臨床研究等提出・公開システム

Superiority test of icodextrin dialysate for 2.5% glucose dialysate in long-term retention of pediatric peritoneal dialysis.

Icodextrin dialysate in pediatric peritoneal dialysis ( ICO-PPD)

25

One case was discontinued before initiation, and 24 cases started the intervention. There were 13 male and 11 female patients. The median age was 4 years, with 13 cases under 6 years and 11 cases 6 years or older. Peritoneal equilibration test (PET) categories: H/HA in 20 cases and LA/A in 4 cases.

Of the 25 registered cases, 1 was discontinued before initiation, and 24 initiated the intervention. One case was discontinued during the intervention, and 23 were completed.

Hyponatremia Grade 3 (non-severe, no causality, recovered) 1 case. No Grade 3 or higher abnormal test values for AST or ALT. Grade 1 abnormal test values for LDH in 4 cases with 2.5% glucose solution and 2 cases with icodextrin solution.

Primary: Fluid removal per body surface area after 12 hours of storage (icodextrin solution -2.5% dialysis), average value 136.9 mL/m2, p=0.0001. Difference between groups p=0.0001. Secondary 1: Fluid removal per body surface area after 12 hours of storage by PET category (icodextrin solution-2.5% dialysis) D/P-cr=H, 172.2 mL/m2, p=0.0042. D/P-cr=HA, 155.9 mL/m2, p=0.0065.D/P-cr=LA, 17.75 mL/m2, p=0.7172. Secondary 2: Fluid removal per body surface area after 8 hours of storage (icodextrin solution-2.5% dialysis), mean value 15.8 mL/m2, p=0.4313. Secondary 3: Fluid removal per body surface area (8 hours-12 hours). 2.5% glucose solution, 114.7 mL/m2, p<0.0001. Icodextrin solution, 5.5 mL/m2, p=0.7099. Secondary endpoint 4: Solute removal after 12 hours of retention (icodextrin solution vs. 2.5% glucose solution). Urea nitrogen, creatinine, potassium, and phosphorus were all higher in the icodextrin solution group. (p<0.05)

Differences between groups were detected, suggesting that icodextrin solution may have superior performance to 2.5% glucose solution in terms of fluid removal and solute removal at 12 hours of storage.

July. 15, 2025

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs031190125

Hamada Riku

Tokyo metropolitan children's medical center

2-8-29, Musashidai, Fuchu-shi, Tokyo

riku_hamada@tmhp.jp

Hamada Riku

Tokyo metropolitan children's medical center

2-8-29, Musashidai, Fuchu-shi, Tokyo

+81-42-300-5111

riku_hamada@tmhp.jp

Complete

Oct. 29, 2019

Interventional

randomized controlled trial

open(masking not used)

active control

crossover assignment

treatment purpose

1. Pediatric peritoneal dialysis patients
2. Age under 18 years at the time of consent
3. Patients who have been 3 months or more since the introduction of peritoneal dialysis
4. Provide written informed consent by legal guardian

1. Patient within 3 months after peritonitis
2. Patients within 3 months after surgery to operate the peritoneum
3. Intraperitoneal adhesions or compartment syndromes that make it difficult to inject the prescribed injection volume
4. Patients whose attending physicians judged this study to be inappropriate

Both

end-stage kidney disease

Use of Icodextrin dialysate

Kidney dysfunction, peritoneal dialysis

Medication, Treatment

D007676

Comparison of the amount of water removalper body surface area (mL/m2) of Icodextrin dialysate and 2.5% sugar concentration dialysate at 12 hours retention

1. Comparison of water removal volume (mL / m2) of Icodextrin dialysate and 2.5% sugar concentration dialysate by difference in peritoneal function (peritoneal equilibrium test category)
2. Comparison of water removal volume (mL / m2) of Icodextrin dialysate and 2.5% sugar concentration dialysate at 8 hours retention
3. Comparison of water removal volume (mL / m2) by retention time (8 hours vs. 12 hours) of each dialysate
4. Comparison of solute removal ability and sugar absorption amount with Icodextrin dialysate and 2.5% sugar concentration dialysate

+81-3-3964-1141

Aug. 09, 2019

none