Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony
The primary objective of this study are: * to investigate and compare the clinical performance of standard (default) FlexPoint settings to minimum FlexPoint settings and to the maximum value for permitted peritoneal residual volume of FlexPoint settings of the PD cycler sleep•safe harmony in the treatment of PD patients. * to assess whether usage of the settings of the therapy option FlexPoint (flexible volume and dwell time management) of the PD cycler sleep•safe harmony that deviate from the system default and from former sleep•safe settings, influences the efficacy of APD treatments as well as the hydration status (by using BCM) of PD patients. The secondary objectives of this study are: * Patients´ Quality of Life (QoL) * Number of alarms * To investigate the effects on solute removal * To investigate the tolerability of the FlexPoint therapy options * Adverse events / SAE
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Patients are treated continuously during Peritoneal dialysis with the PD cycler sleep•safe harmony with different FlexPoint settings. According to their randomization the patients are treated with Treatment A, B or C in a different order: * standard (default) FlexPoint settings (Treatment A) * minimum value FlexPoint settings (Treatment B) * maximum value for permitted peritoneal residual volume (50%) of FlexPoint settings (Treatment C)
Total Kt/V urea
Measurement of solute removal during peritoneal dialysis focuses on urea
Time frame: every 2 weeks, during the 6 weeks treatment
Mean daily ultrafiltration (UF)
Daily ultrafiltration reached by the patient during peritoneal dialysis
Time frame: every day, during the 6 weeks treatment
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