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Abstract INTRODUCTION AND AIMS: There is currently no consensus about the indications for therapeutic apheresis, also due to the lack of large clinical trials. A registry where all the data can be organized and analyzed therefore becomes... more
Abstract INTRODUCTION AND AIMS: There is currently no consensus about the indications for therapeutic apheresis, also due to the lack of large clinical trials. A registry where all the data can be organized and analyzed therefore becomes a priority for all professionals ...
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Journal of Nephrology is publishing in this issue the results of a randomized clinical study comparing citrate and acetate as pH stabilizer in high-volume online haemodiafiltration (HDF) on interleukin-6 (IL-6) and Klotho levels [1].... more
Journal of Nephrology is publishing in this issue the results of a randomized clinical study comparing citrate and acetate as pH stabilizer in high-volume online haemodiafiltration (HDF) on interleukin-6 (IL-6) and Klotho levels [1]. Acetate has been used in the haemodialysis (HD) dialysate since the 1960s, initially as the sole buffer at high concentrations (30–40 mMol/L). High concentrations, up to 40 mMol/L, result in bicarbonate generation after liver metabolization. At such concentrations acetate is a potent vasodilator and myocardial depressor and can cause intradialytic hypotension [2]. Acetate-based dialysate has been soon associated with other significant side effects, such as nausea and increased inflammatory response [1]. Consequently, in the 1980s bicarbonate-based dialysate progressively replaced acetate-based dialysate, even if the former still contains relatively low amounts of acetate (3–5 mMol/L) to stabilize the pH and prevent calcium precipitation. These levels are still far from physiological, raising concerns especially for the older and more vulnerable dialysis patients with low muscle mass, and therefore at higher risk for acetate intolerance [1]. As pre-dialysis blood levels of acetate are usually lower than 0.1 mMol/L, during treatment the dialysate to blood gradient causes a positive acetate mass balance and a 5–6 fold increase of acetate plasma levels [3]. Acetate mass-transfer has been estimated to be about 72 mMol, that is about 36% of the full buffer gain [3]. By using convective therapies as demonstrated by Fournier et al. [4], acetate mass transfer increases significantly with greater post-dialysis blood acetate levels in patients treated with online HDF compared to bicarbonate HD. Thus, it is conceivable that the residual acetate in the bicarbonate-based dialysate may cause significant side effects to the patient.
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Online haemodiafiltration (HDF) is not a generic term that covers all convection-based renal replacement modalities – an optimal convection dose must be delivered to improve outcomes of end-stage kidney disease patients. In this brief... more
Online haemodiafiltration (HDF) is not a generic term that covers all convection-based renal replacement modalities – an optimal convection dose must be delivered to improve outcomes of end-stage kidney disease patients. In this brief article, we review current facts on HDF technical features, clinical/ biological effects, and financial issues. In summary, HDF today offers highly efficient solute removal over the to-date widest known uraemic toxin molecular weight spectrum. Both safety and efficacy have been demonstrated in several shortand medium-term clinical studies. Recent randomized controled clinical trials and systematic reviews accredited the superiority of online HDF over standard haemodialysis (HD) when adequate convection dose is delivered. Additional clinical trials are needed to establish the optimal convection dose for different clinical settings (e.g. different patient characteristics and/or ethnicities, different substitution fluid delivery modalities) and to establi...
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In patients with advanced kidney disease, metabolic and nutritional derangements induced by uremia interact and reinforce each other in a deleterious vicious circle. Literature addressing the effect of dialysis initiation on changes in... more
In patients with advanced kidney disease, metabolic and nutritional derangements induced by uremia interact and reinforce each other in a deleterious vicious circle. Literature addressing the effect of dialysis initiation on changes in body composition (BC) is limited and contradictory. The aim of this study was to evaluate changes in BC in a large international cohort of incident hemodialysis patients. A total of 8,227 incident adult end-stage renal disease patients with BC evaluation within the initial first 6 months of baseline, defined as 6 months after renal replacement therapy initiation, were considered. BC, including fat tissue index (FTI) and lean tissue index (LTI), were evaluated by Body Composition Monitor (BCM, Fresenius Medical Care, Bad Homburg, Germany). Exclusion criteria at baseline were lack of a BCM measurement before or after baseline, body mass index (BMI) < 18.5 kg/m(2), presence of metastatic solid tumors, treatment with a catheter, and prescription of les...
