Abstract: PUB195
Clinical Performance of the Therapy Option FlexPoint (Flexible Volume and Dwell Time Management) of the PD Cycler Sleep Safe Harmony
Session Information
Category: Dialysis
- 802 Dialysis: Home Dialysis and Peritoneal Dialysis
Authors
- Schmitt, Jana, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
- Rivera Gorrin, Maite, Hospital Universitario Ramon y Cajal, Madrid, Madrid, Spain
- De los Ríos, Tatiana, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
- Stauss-Grabo, Manuela, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
Background
While adequate removal of fluid, uremic toxins and sodium may be regarded as cornerstones of clinical homeostasis, modern peritoneal dialysis (PD) therapy should ideally deliver also on a number of other fronts that relate to lifestyle and quality of life.
FlexPoint therapy option – flexible volume and dwell time management – of the Fresenius PD cycler sleep safe harmony allows to shorten cycle phases where no effective dialysis takes place without compromising patient’s comfort and dialysis targets. The prescribed therapy is automatically adjusted within defined, medically acceptable limits for residual volume, inflow volume, dwell duration, as part of flexible management, without triggering alarms. In addition to medically reasonable default values, physicians can adapt the limit values for the individual options to the patient.
Methods
The study (NCT06390592) is an interventional, randomized, crossover trial designed to evaluate whether usage of the therapy option FlexPoint influences the efficacy of APD treatments, by assessing total Kt/V, mean daily ultrafiltration, as well as the hydration status of PD patients.
During the six-week clinical phase 24 patients are continuously treated with the sleep safe harmony PD-cycler according to their prescription. The clinical phase is divided into 3 study phases of 2 weeks each which only differ in the FlexPoint settings. The patient's treatment during the clinical phase will follow a randomized scheme of treatment sequences using a Williams 6*3 cross-over design.
To evaluate patient perspectives, questionnaires on quality of life and sleep are completed. Patient-reported outcomes and clinical data are recorded at baseline and the end of the second treatment week during the clinical phase.
Results
For primary analysis, three pairwise comparisons between the treatment settings will be performed to assess equivalence with respect to total Kt/V. All secondary efficacy and safety variables are summarized descriptively by treatment setting and where appropriate also for pairwise treatment differences.
Conclusion
The study aims to demonstrate that individualized volume and dwell time management during the treatment does not influence the PD treatment efficacy but improves the patient’s well-being.
Funding
- Commercial Support – Fresenius Medical Care Deutschland GmbH