Dialysis and Supportive Care in Elderly patients with advanced Renal disease

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The burden of end stage kidney disease is growing globally. Much of this growth since the turn of the century has been in elderly patients, a group in whom the outcomes from both dialysis and non-dialysis treatments are poor. Optimal therapy for these older patients with end stage kidney disease is not clear and practice varies widely. Recent literature shows high mortality rates in older patients receiving dialysis, with an average mortality of 27% in the first year. Data on the outcomes from non-dialysis treatment, usually referred to as supportive care, is much less clear. This is because: • There are no registries of patients receiving supporting care • It is difficult to define a clear start-in point for supportive care, as opposed to dialysis initiation • Dialysis patient groups compared to supportive care patients have large differences in co-morbidities • There is crossover between the two patient pathways The only effective way to better understand the effects of the dialysis and the supportive care treatment approaches is to randomly apply the treatments in a clinical trial. This approach allows the issues of lead-time bias, residual confounding and cross-over to be eliminated or managed, thereby producing findings of the highest clinical and scientific value. It is the view of the investigators of the DISCERN Trial that, where clinicians and patients have equipoise around the relative benefits and risks of dialysis and supportive care, to randomly allocate patients to either of these treatment approaches is an appropriate and ethical approach. In a setting for scarce healthcare resources, understanding this balance arising from a resource-intensive treatment such as dialysis is the appropriate path to guide resource allocation. Objectives: The primary null hypothesis of the DISCERN study is that, in highly co-morbid patients aged over 75 years with stage 5 chronic kidney disease, medical management including maintenance dialysis compared to medical treatment alone is associated with no differences in the outcome of mortality. Secondary null hypotheses will examine the effect of the same comparison upon the outcomes of quality of life, burden of hospitalisation and cost-effectiveness. Study Design: The DISCERN study is a randomised, controlled trial with blinding of outcome assessment. Participants will be randomised on a 1:1 basis to the two study arms: Medical treatment with maintenance dialysis, OR medical treatment (with no maintenance dialysis).

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