Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): study protocol for a randomized controlled crossover trial

Abstract

Background: It has been estimated that automated peritoneal dialysis (APD) is currently the fastest growing renal replacement therapy in the world. However, in light of the growing number of diabetic patients on peritoneal dialysis (PD), the unwanted glucose absorption during APD remains problematic. Recent results, using an extended 3-pore model of APD, indicated that large reductions in glucose absorption are possible by using optimized bi-modal treatment regimens, having "UF cycles" using a higher glucose concentration, and "Clearance cycles" using a low concentration or, preferentially, no glucose. The present study is designed to test the theoretical prediction of a lower glucose absorption using these novel regimes.

Methods: This study is a randomized single-center, open-label, prospective study. Prevalent PD patients between 18 and 75 years old without known catheter problems or recent peritonitis are eligible for inclusion. Patients are allocated to a first treatment session of either standard APD (6 × 2 L 1.36% over 9 h) or optimized APD (7 × 2 L 2.27% + 5 × 2 L 0.1% over 8 h). A second treatment session using the other treatment will be performed in a crossover fashion. Samples of the dialysis fluid will be taken before and after the treatment, and the volume of the dialysate before and after the treatment will be carefully assessed. The primary endpoint is difference in glucose absorption between the optimized and standard treatment. Secondary endpoints are ultrafiltration, sodium removal, Kt/V urea, and Kt/V Creatinine. The study will be closed when a total of 20 patients have successfully completed the interventions or terminated according to interim analysis. A Monte Carlo power analysis shows that the study has 80% power to detect a difference of 10 g (in line with that of theoretical results) in glucose absorption between the two treatments in 10 patients.

Discussion: The present study is the first clinical investigation of optimized bi-modal treatments proposed by recent theoretical studies.

Trial registration: ClinicalTrials.gov identifier: NCT04017572. Registration date: July 12, 2019, retrospectively registered.

Keywords: Automated peritoneal dialysis; Glucose absorption; Metabolic cost; Renal replacement therapy.

Conflict of interest statement

Competing interestsCMÖ has worked as a consultant and received speakers’ honoraria from the Baxter Healthcare Corporation. KB is currently pursuing a master thesis project in collaboration with Gambro Lundia AB (part of Baxter Healthcare Corporation).

© The Author(s) 2020.

Figures

Fig. 1

Detailed enrollment and allocation flowchart for the Optimized vs. Standard APD regimens (OptiStAR) study

Fig. 2

Intra-peritoneal volume as a function of treatment time in hours for a a standard 9 h 6 × 2 L 1.36% regime (dwell time 71 min) vs. b an modified optimized 7 × 2.27% + 5 × 0% APD regime (dwell time 20 min)