The Initiating Dialysis Early and Late (IDEAL) study: study rationale and design.
OBJECTIVE
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.


METHODS
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.


METHODS
Dialysis units throughout Australia and New Zealand.


METHODS
Patients with ESRD commencing chronic dialysis therapy.


METHODS
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.
Cooper
Bruce A
BA
Department of Renal Medicine, Kolling Institute of Medical Research, Royal North Shore Hospital, University of Sydney, New South Wales, Australia. bcooper@med.usyd.edu.au
Branley
Pauline
P
Bulfone
Liliana
L
Collins
John F
JF
Craig
Jonathan C
JC
Dempster
Jenny
J
Fraenkel
Margaret B
MB
Harris
Anthony
A
Harris
David C
DC
Johnson
David W
DW
Kesselhut
Joan
J
Luxton
Grant
G
Pilmore
Andrew
A
Pollock
Carol A
CA
Tiller
David J
DJ
D017048:Health Care Costs; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications / Q000401:mortality / Q000628:therapy*; D007902:Length of Stay; D015337:Multicenter Studies as Topic; D009752:Nutritional Status; D011446:Prospective Studies; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D006435:Renal Dialysis / Q000009:adverse effects / Q000379:methods*; D012107:Research Design; D013997:Time Factors