Deakin University

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The initiating dialysis early and late (ideal) study: Study rationale and design

journal contribution
posted on 2004-03-01, 00:00 authored by B A Cooper, P Branley, Liliana Bulfone, J F Collins, J C Craig, J Dempster, M B Fraenkel, A Harris, D C Harris, D W Johnson, J Kesselhut, G Luxton, A Pilmore, C A Pollock, D J Tiller
◆ Objectives: The primary objective of the IDEAL study is to determine whether the timing of dialysis initiation has an effect on survival in subjects with end-stage renal disease (ESRD). The secondary objectives are to determine the impact of "early start" versus "late start" dialysis on nutritional and cardiac morbidity, quality of life, and economic cost. ◆ Design: Prospective multicenter randomized controlled trial. Patients are randomized to commence dialysis at a glomerular filtration rate (by Cockcroft-Gault) of either 10 - 14 mL/minute/1.73 m2 ("early start") or 5 - 7 mL/min/1.73 m2 ("late start"), with stratification for dialysis modality (hemodialysis vs peritoneal dialysis), study center, and the presence or not of diabetes mellitus. ◆ Setting: Dialysis units throughout Australia and New Zealand. ◆ Patients: Patients with ESRD commencing chronic dialysis therapy. ◆ Outcome Measures: Three years from randomization, all-cause mortality, morbidity, and economic impact; structural and functional cardiac status, nutritional state, and quality of life will be assessed. ◆ Results: To date, 388 patients of a minimum 800 patients have been entered and randomized into the study. Current recruitment rates suggest sufficient patients will be enrolled by December 2004 and follow-up completed by December 2007. ◆ Conclusions: The IDEAL study will provide evidence for the optimal time to commence dialysis. Copyright © 2004 International Society for Peritoneal Dialysis.



Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis






176 - 181




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Publication classification

C1.1 Refereed article in a scholarly journal