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Background The aim was to investigate factors associated with the successful achievement of ≥21 l/session of substitution fluid volume in patients on post-dilution hemodiafiltration. Methods 3315 patients treated in 6 European countries... more
Background The aim was to investigate factors associated with the successful achievement of ≥21 l/session of substitution fluid volume in patients on post-dilution hemodiafiltration. Methods 3315 patients treated in 6 European countries with the Fresenius 5008 CorDiax machine including the AutoSub Plus feature were considered. Variables that showed a relationship with convection volume were entered in a multivariable logistic regression model. Results Mean blood flow was 379 ± 68 ml/min. Median substitution volume was 24.7 L (IQR 22.0–27.4 L). Mean filtration fraction was 28.3 ± 4.1%. 81.5% of sessions qualified as high-volume HDF (substitution volumes ≥21 L). Higher age, dialyzer surface area, blood flow and treatment time were positively associated with the achievement of ≥21 L substitution volume; higher body mass index, male gender, higher hematocrit, graft or catheter vs. fistula, and start of week vs. mid-week were negatively associated. Conclusions Dialysis center policy in t...
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This paper describes the historical journey that led to the adoption of on-line hemodiafiltration (HDF) as a standard therapy for the patients in the Fresenius Medical Care (FME) NephroCare dialysis network. In 1998, FME faced the... more
This paper describes the historical journey that led to the adoption of on-line hemodiafiltration (HDF) as a standard therapy for the patients in the Fresenius Medical Care (FME) NephroCare dialysis network. In 1998, FME faced the tremendous challenge of consolidating a series of heterogeneous clinics under one umbrella. In 2002, the European Best Practice Guidelines (EBPG) for hemodialysis (HD) were published by the European Renal Association which FME promptly adopted within its clinic network. On the basis of this document, the strategic decision was taken to apply high-flux, biocompatible membranes throughout the entire network. To cope with the effective implementation of this step, the clinics&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; technical infrastructure was updated. The widespread application of high-flux therapy, together with the implementation of the required infrastructure, especially concerning water quality, opened the way to the extensive use of on-line HDF. To fully realize this ambitious goal, two further technological steps were targeted and successfully reached: introduction of the Fresenius 5008 dialysis equipment and an even stricter control of the water quality. The combined pressure from the educational activities, which brought about a preliminary cultural change, and the creation of a target based on the percentage of treatments by this technique resulted in an increasing implementation of this modality by the individual clinics. After 2004, on-line HDF continuously increased its share among the dialysis techniques prescribed in the network and currently more than 50% of patients are on this modality.
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Hemodiafiltration (HDF) with 20-22 L of substitution fluid is increasingly recognized as associated with significant benefits regarding patient outcome. However, some doubt exists as to whether these high volumes can be achieved in... more
Hemodiafiltration (HDF) with 20-22 L of substitution fluid is increasingly recognized as associated with significant benefits regarding patient outcome. However, some doubt exists as to whether these high volumes can be achieved in routine clinical practice. A total of 4176 sessions with 366 patients on postdilution HDF were analyzed in this 1-month observational cohort study with prospective data collection. All dialysis machines were equipped with AutoSub plus signal analysis software that automatically and continuously adapts the substitution fluid flow according to the blood flow, blood viscosity, and dialyzer characteristics. Percentages of sessions with different types of vascular access were compared regarding achievement of ≥21 L substitution fluid. Logistic regression analysis was conducted to study the independent relationship of selected variables with achievement of ≥21 L substitution volume. Patient- and dialysis-related variables that showed an association with the con...
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Introduction: Dialysis is probably one of the areas of medicine with more guidelines than any other. Issues such as dialysis dose are dealt with in those guidelines, and minimum values to be reached are defined. A target has to be set and... more
Introduction: Dialysis is probably one of the areas of medicine with more guidelines than any other. Issues such as dialysis dose are dealt with in those guidelines, and minimum values to be reached are defined. A target has to be set and reached by using a data-driven continuous quality improvement (CQI) approach. Data collection must be programmed and structured from the beginning. Methods: Fresenius started its activities as a dialysis provider in 1996, following the merger of its dialysis business with the leading service provider in the US, National Medical Care. Currently Fresenius Medical Care’s European activities involve more than 320 dialysis centers located in 15 countries and treating more than 24,000 patients. Management is based on a bi-dimensional organization where line managers can rely on international functional departments. Under this framework, the CQI techniques are applied in conjunction with benchmarking in a system driven by quality targets. In order to comb...
