SUPERIORITY OF ICODEXTRIN TO 2.5% GLUCOSE DIALYSATE FOR LONG-DWELL EXCHANGE IN PEDIATRIC PERITONEAL DIALYSIS (ICO-PPD): A MULTICENTER RANDOMIZED CROSSOVER STUDY

 

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https://storage.unitedwebnetwork.com/files/1099/8d8b4a6dd27a10ff2c30d63dfe460f09.pdf
SUPERIORITY OF ICODEXTRIN TO 2.5% GLUCOSE DIALYSATE FOR LONG-DWELL EXCHANGE IN PEDIATRIC PERITONEAL DIALYSIS (ICO-PPD): A MULTICENTER RANDOMIZED CROSSOVER STUDY

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Riku
Hamada
Riku Hamada hamariku@gmail.com Tokyo Metropolitac Children's Medical Center Nephrology and Rheumatology Tokyo Japan *
Hiroshi Hataya hiroshi_hataya@tmhp.jp Tokyo Metropolitac Children's Medical Center Nephrology and Rheumatology Tokyo Japan -
Natsumi Yamamura yamamur@wch.opho.jp Osaka Women's and Children's Hospital Pediatric Nephrology and Metabolism Izumi Japan -
Naoya Fujita fujita708@hkg.odn.ne.jp Aichi Children’s Health and Medical Center Pediatric Nephrology Obu Japan -
Tomoo Kise kitomoo@yahoo.co.jp Okinawa Prefectural Nanbu Medical Center & Children's Medical Center Pediatric Nephrology Haebaru-cho Japan -
Yusuke Okuda okuda@kitasato-u.ac.jp Kitasato University School of Medicine Pediatrics Sagamihara Japan -
Hirotsugu Kitayama very.hiro@nifty.com Shizuoka Prefectural Children’s Hospital Pediatric Nephrology Shizuoka Japan -
Tsubasa Murase pmx.03.g.o@gmail.com Shinshu University Hospital Pediatrics Matsumoto Japan -
Yoshihiko Morikawa morikaway@white.plala.or.jp Tokyo Metropolitan Hospital Organization Clinical Research Promotion Center Tokyo Japan -
Tetsuji Kaneko tkaneko-tky@umin.ac.jp Tokyo Metropolitan Hospital Organization Clinical Research Promotion Center Tokyo Japan -
Katsusuke Yamamoto katz0212@wch.opho.jp Osaka Women's and Children's Hospital Pediatric Nephrology and Metabolism Izumi Japan -
Motoshi Hattori hattori@twmu.ac.jp Tokyo Women's Medical University Pediatric Nephrology Tokyo Japan -
Masataka Honda mhond@fol.hi-ho.ne.jp Tokyo Metropolitan Children's Medical Center Nephrology and Rheumatology Tokyo Japan - Tokyo Metropolitan Hospital Organization Clinical Research Promotion Center Tokyo Japan
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Peritoneal dialysis (PD) is an important kidney replacement therapy for children with end-stage kidney disease (ESKD). Children require greater ultrafiltration (UF) per body surface area than adults. To maintain a stable fluid balance throughout the day, net UF during the long, daytime dwell is particularly crucial for anuric patients. In adults, icodextrin dialysate (ICO) achieved greater UF than 2.5% glucose dialysate (2.5% GD) during long dwells.

However, its efficacy in pediatric PD remains unclear. This study aimed to determine whether ICO would be able achieve better UF and solute clearance than 2.5% GD during long (12-hour) and intermediate (8-hour) dwell exchanges in children undergoing PD.

The present, multicenter, randomized crossover trial enrolled pediatric PD patients aged < 18 years who had been undergoing PD for at least three months. Patients with peritonitis or abdominal surgery within three months prior to study commencement were excluded. Participants were randomly assigned to two sequences: Group A (ICO→2.5% GD) and Group B (2.5% GD→ICO). Each dialysate was tested for two consecutive days using standard dwell volumes of 800 ± 100 mL/m² for 8-hour and 12-hour exchanges.

The primary outcome was the difference in UF volume per body surface area between ICO and 2.5% GD during the 12-hour dwell. Secondary outcomes included the difference in UF by peritoneal transport category and during the 8-hour dwell and solute removal performance (urea nitrogen, creatinine, potassium, phosphate).

Twenty-four of 25 participants completed the study (males: 13; median age: 4.0 years, median PD duration: 22.0 months, anuric patients: 13). Peritoneal equilibration test (PET) categories were high (H) in eight, high-average (HA) in 12, and low-average (LA) in four, patients.

During the 12-hour dwell, ICO achieved significantly greater UF than 2.5% GD (mean difference: 136.9 mL/m²; 95% CI: 75.6–198.2; p<0.01). The superiority of ICO was evident in the H and HA groups (172.2 and 155.9 mL/m², respectively; both p<0.01) but not in the LA group (17.8 mL/m²; p=0.72). For the 8-hour dwell, UF did not differ significantly between ICO and 2.5% GD (15.8 mL/m²; 95% CI: −25.0–56.6; p=0.43).
Solute removal (urea nitrogen, creatinine, potassium, phosphate) was significantly higher with ICO during the 12-hour dwell (all p<0.05). One case of Grade 3 hyponatremia occurred but was deemed unrelated to ICO, and no serious adverse events were observed.

In pediatric PD, ICO demonstrated superior UF and solute removal than 2.5% GD during a 12-hour long-dwell exchange, particularly in patients with high peritoneal transport characteristics. ICO may therefore help optimize long-dwell PD performance in children with ESKD.

Kewords