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IDEAL

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

Clinical Question

Does early initiation of maintenance dialysis in patients with stage V chronic kidney disease improve survival and clinical outcomes compared with a late start?

Bottom Line

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.

Major Points

Guidelines

Design

- 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

Population

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

Interventions

- Random assignment to commence dialysis early or delay until later stages of GFR decline.

Outcomes

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)

Secondary Outcomes
- No significant difference in cardiovascular events, infections, or complications of dialysis.

Criticisms

- 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.

Funding

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.