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

This clinical trial is looking at how different factors, like the amount of fluid used, how long the fluid stays in the body, and the sugar levels in that fluid, affect the amount of waste that can be removed in patients with chronic kidney disease who are using a specific type of dialysis called automated peritoneal dialysis (APD). The goal is to gather information that could help improve future predictions about how well this treatment works for patients.

To participate in this study, you need to be between 18 and 65 years old, have been on APD for at least three months, and have certain health measures that show your kidney treatment is working well. If you join the study, you will be closely monitored, and your information will be used to help researchers understand the best ways to improve treatment for kidney disease. It’s important to know that the study is not yet recruiting participants, and there are specific health conditions that may prevent someone from joining.

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")