Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients (SDM-ART trial): study protocol for randomized clinical trial

Abstract

Background: The medium cutoff (MCO) dialyzer increases the removal of several Background: Patients with chronic kidney disease (CKD) should be educated about their condition so that they can initiate dialysis at the optimal time and make an informed choice between dialysis modalities. Shared decision-making (SDM) empowers patients to select their own treatment and improves patient outcomes. This study aimed to evaluate whether SDM affects the choice of renal replacement therapy among CKD patients. Methods: This is a multicenter, open-label, randomized, pragmatic clinical trial. A total of 1,194 participants with CKD who are considering renal replacement therapy were enrolled. The participants will be randomized into three groups in a 1:1:1 ratio: the conventional group, extensive informed decision-making group, and SDM group. Participants will be educated twice at months 0 and 2. Videos and leaflets will be provided to all patients. Patients in the conventional group will receive 5 minutes of education at each visit. The extensive informed decision-making group will receive more informed and detailed education using intensive learning materials for 10 minutes each visit. Patients in the SDM group will be educated for 10 minutes each visit according to illness perception and item-based analysis. The primary endpoint is the ratio of hemodialysis to peritoneal dialysis and kidney transplantation among the groups. Secondary outcomes include unplanned dialysis, economic efficiency, patient satisfaction, patient evaluation of the process, and patient adherence. Discussion: The SDM-ART is an ongoing clinical study to investigate the effect of SDM on the choice of renal replacement therapy in patients with CKD.middle molecules more effectively than high-flux hemodialysis (HD). However, comparative data addressing the efficacy and safety of MCO dialyzers vs. postdilution hemodiafiltration (HDF) in Korean patients are lacking. Methods: Nine patients with chronic HD were included in this pre-post study. Patients underwent HD with an MCO dialyzer for 4 weeks, followed by a 2-week washout period using a high-flux dialyzer to minimize carryover effects, and then turned over to postdilution HDF for 4 weeks. Reduction ratios and differences in the uremic toxins before and after dialysis were calculated from the MCO dialysis, postdilution HDF, and high-flux HD. In the in vitro study, EA.hy926 cells were incubated with dialyzed serum. Results: Compared to postdilution HDF, the MCO dialyzer achieved significantly higher reduction ratios for larger middle molecules (myoglobin, kappa free light chain [κFLC], and lambda FLC [λFLC]). Similarly, the differences in myoglobin, κFLC, and λFLC concentrations before and after the last dialysis session were significantly greater in MCO dialysis than in postdilution HDF. The expression of Bax and nuclear factor κB was decreased in the serum after dialysis with the MCO dialyzer than with HDF. Conclusion: Compared with high-volume postdilution HDF, MCO dialysis did not provide greater removal of molecules below 12,000 Da, whereas it was superior in the removal of larger uremic middle molecule toxins in patients with kidney failure. Moreover, these results may be expected to have an anti-apoptotic effect on the human endothelium.