Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony (NCT06390592) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony
24 participantsStarted 2026-06
Plain-language summary
Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed consent signed and dated by study patient and investigator/ authorised physician
* Minimum age of 18 years
* CKD patients with indication for renal replacement therapy
* Patients being treated with APD for at least 3 months
* Patients using the sleep•safe harmony PD cycler (version 3.1)
* Fluid status regularly monitored with Body Composition Monitor (BCM)
* Proper functioning catheter
* Intraperitoneal Pressure (IPP) ≤ 18 cm H2O
* Ability to understand the nature and requirements of the study
Exclusion Criteria:
* Any conditions which could interference with the patient's ability to comply with the study
* Previous participation in the same study
* 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
* Respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (FV) manipulation
* 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 90 days
What they're measuring
1
Total Kt/V urea
Timeframe: every 2 weeks, during the 6 weeks treatment