Research Interests: Dialysis, Balanced Scorecard, Continuous Improvement, Benchmarking, Medicine, and 15 moreHumans, Europe, Health Services, Blood, Clinical Governance, Data Collection, Medical Care, Clinical Sciences, Clinical Data, Continuous Quality Improvement, Intensive Care Medicine, Service Provider, Monitoring System, Chronic Kidney Failure, and Renal Dialysis
Due to the challenge of operating within an economically strained healthcare budget, Portuguese health authorities convened with dialysis providers and agreed on a framework to change from a fee-for-service reimbursement modality to a... more
Due to the challenge of operating within an economically strained healthcare budget, Portuguese health authorities convened with dialysis providers and agreed on a framework to change from a fee-for-service reimbursement modality to a capitation payment system for hemodialysis. This article reviews the components of the agreed capitation package implemented in 2008 as well as the necessary preparatory work undertaken by a for-profit 34-unit dialysis network (approx. 4,200 patients) to cope with the introduction of this system. Furthermore, trends in clinical quality indicators and in resource management are reviewed for 3 years immediately following capitation introduction. Here, improvements were observed over time for the specified clinical targets. Simultaneously, costs controllable by the physician could be reduced. As more countries convert to a capitation or bundled payment system for hemodialysis services, this article offers insight into the scope of the necessary preparator...
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National healthcare systems worldwide face growing challenges to reconcile interests of patients for high-quality medical care and of payers for sustainable and affordable funding. Advances in the provision of renal replacement therapy... more
National healthcare systems worldwide face growing challenges to reconcile interests of patients for high-quality medical care and of payers for sustainable and affordable funding. Advances in the provision of renal replacement therapy can only be made by developing and implementing appropriate sophisticated and state-of-the-art business models that include reimbursement schemes for comprehensive care packages. Such business models must succeed in integrating and reconciling the interests of all stakeholders. NephroCare as dialysis provider has adopted and tailored recognized management techniques, i.e. Balanced Scorecard and Kaizen, to achieve these goals. Success of the complete business model package is tangible – strategies initiated to improve treatment quality even at the cost of providers have been translated into win-win scenarios for the complete stakeholder community. Room for improvement exists: the possibility to extend the portfolio of service offerings within the compr...
Research Interests: Business, Stakeholders, Quality of Mental Health Care, Balanced Scorecard, Medicine, and 12 moreQuality of Care, Humans, End Stage Renal Disease, Process management, Business Model, Medical Care, Clinical Sciences, Reimbursement, Healthcare system, Renal Replacement Therapy, Renal Dialysis, and Quality of health care
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Our objective was to analyze the survival of diabetic patients on renal replacement therapy and to compare their survival on extracorporeal and on peritoneal dialysis. All data regarding diabetic patients admitted to dialysis between 1... more
Our objective was to analyze the survival of diabetic patients on renal replacement therapy and to compare their survival on extracorporeal and on peritoneal dialysis. All data regarding diabetic patients admitted to dialysis between 1 January 1983 and 31 December 1993 were collected by means of individual patient questionnaires sent to all of the 44 regional Renal Units (100% answers) of Lombardy, Italy. Cox proportional hazards model, stepwise procedure, was applied in order to select the covariates significantly associated with survival. Age (at baseline), sex, type of diabetes, initial modality of treatment (hemodialysis or peritoneal dialysis), and initial clinical risk factors (malignancies, serious heart disease, vascular disease, cirrhosis of the liver, cachexia) were considered. Descriptive analysis of survival was performed using the Kaplan-Meier technique. The survival of all diabetic patients (895) was 86.5% at one year, 52% at three years, an d 34% at five years. The ma...
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Summary Objectives: The European Clinical Database EuCliD® * has been developed as a tool for supervising selected quality indicators of about 200 European dialysis centers. Major efforts had to be made to comply with local and European... more
Summary Objectives: The European Clinical Database EuCliD® * has been developed as a tool for supervising selected quality indicators of about 200 European dialysis centers. Major efforts had to be made to comply with local and European laws regarding data security. Method: EuCliD® is a Lotus Notes® based flat-file database currently containing medical data of more than 14,000 dialysis patients from 10 European countries. Another 15,000 patients from 150 centers in 4 South-American countries will be added soon. Data are entered either manually or by means of interfaces to existing local data managing systems. This information is transferred to a central Lotus Notes Server. Data evaluation was performed with statistical tools like SPSS. Results: EuCliD® is used as a part of the CQI (Continuous Quality Improvement) management system of Fresenius Medical Care (FMC) dialysis units. Each participating dialysis center receives (currently every half year) benchmarking reports at a regular ...
