"Initiating Dialysis Early and Late (IDEAL) Study". The New England Journal of Medicine. 2010. 363(7):609-619. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
Does early initiation of maintenance dialysis in patients with stage V chronic kidney disease improve survival and clinical outcomes compared with a late start?
In patients with stage V chronic kidney disease, planned early initiation of dialysis did not result in better survival or clinical outcomes compared with delayed initiation. These findings suggest that dialysis can be postponed until traditional clinical indicators for its initiation are present.
The IDEAL study examined whether early initiation of maintenance dialysis when estimated GFR was between 10.0-14.0 ml/min (early start) versus initiation when estimated GFR was between 5.0-7.0 ml/min (late start) influenced patient survival in adults with progressive chronic kidney disease. No significant difference in survival or the incidence of adverse events was observed.
National and international guidelines have historically recommended various GFR levels for the initiation of dialysis in patients with chronic kidney disease. However, prior to the IDEAL study, these recommendations were based on observational studies that were potentially confounded.
- A multicenter, randomized, controlled trial - N=828 adult patients with progressive chronic kidney disease - Early Start: Estimated GFR of 10.0 to 14.0 ml/min (n=404) - Late Start: Estimated GFR of 5.0 to 7.0 ml/min (n=424) - Setting: 32 centers in Australia and New Zealand - Enrollment: July 2000 to November 2008 - Median follow-up: 3.59 years - Analysis: Intention-to-treat
Inclusion Criteria - Age 18 years or older - Progressive chronic kidney disease - Estimated GFR between 10.0 and 15.0 ml/min/1.73 m^2
Exclusion Criteria - Age <18 years - Estimated GFR <10.0 ml/min - Plans for live-donor kidney transplant within 12 months - Recently diagnosed cancer affecting survival - Inability to provide consent
Baseline Characteristics - Mean age: 60.4 years - Gender: 542 men, 286 women - Patients with diabetes: 355
- Random assignment to commence dialysis early or delay until later stages of GFR decline.
Primary Outcome - All-cause mortality - Early Start: 37.6% died - Late Start: 36.6% died - Hazard ratio for early initiation: 1.04 (95% CI, 0.83 to 1.30; P=0.75)
- No significant difference in cardiovascular events, infections, or complications of dialysis.
- The intervention could not be blinded due to its nature. - Mean GFR values at the start of dialysis did not align exactly with target ranges due to clinical recommendations.
The study was funded by the National Health and Medical Research Council of Australia, the Australian Health Ministers Advisory Council, the Royal Australasian College of Physicians/Australian and New Zealand Society of Nephrology, the National Heart Foundation (Australia and New Zealand), and unrestricted grants from Baxter Healthcare, Health Funding Authority New Zealand, the International Society for Peritoneal Dialysis, Amgen Australia, and Janssen–Cilag.
- Additional information and study details can be found in the full text The New England Journal of Medicine article.