Carry Life@ UF System Clinical Study (NCT05874804) | Clinical Trial Compass
CompletedNot Applicable
Carry Life@ UF System Clinical Study
Italy, Sweden28 participantsStarted 2023-09-19
Plain-language summary
The Carry Life UF system performs peritoneal ultrafiltration by adding glucose to the low glucose strength (1.36%) peritoneal dialysis fluid which has been instilled into the peritoneal cavity prior to the connection of the device. By maintaining a stable glucose concentration in the intraperitoneal fluid during the 5-hour treatment, the ultrafiltration can be increased compared to a standard CAPD dwell.
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
✓. Age ≥ 18 years.
✓. Subjects with ESKD treated with PD for at least three (3) months.
✓. A PD prescription of 2-4 CAPD dwells/day unchanged for a minimum of two (2) weeks, with at least one 1.5-2L, 2.27% glucose day dwell daily.
✓. Subjects must be able to tolerate a 2 L PD fill volume for the PET.
✓. Subjects using the Baxter PD system with a MiniCap transfer set.
✓. In the opinion of the Investigator, the subject has the capacity to learn how to use the Carry Life® UF system or has a caregiver who can do so.
✓. Obtained written consent to participate in the study.
Exclusion criteria
✕. A PD prescription including a regular 3.86% glucose day dwell.
✕. An episode of peritonitis within the last three (3) months.
✕. Serum potassium \> 6 mmol/l within the last three (3) months.
✕. Serum urea \> 35 mmol/l within the last three (3) months.
✕. Clinical signs of dehydration.
✕. Systolic blood pressure \< 100 mmHg within the last month.