Abstract
BackgroundThe 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.MethodsCONTRAST 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.ConclusionThe study is designed to provide conclusive evidence whether online HDF leads to a lower mortality and less cardiovascular events as compared to standard HD.
Highlights
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
Chronic HD patients suffer from atherosclerotic complications at a relatively younger age and die younger from ischemic heart disease [2]
It is conceivable that dialysis modalities with superior MM removal reduce cardiovascular disease (CVD) and improve survival
Summary
Objectives The primary objective of CONTRAST is to assess the effect of on-line HDF on all cause mortality, when compared to. When randomised for online HDF, patients will be treated with a target post-dilution dose of 6 l/h (~100 ml/min) and a high-flux synthetic dialyser (UF-coefficient > 20 ml/mmHg/h). When used for HDF, sterile non-pyrogenic solution is prepared on-line from the ultra pure dialysis fluid by an additional step of ultrafiltration using a sterile polyamide ultrafilter (U2000) integrated in a sterile line set (Steriset). Interim analysis In this study, group sequential interim analyses will be performed to evaluate the primary outcome variable. The reason for this approach is that, on average, fewer patients are needed in the study when the expected difference in the primary outcome variable is real or when no difference of the hypothesised magnitude can be expected anymore.
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