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

Cooper, Bruce A., Branley, Pauline, Bulfone, Liliana, Collins, John F., Craig, Jonathan C., Dempster, Jenny, Fraenkel, Margaret B., Harris, Anthony, Harris, David C., Johnson, David W., Kesselhut, Joan, Luxton, Grant, Pilmore, Andrew, Pollock, Carol A. and Tiller, David J. (2004) The Initiating Dialysis Early and Late (IDEAL) study: study rationale and design. Peritoneal Dialysis International, 24 2: 176-181.


Author Cooper, Bruce A.
Branley, Pauline
Bulfone, Liliana
Collins, John F.
Craig, Jonathan C.
Dempster, Jenny
Fraenkel, Margaret B.
Harris, Anthony
Harris, David C.
Johnson, David W.
Kesselhut, Joan
Luxton, Grant
Pilmore, Andrew
Pollock, Carol A.
Tiller, David J.
Title The Initiating Dialysis Early and Late (IDEAL) study: study rationale and design
Journal name Peritoneal Dialysis International   Check publisher's open access policy
ISSN 1718-4304
0896-8608
Publication date 2004-01-01
Sub-type Article (original research)
Open Access Status Not yet assessed
Volume 24
Issue 2
Start page 176
End page 181
Total pages 6
Place of publication Toronto, Ontario, Canada
Publisher Multimed
Language eng
Subject 110312 Nephrology and Urology
Formatted 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.
Keyword End-stage renal disease
ESRD
initiation
survival
economic analysis
cardiac morbidity
nutrition
Q-Index Code C1

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
School of Medicine Publications
 
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