Icodextrin dialysate in pediatric peritoneal dialysis

Phase 2

Recruiting

• Conditions: end-stage kidney disease; Kidney dysfunction, peritoneal dialysis; D007676

• Registration Number: JPRN-jRCTs031190125
• Lead Sponsor: Hamada Riku

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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)<br>2. Comparison of water removal volume (mL / m2) of Icodextrin dialysate and 2.5% sugar concentration dialysate at 8 hours retention<br>3. Comparison of water removal volume (mL / m2) by retention time (8 hours vs. 12 hours) of each dialysate<br>4. Comparison of solute removal ability and sugar absorption amount with Icodextrin dialysate and 2.5% sugar concentration dialysate