Abstract: SA-PO412
Controlling Sodium Balance in Maintenance Hemodialysis (MHD) Treatment: Study Protocol of a Randomized Controlled Registration Trial
Session Information
- Hemodialysis and Frequent Dialysis - 2
October 26, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Pang, Hui Hua, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital Baoshan Branch, Shanghai, Shanghai, China
- Gu, Leyi, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital Baoshan Branch, Shanghai, Shanghai, China
- Zuo, Li, Peking University People's Hospital, Beijing, China
- Ding, Jiaxiang, Peking University International Hospital, Beijing, China
- Wang, Lihua, Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China
- Zhang, Hongtao, Henan Provincial People's Hospital, Zhengzhou, Henan, China
- Wang, Liang, Wuxi People's Hospital, Wuxi, Jiangsu, China
- Maierhofer, Andreas, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
- Braun, Jennifer, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
- Stauss-Grabo, Manuela, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
- Qi, Weiwei, Fresenius Medical Care Shanghai Co Ltd, Shanghai, Shanghai, China
- Lin, Qing, Fresenius Medical Care Shanghai Co Ltd, Shanghai, Shanghai, China
- Guo, Yuanying, Fresenius Medical Care Shanghai Co Ltd, Shanghai, Shanghai, China
- Ho, Kakiu, Fresenius Medical Care Asia Pacific Ltd, Hong Kong, Hong Kong
Background
Restoring and controlling fluid volume homeostasis remains a challenge in patients with end-stage kidney disease. Na plays an important role in this process. However, most MHD patients are treated with a fixed dialysate Na concentration, potentially resulting in intradialytic plasma Na shifts. Recently it has been demonstrated these shifts can be minimized by application of a Na control algorithm. The 6008 dialysis machine (Fresenius Medical Care) enables monitoring and control of intradialytic Na fluxes between dialysate and plasma.
Methods
We report the protocol of a multicenter, open-labelled, randomized, superiority registration trial with parallel groups and balanced randomization with a 1:1 ratio. The trial plans to enroll 136 -MHD adult patients with pre-dialysis plasma Na from last 3 routine tests between 130 to 150 mmol/L. After informed consent, patients will be randomized into two groups and stratified with centers and the pre-dialysis plasma Na concentration. The control group will receive dialysate Na concentration set according to current center practice by 5008 series machines (Fresenius Medical Care). The investigational group will receive zero diffusive Na balance setting on 6008 machines. All subjects receive 2-times high-flux HD and 1-time post-hemodiafiltration in a week. Other dialysis treatment parameters will be set per prescription.
The primary outcome of this study will be the correlation between the intradialytic average dialysate Na concentration and the average pre-dialysis plasma Na concentration The main outcome will be reflected by the comparison of the value of the correlation coefficient R in both groups.
Results
The expectation is that applying zero diffusive Na control on 6008 machine results in a better correlation between the average dialysate Na concentration and the average pre-dialysis plasma Na concentration than with current center practice.
Conclusion
This will provide evidence that the Na control function individualizes dialysate Na prescription and minimizes the impact of diffusive Na transfer on plasma Na concentration during hemodialysis. This study is ongoing and will be completed in 2027.
Funding
- Commercial Support – Fresenius Medical Care