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NDT Advance Access originally published online on November 28, 2007
Nephrology Dialysis Transplantation 2008 23(2):438-443; doi:10.1093/ndt/gfm791
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© The Author [2007]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org


Haemodiafiltration: promise for the future?

Neelke C. van der Weerd1,2, E. Lars Penne1,2, Marinus A. van den Dorpel3, Muriel P.C. Grooteman2, Menso J. Nube2,4, Michiel L. Bots5, Piet M. ter Wee2 and Peter J. Blankestijn1

1Department of Nephrology, University Medical Center, Utrecht, 2Department of Nephrology, Vrije Universiteit Medical Center, Amsterdam, 3Department of Nephrology, Medical Center Rijnmond Zuid, Rotterdam, 4Department of Nephrology, Medical Center Alkmaar and 5Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands

Correspondence and offprint requests to: Peter J. Blankestijn, University Medical Center, Department of Nephrology, Room F03.226, PO BOX 85500, 3508 GA Utrecht, The Netherlands. Tel: +31-88-7557329; Fax: +31-30-2543492; E-mail: P.J.Blankestijn{at}umcutrecht.nl

Keywords: haemodialysis; on-line haemodiafiltration



   Introduction
Top
 Introduction
Theoretical background
 Technical considerations
 Evaluation of olHDF as...
 Conclusion
 Acknowledgements.
 References
 
During haemodiafiltration (HDF), diffusive and convective transport are combined for the removal of waste solutes. Fluid removal exceeds the desired weight loss, and fluid balance is maintained by infusion of a sterile pyrogen-free solution. This dialysis modality may offer advantages, as compared to haemodialysis (HD) or haemofiltration (HF) used separately.This brief editorial comment summarizes currently available knowledge on technical and (pre-)clinical aspects of HDF, as well as currently ongoing trials.



   Theoretical background
Top
 Introduction
 Theoretical background
Technical considerations
 Evaluation of olHDF as...
 Conclusion
 Acknowledgements.
 References
 
In HDF, not only small molecules (<5 kDa) are removed more effectively as compared to low-flux HD, but in addition, a considerable clearance of so-called middle molecular weight (MMW) substances (5–50 kDa) is obtained [1]. Beta2-microglobulin (ß2M, MW 11.8 kD) is a typical example of this category and is strongly associated with the presence of carpal tunnel syndrome and dialysis-related amyloidosis in chronic HD patients. In the HEMO study (see details below), predialysis ß2M levels were associated with all-cause mortality, even when adjusted for residual renal clearance [2]. These data suggest that ß2M can be used as a marker for MMW toxins which contribute to the extremely high mortality in chronic HD patients, although a direct relationship between ß2M levels and mortality is lacking.

Other examples of MMW molecules include markers of inflammation such as IL-6, TNF-{alpha} and complement factor D and other molecules that might be relevant in the pathogenesis of cardiovascular morbidity and mortality, such as advanced glycation end products (AGEs) and mediators of oxidative stress [3].

HD using high-flux membranes can be considered as a form of HDF, because the pressure drop along the fibres induces filtration that can be considerable (8–10 L per treatment). The total amount of ultrafiltration exceeds the required weight loss and is compensated by backfiltration. However, the exact volume of filtration in high-flux HD is unpredictable, unmeasurable and fluctuates per treatment.

In HDF, the volume of ultrafiltration can be larger (10–30 L per treatment in the postdilution mode) and can be controlled. The substitution volume infused into the patient compensates for the total ultrafiltration volume (i.e. convection volume) minus the desired weight loss. It can be added downstream (postdilution) or upstream (predilution) from the dialyser. In the latter mode, less small molecular clearance is obtained for a given filtration volume, as diffusion is less effective when compared to the postdilution mode. In predilution HDF, the concentration-gradient driven diffusion is reduced because of dilution, as substitution fluid is added ahead of the filter.

High-flux HD and low-efficiency HDF
As mentioned before, high-flux HD can be considered as a form of ‘low-efficiency HDF’, because internal filtration induces convective clearance. Although a considerable amount of convective transport can be obtained by this modality, the HEMO study showed no difference in survival between low- and high-flux HD. However, significant risk reductions in death from cardiac causes and in the combined outcome of first hospitalization for cardiac causes or death from cardiac causes were observed [4]. In this prospective clinical trial, 1800 prevalent HD patients were randomized to either low-flux or high-flux membranes, with a mean follow-up of almost 3 years. One post hoc sub-analysis of this study suggests a survival benefit of high-flux membranes for patients on HD for more than 3.7 years [5]. In addition, another post hoc sub-analysis suggested a decreased risk of death from cerebrovascular disease (CBVD) for patients on high-flux HD, without baseline evidence of CBVD, or with a duration of HD therapy longer than 3.7 years [6].

