Effect of increased convective clearance by on-line hemodiafiltration on all cause and cardiovascular mortality in chronic hemodialysis patients - the Dutch CONvective TRAnsport STudy (CONTRAST): rationale and design of a randomised controlled trial [ISRCTN38365125]

E Lars Penne, Peter J Blankestijn, Michiel L Bots, Marinus A van den Dorpel, Muriel P Grooteman, Menso J Nubé, Ingeborg van der Tweel, Piet M Ter Wee, the CONTRAST study group, E Lars Penne, Peter J Blankestijn, Michiel L Bots, Marinus A van den Dorpel, Muriel P Grooteman, Menso J Nubé, Ingeborg van der Tweel, Piet M Ter Wee, the CONTRAST study group

Abstract

BACKGROUND: The high incidence of cardiovascular disease in patients with end stage renal disease (ESRD) is related to the accumulation of uremic toxins in the middle and large-middle molecular weight range. As online hemodiafiltration (HDF) removes these molecules more effectively than standard hemodialysis (HD), it has been suggested that online HDF improves survival and cardiovascular outcome. Thus far, no conclusive data of HDF on target organ damage and cardiovascular morbidity and mortality are available. Therefore, the CONvective TRAnsport STudy (CONTRAST) has been initiated. METHODS: CONTRAST is a Dutch multi-center randomised controlled trial. In this trial, approximately 800 chronic hemodialysis patients will be randomised between online HDF and low-flux HD, and followed for three years. The primary endpoint is all cause mortality. The main secondary outcome variables are fatal and non-fatal cardiovascular events. CONCLUSION: The study is designed to provide conclusive evidence whether online HDF leads to a lower mortality and less cardiovascular events as compared to standard HD.

Figures

Figure 1
Figure 1
Hypothesis
Figure 2
Figure 2
Sequential analysis. Boundaries for a double sequential triangular test with α = 0.05, power 0.80 and hazard ratio 0.75. Z is the observed number of events in the control group minus the expected number of events given treatment equivalence. V is approximately equal to a quarter of the number of events observed.

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