Zhu Changhao, Ding Lingling, Lan Naiying, Zeng Fanzhou, Ye Dan, Wang Hao, Yang Bo
Department of Nephrology, Naval Medical Center of PLA, Naval Medical University, Shanghai, China.
BMC Nephrol. 2025 May 2;26(1):222. doi: 10.1186/s12882-025-04148-6.
End-stage renal disease (ESRD) is associated with significant morbidity and mortality, with patients often experiencing micronutrient deficiencies due to dialysis treatments. Hemodiafiltration with Endogenous Reinfusion (HFR) is a novel dialysis modality that combines diffusion, convection, and adsorption mechanisms to remove uremic toxins while potentially preserving essential nutrients. This study aims to assess the impact of HFR on micronutrient levels and removal rates in patients undergoing maintenance hemodialysis (HD).
This is a single-center, open-label, randomized controlled trial. Adult patients on maintenance HD will be randomized to two treatment arms: Arm A (Hemodiafiltration (HDF) followed by HFR) and Arm B (HFR followed by HDF), with a two-week washout period between treatments. Blood samples will be collected pre- and post-treatment to measure trace elements, water-soluble vitamins, and fat-soluble vitamins. Statistical analyses will include paired t-tests and Wilcoxon signed-rank tests for within-group comparisons, and repeated measures ANOVA for between-group differences, adjusting for potential confounders.
This study will evaluate whether HFR offers superior retention of micronutrients compared to traditional HDF therapies, which may contribute to improved clinical outcomes for ESRD patients. Findings could provide valuable insights into the role of HFR in optimizing nutritional status and reducing dialysis-related complications. The cross-over design minimizes patient variability, enhancing the reliability of comparisons between treatment modalities.
This trial is registered with the Chinese Clinical Trial Registry (ChiCTR2500096698).
终末期肾病（ESRD）与严重的发病率和死亡率相关，患者常因透析治疗而出现微量营养素缺乏。内源性再输注血液透析滤过（HFR）是一种新型透析方式，它结合了扩散、对流和吸附机制来清除尿毒症毒素，同时可能保留必需营养素。本研究旨在评估HFR对维持性血液透析（HD）患者微量营养素水平和清除率的影响。
这是一项单中心、开放标签、随机对照试验。接受维持性HD的成年患者将被随机分为两个治疗组：A组（先进行血液透析滤过（HDF），然后进行HFR）和B组（先进行HFR，然后进行HDF），两组治疗之间有两周的洗脱期。在治疗前后采集血样，以测量微量元素、水溶性维生素和脂溶性维生素。统计分析将包括组内比较的配对t检验和Wilcoxon符号秩检验，以及组间差异的重复测量方差分析，并对潜在混杂因素进行调整。
本研究将评估与传统HDF疗法相比，HFR是否能更好地保留微量营养素，这可能有助于改善ESRD患者的临床结局。研究结果可为HFR在优化营养状况和减少透析相关并发症中的作用提供有价值的见解。交叉设计可最大限度地减少患者变异性，提高治疗方式之间比较的可靠性。
本试验已在中国临床试验注册中心注册（ChiCTR2500096698）。