Very recently, the results of two other randomized clinical trials were presented. First, the European Membrane Permeability and ESRD Patient Outcome (MPO) study, originally designed to study the outcome in hypoalbuminaemic HD patients [7], showed a survival advantage in this group if they were treated with high-flux membranes. However, the study was amended underway due to slow enrolment so that the study protocol was opened to normoalbuminaemic subjects as well. In the overall group (containing hypoalbuminaemic and normoalbuminaemic patients) no survival advantage for high-flux was observed. Diabetic patients showed a survival advantage for high-flux HD, both for the overall and the hypoalbuminaemic group (F. Locatelli, oral presentation EDTA Barcelona 2007). Second, a post hoc analysis of the 4D study, which was originally designed to analyse the effect of atorvastatin in diabetic chronic HD patients on the composite endpoint of cardiovascular mortality and morbidity, showed a superior survival in patients treated with high-flux as compared to low-flux membranes [8].

Thus, until now, high-flux HD has not been shown to reduce mortality in the general HD population, although selected subgroups, such as diabetic or hypoalbuminaemic patients, or patients who are on HD therapy for a long time, may benefit from high-flux HD.

HDF used to be performed with commercially produced substitution fluid in 5 L bags. The applicability of this treatment was limited due to its logistic complexity and high costs. As a consequence, only small convective volumes could be obtained (<15 L per session), the so-called low-efficiency HDF or low-volume HDF. These volumes are in the same range as those obtained with high-flux HD. Furthermore, in the Dialysis Outcomes and Practice Patterns Study (DOPPS) cohort, for patients in the low-efficiency HDF group, the overall mortality was 12.6 deaths per 100 patient years, whereas in the high-flux HD group, the overall mortality was 12.7 deaths per 100 patient years [9]. Therefore, no additional benefit was achieved from low-efficiency HDF as compared to high-flux HD, both in terms of convective clearance and survival.

The development of online systems that prepare substitution fluid continuously has made HDF easier and much less expensive [10–12]. The question whether online HDF (olHDF), in which much more convective volume can be obtained, will result in clinical and survival benefit, will be addressed below.



   Technical considerations
Top
 Introduction
 Theoretical background
 Technical considerations
Evaluation of olHDF as...
 Conclusion
 Acknowledgements.
 References
 
As a substantial amount of online-produced substitution fluid is infused directly into the patient, assurance of its chemical quality and microbiological purity is mandatory. Ultrapure water is mixed with high-quality concentrate components for the production of ultrapure dialysis fluid, from which substitution fluid for olHDF is continuously obtained by an extra step of ultrafiltration. The water distribution system must be maintained in hygienic conditions, by guaranteeing a continuous water flow and periodical thermal or chemical disinfection to prevent the formation of a biofilm. Hence, the production process of substitution fluid includes strict periodic evaluation of its quality. These aspects are discussed elsewhere in more detail [10–12].

Apart from a more complex purification system for water and dialysis fluid, some specific requirements are needed to perform olHDF on a routine basis. High-flux membranes are used and equipment able to deliver olHDF is needed. In order to obtain a high convection volume, the patient needs to have an adequate vascular access for achieving relatively high blood flows. Generally, the total ultrafiltration flow in the postdilution mode can be maximally 25–30% of the blood flow. Thus, in order to obtain a convection volume of, for instance, 6 L/h (24 L during an average session), blood flow needs to be 300 to 400 ml/min.



   Evaluation of olHDF as renal replacement therapy: effects on (pre-)clinical variables and survival
Top
 Introduction
 Theoretical background
 Technical considerations
 Evaluation of olHDF as...
Conclusion
 Acknowledgements.
 References
 
Preclinical variables
Kt/Vurea is a well-established marker of dialysis adequacy and removal of small molecular weight substances. It is used as a variable to compare different dialysis techniques, although the importance of a high Kt/Vurea has been challenged by the HEMO study [13,14].

The removal of larger molecules accumulating in chronic HD patients depends almost exclusively on the permeability characteristics of the dialyser membrane and the convection volume. Therefore, these substances are removed by olHDF, in which high-flux membranes are used, and not by conventional low-flux HD. In predilution olHDF, a higher ultrafiltration rate is needed as compared with postdilution olHDF, to obtain equal MMW clearance because of dilution ahead of the filter in predilution olHDF.

Several observational and randomized studies have shown that predialysis levels of ß2M are reduced when patients are switched to olHDF [Table 1).


View this table:
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  		Table 1. Selection of studies evaluating the effect of HDF on various biochemical and clinical variables and on survival (NB: some studies did not have the mentioned variable as a primary outcome)

 
Phosphate is a small molecule; however, because it is surrounded by water molecules, it has a clearance profile similar to that of MMW substances. Superior clearance of phosphate by HDF has been demonstrated in some studies [17].

Given the importance of clearance of MMW substances, quantified for instance by ß2M clearance, the effects of the various treatment modalities may be compared in that respect and then appear to show substantial differences. Standard low-flux HD and peritoneal dialysis provide (virtually) no clearance of ß2M. Measurable reductions can be obtained by HF and high-flux HD, especially when long treatment times are applied, such as with nocturnal HD [2,24].