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To date, single-needle (SN) hemodialysis (HD) requires a dialysis machine equipped with two blood pumps-one controlling arterial blood flow (Qb) and one controlling venous Qb. B. Braun has developed an innovative single-pump SN HD system.... more
To date, single-needle (SN) hemodialysis (HD) requires a dialysis machine equipped with two blood pumps-one controlling arterial blood flow (Qb) and one controlling venous Qb. B. Braun has developed an innovative single-pump SN HD system. Therefore, usability is improved by reducing complexity. The aim of this study was to compare dialysis parameters of the new single-pump SN HD system with a double-pump SN HD system available on the market (Fresenius Medical Care [FMC] 5008). In this two-armed crossover study, patients were randomized into two groups (B. Braun - FMC/FMC - B. Braun). Study period was 2 weeks (6 HD sessions) for each SN HD system. Both B. Braun and FMC dialysis machines were operated in the single-needle auto mode. With the FMC dialysis machines, Qb was optimized manually, whereas for B. Braun machines it was optimized automatically using the auto-mode functionality. A phase volume of 25 mL, treatment time, needle type and size, and dialyzer type and size were kept c...
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In hemodialysis patients extracellular fluid overload is a predictor of all-cause and cardiovascular mortality, and a relation with inflammation has been reported in previous studies. The magnitude and nature of this interaction and the... more
In hemodialysis patients extracellular fluid overload is a predictor of all-cause and cardiovascular mortality, and a relation with inflammation has been reported in previous studies. The magnitude and nature of this interaction and the effects of moderate fluid overload and extracellular fluid depletion on survival are still unclear. We present the results of an international cohort study in 8883 hemodialysis patients from the European MONDO initiative database where, during a three-month baseline period, fluid status was assessed using bioimpedance and inflammation by C-reactive protein. All-cause mortality was recorded during 12 months of follow up. In a second analysis a three-month baseline period was added to the first baseline period, and changes in fluid and inflammation status were related to all-cause mortality during six-month follow up. Both pre-dialysis estimated fluid overload and fluid depletion were associated with an increased mortality, already apparent at moderate...
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Background/aim Vascular access (VA) cannulation is an essential skill for dialysis nurses: failure to correctly repeat this operation daily may result in serious complications for the patients. This study investigates if different aspects... more
Background/aim Vascular access (VA) cannulation is an essential skill for dialysis nurses: failure to correctly repeat this operation daily may result in serious complications for the patients. This study investigates if different aspects of arteriovenous fistula and graft cannulation have an effect on the development of acute access complications, which may affect the VA survival. Methods In April 2009 a cross-sectional survey was conducted in 171 dialysis units located in Europe, the Middle East and Africa to collect details on VA cannulation practices. Information on cannulation retrieved from the survey comprised fistula type and location, cannulation technique, needle size, use of disinfectants and of local anaesthetics, application of arm compression at the time of cannulation, needle and bevel direction, needle rotation, and needle fixation. Five categories of complications were investigated: multiple-cannulation, infiltration, haematoma, haemorrhage and unknown. Results Ther...
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Achieving an adequate dialysis dose is one of the key goals for dialysis treatments. Here we assessed whether patients receiving the current cleared plasma volume (Kt), individualized for body surface area per recommendations, had... more
Achieving an adequate dialysis dose is one of the key goals for dialysis treatments. Here we assessed whether patients receiving the current cleared plasma volume (Kt), individualized for body surface area per recommendations, had improved survival and reduced hospitalizations at 2 years of follow-up. Additionally, we assessed whether patients receiving a greater dose gained more benefit. This prospective, observational, multicenter study included 6129 patients in 65 Fresenius Medical Care Spanish facilities. Patients were classified monthly into 1 of 10 risk groups based on the difference between achieved and target Kt. Patient groups with a more negative relationship were significantly older with a higher percentage of diabetes mellitus and catheter access. Treatment dialysis time, effective blood flow, and percentage of on-line hemodiafiltration were significantly higher in groups with a higher dose. The mortality risk profile showed a progressive increase when achieved minus target Kt became more negative but was significantly lower in the group with 1 to 3 L clearance above target Kt and in groups with greater increases above target Kt. Additionally, hospitalization risk appeared significantly reduced in groups receiving 9 L or more above the minimum target. Thus, prescribing an additional 3 L or more above the minimum Kt dose could potentially reduce mortality risk, and 9 L or more reduce hospitalization risk. As such, future prospective studies are required to confirm these dose effect findings.
