title: The Initiating Dialysis Early and Late (IDEAL) study: study rationale and design.
abstract: 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.
authors.affiliation: 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
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Cooper
authors.forename: Pauline
authors.initials: P
authors.lastname: Branley
authors.forename: Liliana
authors.initials: L
authors.lastname: Bulfone
authors.forename: John F
authors.initials: JF
authors.lastname: Collins
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Craig
authors.forename: Jenny
authors.initials: J
authors.lastname: Dempster
authors.forename: Margaret B
authors.initials: MB
authors.lastname: Fraenkel
authors.forename: Anthony
authors.initials: A
authors.lastname: Harris
authors.forename: David C
authors.initials: DC
authors.lastname: Harris
authors.forename: David W
authors.initials: DW
authors.lastname: Johnson
authors.forename: Joan
authors.initials: J
authors.lastname: Kesselhut
authors.forename: Grant
authors.initials: G
authors.lastname: Luxton
authors.forename: Andrew
authors.initials: A
authors.lastname: Pilmore
authors.forename: Carol A
authors.initials: CA
authors.lastname: Pollock
authors.forename: David J
authors.initials: DJ
authors.lastname: Tiller
mesh_terms: 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