Outcomes of patients with planned initiation of hemodialysis in the IDEAL trial

BACKGROUND: In clinical practice there is considerable variation in the timing of initiation of dialysis. The IDEAL trial (Initiating Dialysis Early and Late study) showed that planned early initiation of dialysis in patients with stage 5 chronic kidney disease (CKD) was not associated with an improvement in clinical outcome, but was associated with increased costs. The predominant dialysis modality worldwide is hemodialysis (HD). This subanalysis of the IDEAL trial examined whether the timing of the initiation of dialysis in those who had chosen HD influenced survival and the occurrence of complications. METHODS: Patients on the IDEAL trial were older than 18 years and had progressive advanced CKD. They were randomly assigned to commence dialysis at an estimated glomerular filtration rate (eGFR) of 10-14 ml/min (early start) or when the eGFR was 5-7 ml/min (late start). The primary outcome was death from any cause. RESULTS: Between 2000 and 2008, 362 of the 828 patients (43.7%) randomized in the trial planned to commence HD. 322 (88.9%) of these subsequently commenced HD and 17 (4.7%) commenced peritoneal dialysis, with a median time to the initiation of dialysis of 1.63 months in the early-start group and 6.93 months in the late- start group. During a median follow-up time of 3.81 years, 50 of 171 patients in the early-start group (29.2%) and 59 in the late-start group (30.1%) died (hazard ratio with early initiation=0.97: 95% CI: 0.66-1.41; p=0.86). There was no significant difference in the frequency of cardiovascular events, infections, or access-related events, but there was a significantly higher frequency of fluid and electrolyte events in the late-start group (p=0.02). CONCLUSION: In this subanalysis of the IDEAL trial, patients commencing dialysis early with stage 5 CKD for whom the planned dialysis modality was HD did not have an improvement in survival or any reduction in most clinical outcomes apart from fluid and electrolyte events.