The Double-Icodextrin Dose Randomized Controlled Trial of a Double Icodextrin Dose for Older Patients on Incremental Continuous Ambulatory Peritoneal Dialysis
Abstract
Introduction Icodextrin enhances ultrafiltration (UF) in patients on peritoneal dialysis (PD) but is restricted to 1 bag/d, according to regulatory authorities. The Double-Icodextrin Dose (DIDo) study is a prospective randomized trial investigating the superiority and safety of using 2 bags/d versus 1 bag/d of icodextrin to extend incremental (3 bags/d) continuous ambulatory PD (CAPD) duration in older incident patients. Methods After a 2-month “run-in” period, the patients were randomized to 2 icodextrin (“double dose”) + 1 glucose or 1 icodextrin (“single dose”) + 2 glucose dialysates daily. The primary end point was a composite of excessive use of hypertonic dialysates, transfer to another dialysis modality (automated PD [APD], nonincremental CAPD, or hemodialysis) or death at month 9. Secondary end points included mortality, daily UF, technique survival, rates of peritonitis and hospitalizations, and safety at month 18. Results Forty-one patients were randomized to double dose and 42 to single-dose icodextrin. Baseline characteristics were well-balanced between groups. At month 9, the proportion of patients who discontinued 3 exchanges/d was similar between those receiving the double and the single icodextrin dose (16 [39%] vs. 21 [50%]; HR: 0.69; 95% confidence interval: 0.35–1.33). The results were similar at month 18. Patients in the double dose icodextrin had higher net UF and less hypertonic dialysates use. Rates of peritonitis, hospitalizations, residual urine…
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