Influence of Variable Inflow Volume, Dwell Duration and Glucose Concentration on Ultrafiltration … (NCT06443021) | Clinical Trial Compass
WithdrawnNot Applicable
Influence of Variable Inflow Volume, Dwell Duration and Glucose Concentration on Ultrafiltration Volume in APD Patients
Stopped: Internal decision
0Started 2025-10
Plain-language summary
The purpose of the current investigation is to provide proof of concept for a future approach to improve UF prediction accuracy. While building on the ideas of the past, the concept is augmented by leveraging additional diagnostic technologies and digital data analytics methodologies.
Who can participate
Age range18 Years
SexALL
See this in plain English?
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/ authorized physician
* Patients between 18-65 of age
* Chronic kidney disease (CKD) patients being treated with nocturnal APD for at least 3 months
* Ability to understand the nature and requirements of the study
* Total Kt/V ≥ 1.7 (counting from recruitment of the patient the measurement should not be older than 3 months)
* APD patients using sleep•safe PD-cycler or sleep•safe harmony PD-cycler with an IPP ≤ 18 cm H2O for the fill volume of 120%
Exclusion Criteria:
* Any condition which could interfere with the patient's ability to comply with the study
* Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
* Patients who have been subject to 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
* Patients suffering from uncontrolled/ not well adjustable diabetes
* Recent history of drain related problems, catheter malfunction, or frequent alarms during treatment
* Patients with uncontrolled hypertension and/ or previous history of vascular instability during PD
* Patients treated with intermittent APD
* Participation in an interventional clinical study during the preceding 30 days
* Previous participation in the same study
* APD pa…
What they're measuring
1
Ultrafiltration volume (UFV)
Timeframe: every day during the 11 weeks treatment