Association Between the Publication of the Initiating Dialysis Early and Late Trial and the Timing of Dialysis Initiation in Canada

Abstract

Initiating Dialysis Early and Late (IDEAL) randomized clinical trial, which randomized patients with an estimated glomerular filtration rate (GFR) between 10 and 15 mL/min/1.73 m 2 to planned initiation of dialysis with an estimated GFR between 10 and 14 mL/min/1.73 m 2 (early start) or an estimated GFR between 5 and 7 mL/min/1.73 m 2 (late start), concluded that early initiation was not associated with improved survival or clinical outcomes. OBJECTIVE To assess the association between the IDEAL trial results and the proportion of early dialysis starts over time. DESIGN, SETTING, AND PARTICIPANTS This interrupted time series analysis used data from the Canadian Organ Replacement Register to study adult (Ն18 years of age) patients with incident chronic dialysis between January 1, 2006, and December 31, 2015, in Canada, which has a universal health care system. Patients from the province of Quebec were excluded because its privacy laws preclude submission of deidentified data without first-person consent. The patients included in the study (n = 28 468) had at least 90 days of nephrologist care before starting dialysis and a recorded estimated GFR at dialysis initiation. Data analyses were performed from November 2016 to January 2019. MAIN OUTCOMES AND MEASURES The primary outcome was the proportion of early dialysis starts (estimated GFR >10.5 mL/min/1.73 m 2), and the secondary outcomes included the proportions of acute inpatient dialysis starts, patients who started dialysis using a home modality, and patients receiving hemodialysis who started with an arteriovenous access. Measures included the trend prior to the IDEAL trial publication, the change in this trend after publication, and the immediate consequence of publication. RESULTS The final cohort comprised 28 468 patients, of whom 17 342 (60.9%) were male and the mean (SD) age was 64.8 (14.6) years. Before the IDEAL trial, a statistically significant increasing trend was observed in the monthly proportion of early dialysis starts (adjusted rate ratio, 1.002; 95% CI, 1.001-1.004; P = .004). After the IDEAL trial, an immediate decrease was observed in the proportion of early dialysis starts (rate ratio, 0.874; 95% CI, 0.818-0.933; P < .001), along with a statistically significant change in trend between the pretrial and posttrial periods (rate ratio, 0.994; 95% CI, 0.992-0.996; P < .001). No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication. CONCLUSIONS AND RELEVANCE The publication of the IDEAL trial appeared to be associated with an immediate and meaningful change in the timing of dialysis initiation in Canada.

Early initiation of PD therapy in elderly patients is associated with increased risk of death

“…In the USA, the proportion of incident ESRD patients starting dialysis therapy at an eGFR ≥10 mL/min/1.73 m 2 rose from 12.9% in 1996 to 42.6% in 2010, but decreased to 38.4% in 2017 [ 2 ]. A similar trend was found in Canada, where the percentage of patients starting early dialysis therapy (eGFR ≥10.5 mL/min/1.73 m 2 ) rose from 29% in 2001 to 44% in 2009 [ 9 ], while decreasing to 34% in the 2011–15 period [ 10 ]. In recent years, some observational studies have indicated that early commencement of dialysis offers no survival benefit or may be harmful [ 11–16 ].…”

Intradialytic Nutrition and Hemodialysis Prescriptions: A Personalized Stepwise Approach

“…The idea that, in dialysis, "more is better" is not true for fragile patients. The failure of early dialysis start, which was previously considered synonymous with "healthy" dialysis start, to improve patients' prognoses, the recognition of the importance of residual kidney function in determining survival, and the association of the latter with better nutritional status are all elements in favor of a progressive, incremental dialysis start aimed at reducing dialysis-related morbidity and mitigating "dialysis shock" [21][22][23][94][95][96][97][98][99].…”

Novel trial strategies to enhance the relevance, efficiency, effectiveness, and impact of nephrology research

“…This study clearly demonstrated that IDEAL findings were implemented promptly and underscored the usefulness of registry data in assessing implementation success and impact. 35…”