Influence of Variable Inflow Volume, Dwell Duration and Glucose Concentration on Ultrafiltration Volume in APD Patients

Launched by FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH · Jun 3, 2024

Keywords

ClinConnect Summary

The primary objective of this study is:

- UFV determined per defined dwells with variable dwell duration, dialysis fluid glucose composition and inflow volumes

The secondary objectives of this study are:

* Mean daily UFV
* Defined laboratory parameter like urea, creatinine, glucose, sodium determined in blood and dialysate during the extended PET (in dialysate additionally determination: phosphate, albumin removal)
* Treatment parameter: performed treatment duration and volume
* Fluid status measured by Body Composition Monitor (BCM)
* Manual IPP determination during the extended PET: At...

Gender

ALL

Eligibility criteria

• 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 patients having dwell exchanges throughout the day ("day dwell")

Trial Officials