Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers

Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers

The study has been designed in order to investigate the performance and safety of the new Silencia PD cycler including the Silencia tubing system in comparison to the PD-Night and Homechoice PD cycler which are both well-established PD cyclers.

Inclusion Criteria:

• Informed consent signed and dated by study patient and investigator/authorised physician
• CKD patients being treated with APD for at least 3 months
• Minimum age of 18 years
• Body weight ≥ 40 kg
• Fluid status regularly monitored with Body Composition Monitor (BCM)
• Patients planned to change to the Silencia PD cycler
• Proper functioning catheter
• Intraperitoneal Pressure (IPP) ≤ 18 cm H2O for the maximum of TAVO parameter "permitted patient volume"
• Ability to understand the nature and requirements of the study

Exclusion Criteria:

• Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
• Patients receiving polyglucose containing PD solution
• Any conditions which could interfere with the patient's ability to comply with the study
• Patients who suffer from peritonitis/exit site infection during the last 4 weeks
• Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period
• Life expectancy < 3 months
• Participation in an interventional clinical study during the preceding 30 days
• Previous participation in the same study