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

Bruce A. Cooper, Pauline Branley, Liliana Bulfone, John F. Collins, Jonathan C. Craig, Jenny Dempster, Margaret B. Fraenkel, Anthony Harris, David C.H. Harris, David W. Johnson, Joan Kesselhut, Grant Luxton, Andrew Pilmore, Carol A. Pollock, David John Tiller

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Abstract

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.
Original languageEnglish
Pages (from-to)176-181
Number of pages6
JournalPERITONEAL DIALYSIS INTERNATIONAL
Volume24
Issue number2
Publication statusPublished - Mar 2004
Externally publishedYes

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    Cooper, B. A., Branley, P., Bulfone, L., Collins, J. F., Craig, J. C., Dempster, J., Fraenkel, M. B., Harris, A., Harris, D. C. H., Johnson, D. W., Kesselhut, J., Luxton, G., Pilmore, A., Pollock, C. A., & Tiller, D. J. (2004). The intiating dialysis early and late (ideal) study: Study rationale and design. PERITONEAL DIALYSIS INTERNATIONAL, 24(2), 176-181.