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Clinical studies suggest that hemodiafiltration (HDF) may lead to better clinical outcomes than high-flux hemodialysis (HF-HD), but concerns have been raised about the cost-effectiveness of HDF versus HF-HD. Aim of this study was to... more
Clinical studies suggest that hemodiafiltration (HDF) may lead to better clinical outcomes than high-flux hemodialysis (HF-HD), but concerns have been raised about the cost-effectiveness of HDF versus HF-HD. Aim of this study was to investigate whether clinical benefits, in terms of longer survival and better health-related quality of life, are worth the possibly higher costs of HDF compared to HF-HD. The analysis comprised a simulation based on the combined results of previous published studies, with the following steps: 1) estimation of the survival function of HF-HD patients from a clinical trial and of HDF patients using the risk reduction estimated in a meta-analysis; 2) simulation of the survival of the same sample of patients as if allocated to HF-HD or HDF using three-state Markov models; and 3) application of state-specific health-related quality of life coefficients and differential costs derived from the literature. Several Monte Carlo simulations were performed, includin...
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The aim of this study was to verify the importance of continuously monitoring the level of adherence to the anemia guideline recommendations in order to improve not only quality of care but also patient safety. Data presented in this... more
The aim of this study was to verify the importance of continuously monitoring the level of adherence to the anemia guideline recommendations in order to improve not only quality of care but also patient safety. Data presented in this investigation were gained through the FME database EuCliD which contains the clinical data of over 24,000 prevalent patients under treatment at the time of the analysis in 344 dialysis centres in 15 countries. Patient data from 4 countries (United Kingdom, Turkey, Italy, Portugal) was used for this study. The parameter selected was anemia control. The level of hemoglobin (Hb) was considered as the quality indicator for anemia, the target being an Hb level &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;11 g/dL, for UK centres the target was &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;10 g/dL. All new patients commencing hemodialysis between October 2003 and September 30, 2004 with the previous follow-up of less than one month and without previous blood transfusion were considered. A total of 902 patients were enrolled. The study showed that 4 to 6% of the Italian, Portuguese and British patients treated in FME clinics received a blood transfusion during the first year of follow-up. This is consistent with reports by USRDS that only 3.3% of ESRD patients received at least 1 transfusion per quarter in 1992 after erythropoietin became available and was prescribed to 88% of patients. About 18% Turkish patients, required blood transfusions during the first year of follow-up on hemodialysis, which is more comparable with USRDS data reported in 1989, when 16% of patients needed at least 1 transfusion quarterly. In conclusion, the practice of blood transfusion for hemodialysis patients is still frequent especially in elderly patients.
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Hyporesponsiveness to erythropoiesis-stimulating agent therapy in dialysis patients is poorly understood. Some studies report an improvement in the erythropoiesis-stimulating agent resistance index (ERI) with hemodiafiltration (HDF)... more
Hyporesponsiveness to erythropoiesis-stimulating agent therapy in dialysis patients is poorly understood. Some studies report an improvement in the erythropoiesis-stimulating agent resistance index (ERI) with hemodiafiltration (HDF) versus high-flux hemodialysis (HD). We explored ERI dynamics in 38,340 incident HDF and HD patients treated in 22 countries over a 7-year period. Groups were matched by propensity score at baseline (6 months after dialysis initiation). The follow-up period (mean of 1.31 years) was stratified into 1 month intervals with delta analyses performed for key ERI-related parameters. Dialysis modality, time interval, and polycystic kidney disease were included in a linear mixed model with the outcome ERI. Baseline ERI was nonsignificantly higher in HDF versus HD treatment. ERI decreased significantly faster in HDF-treated patients than in HD-treated patients, was decreased in both HD and HDF when patients were treated with intravenous darbepoetin alfa, but only i...
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A simple clinical tool to predict cardiovascular disease risk does not exist for haemodialysis patients. The long-term coronary risk Framingham Heart Study Risk score (FRS), although used in this population, may be inadequate. Therefore,... more
A simple clinical tool to predict cardiovascular disease risk does not exist for haemodialysis patients. The long-term coronary risk Framingham Heart Study Risk score (FRS), although used in this population, may be inadequate. Therefore, we developed separate risk-scores for cardiovascular mortality (CVM) and cardiovascular morbidity & mortality (CVMM) in a Fresenius Medical Care-based haemodialysis patient cohort (AROii). Applying a modified FRS approach, we derived and internally validated two-year risk-scores in incident European adult patients randomly assigned to a development (N=4831) or a validation (N=4796) dataset. External validation was conducted in the third Dialysis Outcomes and Practice Patterns Study (DOPPS III) cohort. Additional discrimination comparing to the FRS was performed. The overall two-year CVM and CVMM event rates were 5.0 and 22.6 per 100 person-years respectively. Common risk predictors included increasing age, cardiovascular disease history, primary dia...