Clinical variables
Because olHDF removes substances in a broader range of molecule sizes as compared to conventional low-flux HD, it provides a therapy somewhat better mimicking the human kidney. Therefore, it might provide a real improvement on clinically meaningful variables.

For example, several reports of non-randomized trials have come up with the interesting finding of decreased erythropoietin resistance in patients treated with HDF [14,17].

A number of studies suggests that olHDF is associated with an improvement of haemodynamic stability and blood pressure control [29].

Beneficial effects of HDF on other clinical parameters, e.g. markers of nutritional status, quality of life and prevalence of dialysis-related amyloidosis, have been reported in a number of studies (Table 1). Most of these studies were performed in a non-randomized, observational or cross-over design and/or in small patient groups. Adequately powered randomized trials on the effect of HDF on clinical parameters are currently lacking.

Survival
Several observational studies suggest a benefit of olHDF on survival (Table 1). The use of high-efficiency HDF in the DOPPS cohort (convection volume of >15 L per session, which will mean olHDF in most cases for obvious logistical reasons) was associated with a 35% reduction in mortality risk, even after correction for various confounding factors [9]. In contrast, low-efficiency HDF (convection volume <15 L per session) was not associated with any significant reduction of risk. Another large observational study from Eastern Europe reported 37% mortality risk reduction in patients on olHDF [32]. In a smaller observational study from the USA, olHDF was associated with an almost 60% reduction of risk of mortality [33]. In a systematic review on the effect of HDF (low and high volume) on survival, including data from 336 patients in four randomized controlled trials, a significantly greater mortality risk in patients treated with HDF was found, as compared to HD. However, even the sum of the available trials was not adequately powered to detect superior survival, most trials had suboptimal methodological quality and were difficult to compare because of different study protocols [34–36].

Ongoing trials
Despite the observational data mentioned above, the merits of olHDF have yet to be determined in properly designed and adequately powered randomized controlled trials.

The Dutch Convective Transport Study (CONTRAST) is a prospective randomized trial on the effect of online HDF on all-cause mortality and cardiovascular (CV) morbidity and mortality. 700 patients will be enrolled in more than 23 centres and will be followed until the end of 2010. According to the main hypothesis, better clearance of MMW substances results in a better correction of the uraemic environment, ultimately leading to a reduction in all-cause mortality and CV morbidity and mortality. Patients on standard low-flux HD with an adequate spKt/Vurea are either switched to olHDF or standard HD is continued. For HDF, target substitution volume is 6 L/h in the postdilution mode. Rationale and design of the study are presented elsewhere [37,38].

In a French prospective randomized trial, HDF is compared to high-flux HD in 600 patients older than 65 years, who are followed for 2 years. The primary endpoint is intradialytic morbidity (hypotension and symptoms), whereas secondary endpoints are all-cause and cardiovascular mortality and laboratory markers of lipid metabolism, oxidative stress and inflammation [39].

In an Italian study, almost 250 chronic HD patients will be randomized for either a convective therapy [predilution HDF (25%) or HF (25%)], or low-flux HD (50%), with a follow-up period of 2 years. Haemodynamic stability and blood pressure control are studied as primary outcomes, whereas secondary outcomes are morbidity and overall and cardiovascular mortality [40]. As the follow-up has already ended, the results of this study are soon to be expected.



   Conclusion
Top
 Introduction
 Theoretical background
 Technical considerations
 Evaluation of olHDF as...
 Conclusion
Acknowledgements.
 References
 
Presently, HDF with online production of substitution fluid is possible and can be performed safely on a considerable scale in everyday clinical practice. Some specific technical requirements are needed, including standard use of high-flux membranes. Reverse osmosis and dialysis machines must be able to produce sterile and non-pyrogenic fluids, of which the microbiological and chemical quality are validated and controlled periodically. The patient must have a vascular access able to deliver a sufficient blood flow through the extracorporeal circuit.

OlHDF provides a measurable reduction in various substances suspected to be clinically relevant ‘uraemic’ toxins, which are not cleared by standard low-flux HD. Observational studies suggest a dosage-related substantial improvement in clinical parameters and reduction of mortality. However, observational studies are sensitive to bias. Therefore, properly designed randomized controlled trials need to establish whether olHDF reduces cardiovascular morbidity and all-cause mortality. Only after completing such studies might the question raised in the title be answered.



   Acknowledgements.
Top
 Introduction
 Theoretical background
 Technical considerations
 Evaluation of olHDF as...
 Conclusion
 Acknowledgements.
References
 
N.C. van der Weerd (MD) and E.L. Penne (MD) are supported by a grant of the Dutch Kidney Foundation (no. C02.2019). Unrestricted grants are provided by Fresenius Medical Care, Gambro, Roche and Baxter Extramural Grant Program.

Conflict of interest statement. None declared.



   References
Top
 Introduction
 Theoretical background
 Technical considerations
 Evaluation of olHDF as...
 Conclusion
 Acknowledgements.
 References
 

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Received for publication: 5. 8.07
Accepted in revised form: 10.10.07


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