Hospital-based Health Technology Assessment of central dialysis fluid delivery system for hemodialysis patients

Background This study aims to evaluate the safety, effectiveness, and economic value of central dialysis fluid delivery system (CDDS) compared to single-patient dialysis fluid delivery system (SPDDS) for hemodialysis patients through hospital-based health technology assessment (HB-HTA). The findings provide a scientific basis for the hospital adoption and clinical application of CDDS. Methods Using the HB-HTA approach, we assessed the clinical value (safety and effectiveness) and economic value (cost and cost-effectiveness) of CDDS compared to SPDDS. Clinical value evaluation was based on evidence from a systematic literature review, while economic value was assessed through micro-costing from 3 hospitals. This included cost estimation for CDDS and SPDDS and an economic efficiency analysis under various scales of hemodialysis machine configurations. The analysis encompassed total costs, cost composition, cost savings, and their respective components to identify application scenarios where CDDS demonstrated economic value. Results Three studies compared the clinical effects of CDDS and SPDDS. Endotoxin Levels: Hassan et al. (2023) found significantly lower serum endotoxin levels in dialysis fluid in the CDDS group compared to SPDDS (0.05 vs. 0.11 EU/ml, P = 0.001). Ahmed et al. (2024) demonstrated significantly lower pre-dialysis (0.07 ± 0.05 vs. 0.20 ± 0.07 EU/ml, P < 0.001) and post-dialysis (0.04 ± 0.02 vs. 0.15 ± 0.03 EU/ml, P < 0.001) serum endotoxin levels in the CDDS group versus SPDDS. Inflammatory Markers: Hassan et al. (2023) showed a significant reduction in CRP levels at 3 months in the CDDS group (9.8 vs 4.7 mg/dL, P < 0.001), whereas no change was observed in the SPDDS group (9.6 vs 9.1 mg/dL, P = 0.54). Ni et al. (2024) reported a significant decrease in hs-CRP levels over time in the CDDS group (β _CDDS = -0.793) compared to an increase in the SPDDS group (β _SPDDS  = 0.791), with a significant timegroup interaction effect (F _{Time*CDDS group} = 13.389, P < 0.001). Anemia-Related Outcomes: Hassan et al. (2023) noted significant improvements in hemoglobin levels in the CDDS group(10.6 vs 12.3 mg/dL), whereas no change was observed in the SPDDS group (10.3 vs 10.0 mg/dL, P = 0.149). Hassan et al. (2023) showed a significant reduction in Erythropoietin Resistance Index (ERI) at 3 months in the CDDS group (9.7 vs 3.1, P<0.001), whereas significant improvements was observed in the SPDDS group (10.2 vs 12.3 mg/dL, P = 0.047). There are significant difference in ERI between the CDDS and SPDDS groups (P<0.001). Renal function and nutritional indicators: Ni et al. (2024) showed that no significant differences were observed in albumin or β2-microglobulin levels (β2-microglobulin: β = -0.658, F _{Time* CDDS group} = 1.228, P = 0.269; albumin: β = 0.012, F _{Time* CDDS group} = 1.429, P = 0.233). In terms of economic value, compared to SPDDS, CDDS reduced costs for a dialysis center equipped with 6 hemodialysis machines operating 2 shifts daily, serving 12 patients per day, achieving a 0.05% cost reduction. When the number of hemodialysis machines increased from 6 to 50, the cost reduction rate for CDDS increased from 0.05–21.08%, indicating greater economic benefits for larger-scale dialysis centers. For a dialysis center with 50 machines, CDDS saved approximately 11.61 USD per treatment session and 362,362 USD per year. Cost savings mainly arose from reductions in consumable costs (74%) and labor costs (24%). Conclusion Compared to SPDDS, CDDS improved the microinflammatory state and renal anemia outcomes in hemodialysis patients, potentially offering long-term clinical advantages. Under specific conditions, CDDS demonstrated economic value by reducing consumable and labor costs, making it cost-effective for dialysis centers with 6 or more machines serving at least 12 patients daily. The main sources of cost savings were reductions in consumable and labor costs, with clinical engineers playing an important role in implementation. In China, CDDS is suitable for promotion in dialysis centers of a certain scale.