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Table 1 Inclusion and exclusion criteria for the study

From: A clinical study of efficacy and safety of the Carry Life UF system in continuous ambulatory peritoneal dialysis patients: protocol for a prospective, multicenter, randomized, crossover study

Inclusion criteria

Age ≥ 18 years.

 

Subjects with end-stage kidney disease (ESKD) treated with PD for at least three months.

 

A PD prescription of 2–4 CAPD dwells/day unchanged for a minimum of two weeks, with at least one 1.5–2 L, 2.27% glucose day dwell daily.

 

Subjects must be able to tolerate a 2 L PD fill volume for the peritoneal equilibration test (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 months.

 

Serum potassium > 6 mmol/L within the last three months.

 

Serum urea > 35 mmol/L within the last three months.

 

Clinical signs of dehydration.

 

Systolic blood pressure < 100 mmHg within the last month.

 

Known diagnosis of clinically significant aortic stenosis.

 

Clinical condition of unstable diabetes.

 

Subjects with a life expectancy of < six months.

 

Evidence of any other diseases or medical conditions that may interfere with the planned treatment or affect subject compliance.

 

Participation in clinical trials, interfering with the present study, within the previous month.

 

Anticipated living donor kidney transplantation within six months of screening.

 

Pregnant, breastfeeding, or women of childbearing potential who are not using an effective method of contraception (hormonal contraceptives or barrier contraceptive methods).