Objectives: To investigate the efficacy and safety of single daily icodextrin exchange for initiation of incremental peritoneal dialysis (PD).
Subjects: Seventy-two incident PD patients.
Methods: A single-center randomized controlled trial.
Primary outcome: Change in residual kidney function in 48 weeks after recruitment.
male or female patients aged 18 to 75 years;
patients with chronic kidney disease stage 5 who are to start PD;
eGFR ≥ 5 ml/min;
urine output ≥ 800 ml/d.
documented anaphylaxis with icodextrin or glucose-based dialysate;
concomitant severe chronic diseases such as malignancy, hepatitis, severe cardiac diseases, etc.;
ongoing severe infection;
planned or ongoing pregnancy or lactation;
Parallel
Single daily icodextrin exchange
Other interventionPD initiation with single daily exchange of 2-liter icodextrin-based dialysis solution.
Conventional PD group
Other interventionPD is initiated with 2 to 3 exchanges of 2-liter glucose-based dialysis solution.
Residual kidney function
Change of residual kidney function in 48 weeks after PD initiation
Mortality
The endpoint was death. The censored events include transfer to permanent hemodialysis, recovery of renal function, loss to follow-up, transfer to other dialysis centers, or to the end of study.
Peritonitis-free survival
The endpoint was first episode of PD-related peritonitis. The censored events were death, transfer to permanent hemodialysis, recovery of renal function, loss to follow-up, transfer to other dialysis centers, or to the end of study.
Health-related quality of life
Change of health-related quality of life assessed using Kidney Disease Quality of Life-Short Form in 48 weeks after recruitment. The form generates a score of 0 to 100, which represents better quality of life by a higher value.
Volume status
Change of volume status (Overhydration assessed by Bioelectric Impedance Analysis, etc.) in 48 weeks after recruitment
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