Abstract
Introduction: Peritoneal dialysis (PD) is a common renal replacement therapy for most children with end stage kidney disease (ESKD). Automated peritoneal dialysis (APD) is a method of PD using a cycler machine, suitable for overnight use during sleep, allowing minimal disruption to the daily activities of both children and caregivers. This is in contrast to continuous ambulatory peritoneal dialysis (CAPD), which necessitates daytime self-administration and can impact the quality of life for children receiving renal replacement therapy. Objectives: To investigate and compare the quality of life among pediatric ESKD patients undergoing APD and CAPD. Additionally, to explore and compare the incidence of infection-related complications associated with peritoneal dialysis, alterations in blood pressure, sleep problems, and changes in electrolyte balance within the body during APD and CAPD. Methods: This is an open-label randomized controlled trial conducted across 11 institutions. Volunteers include ESKD pediatric patients aged 1 to 18 years who are eligible for treatment under the national health security system. Patients undergoing long-term peritoneal dialysis were selected. Specifically, participants needed to reside in locations with electricity access and have proficiency in the Thai language. A total of 40 volunteers were required for each group. The study involved a 48-week follow-up of participants in both the APD and CAPD groups. Clinical data were collected. Quality of life was assessed using the PedQL, and health utilities were evaluated with the EQ-5D. Results: The study involved 30 volunteers in each of the APD and CAPD groups, with average ages of 10.5 (SD, 4.3) and 12.3 (SD, 3.1) years, respectively. Participants had been on peritoneal dialysis for an average of 14.9 and 15 months in the APD and CAPD groups, and gender distribution was similar in both groups. The most common cause of ESKD was renal hypoplasia (18.3%), followed by reflux nephropathy (15%). Of the participants who completed the study, 12 withdrew. Using the PedsQL, assessed by parents, there were no significant differences in the quality of life between the two groups in all aspects. However, self-reported assessments found that the social dimension scores were significantly higher in the APD group than the CAPD group at week 16, with statistical significance. Both groups exhibited a notable improvement in social, emotional, and overall scores at the end of the study but no significant differences were nevertheless found in other aspects of quality of life. The EQ-5D, assessed by both parents and patients themselves, did not reveal any significant differences between the two patient groups. The mixed-model repeated measure analysis did not find statistically significant differences in changes in both quality of life and benefits between the two groups. The study found a peritonitis rate of 0.34 cases per year, and there were no significant differences between the APD and CAPD groups. Blood chemistry changes and blood pressure changes over 48 weeks showed no differences between the two groups. Notably, the CAPD group had more hospitalizations for hypertensive urgency and/or emergency (12 cases) compared to the APD group (3 cases) (p < 0.01). In week 16, patients aged 6-12 years in the CAPD group had a significantly higher rate of excessive sleepiness (40.7%) compared to the APD group (16.7%) (p < 0.04). By week 48, patients aged 13-18 years in the APD group had longer daily sleep duration on both weekdays (10 hours) and weekends (10 hours) compared to the CAPD group (8.5 hours and 8 hours on weekdays and weekends, respectively) (p < 0.03). Discussion and conclusion: Quality of life score changes showed no statistically significant differences between the APD and CAPD groups. However, clinically significant improvements in quality of life scores were observed in the social, school, and overall dimensions for the APD group, as assessed by parents and self-assessment. These improvements exceeded the minimal clinically important difference for both PedsQL and EQ-5D in dialysis patients. In contrast, the CAPD group showed some improvement in scores but not to a statistically significant degree. The lack of significant differences in quality of life changes may be due to the limited sample size. It's worth noting that EQ-5D was not designed to evaluate children's quality of life and did not encompass school and social dimensions. Treatment with APD and CAPD did not differ significantly in the incidence of peritonitis due to infection. Changes in kidney function, blood chemistry levels, and blood pressure complications showed no significant differences between the two treatment methods. Nevertheless, hospitalization incidents for severe high blood pressure were significantly more common in the CAPD group than the APD group. Most patients experienced sleep problems, with significantly higher rates of excessive sleepiness in the CAPD group compared to the APD group, at 2.4 times higher. Also, the APD group had longer daily sleep hours on both regular and weekend days in patients aged 13-18 years compared to the CAPD group, which may be attributed to clinical significance.
