NCT04017572

Optimized vs. Standard Automated Peritoneal Dialysis Regimens Study

Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Lund University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is designed to evaluate the theoretical prediction of a lower glucose absorption in optimized automated peritoneal dialysis regimes. Patients will receive both a standard 6 x 2L 1.36% glucose regime or an optimized 7 x 2 L 2.27% glucose + 5 x 2 L 0.1% glucose regime in a crossover fashion.

Detailed description

Automated peritoneal dialysis (APD) is a rapidly growing, home-based kidney replacement therapy promoting patient autonomy, and is associated with lower societal costs compared to hemodialysis. However, in light of the growing number of diabetic patients on PD, the unwanted glucose absorption during APD is problematic. Recent results (Öberg CM, Rippe B, 2017, see references), using a theoretical model of APD, indicate that large reductions in glucose absorption are possible by using specialized so-called optimized bi-modal treatment regimes having "UF cycles" using a higher glucose concentration (e.g. 2.27% glucose) and "Clearance cycles" using a low glucose concentration (e.g. 0.1% glucose).

Conditions

• End Stage Kidney Disease
• Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

Type	Name	Description
PROCEDURE	Automated peritoneal dialysis (APD)	Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler.

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2019-07-12
• Last updated: 2021-02-12

Locations

1 site across 1 country: Argentina