to prescribe PD also exists. Automated PD is nearly non existent in many developing countries in Asia. Some possible ways to reduce the cost barriers to PD in those countries include individual governments providing more public funding for treating dialysis patients; dialysate-producing companies reducing the cost of their products; physicians using appropriately smaller exchange volumes (3 x 2 L) in some Asian patients with smaller body sizes and with residual renal function; and reducing the complication rate for PD (for example, peritonitis) thereby reducing the costs required for treatment and hospitalization.

Automated on-line bicarbonate concentrate production: microbiological, chemical and economic benefits.

We all know that "bicarbonate dialysate" became the world wide used fluid for use in haemodialysis and related techniques. To prepare bicarbonate dialysate we actually have to use two separate concentrates: one containing sodium bicarbonate, solely or in combination with other electrolytes other than calcium, and a second concentrate containing mostly all the other electrolytes (sodium, magnesium, potassium, chloride and/or some acetate).