Safety, Effectiveness, and Manipulability of Peritoneal Dialysis Machines Made in China: A Randomized, Crossover, Multicenter Clinical Study
Xue-Ying Cao1, Ya-Ni He2, Jian-Hui Zhou1, Shi-Ren Sun3, Li-Ning Miao4, Wen Chen5, Jing-Ai Fang6, Ming Wang7, Nian-Song Wang8, Hong-Li Lin9, Jian Liu10, Zhao-Hui Ni11, Wen-Hu Liu12, Yu Na13, Jiu-Yang Zhao14, Zhi-Yong Guo15, Hong-Guang Zheng16, Wei Shi17, Geng-Ru Jiang18, Guang-Yan Cai1, Xiang-Mei Chen1
1 Department of Nephrology, Chinese People's Liberation Army General Hospital, Chinese People's Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China
2 Department of Nephrology, Daping Hospital, Army Military Medical University, Chongqing 400042, China
3 Department of Nephrology, Xijing Hospital, The Fourth Military Medical University, Xi'an, Shaanxi 710032, China
4 Department of Nephrology, Second Hospital of Jilin University, Changchun, Jilin 130041, China
5 Department of Nephrology, Hainan Provincial Agricultural Reclamation General Hospital, Haikou, Hainan 570311, China
6 Department of Nephrology, First Affiliated Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China
7 Department of Nephrology, Hangzhou First People's Hospital, Hangzhou, Zhejiang 310006, China
8 Department of Nephrology and Rheumatology, Affiliated Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai 200233, China
9 Department of Nephrology, First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China
10 Department of Nephrology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang 830054, China
11 Department of Nephrology, Renji Hospital, Shanghai Jiao Tong University, Shanghai 200127, China
12 Department of Nephrology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
13 Department of Nephrology, The 306th Hospital of People's Liberation Army, Beijing 100101, China
14 Department of Nephrology, The Second Affiliated Hospital of Dalian Medical University, Dalian Medical University, Dalian, Liaoning 116023, China
15 Department of Nephrology, Changhai Hospital, The Second Military Medical University, Shanghai 200433, China
16 Department of Nephrology, People's Liberation Army General Hospital of Shenyang Military Region, Shenyang, Liaoning 110016, China
17 Department of Nephrology, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong 510080, China
18 Department of Nephrology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China
Dr. Xiang-Mei Chen
Department of Nephrology, Chinese People's Liberation Army General Hospital, Chinese People's Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853
Source of Support: None, Conflict of Interest: None
Background: Automated peritoneal dialysis (APD) can cater to individual needs, provide treatment while asleep, take into account the adequacy of dialysis, and improve the quality of life. Currently, independent research and development of APD machines made in China are more conducive to patients. A randomized, multicenter, crossover study was conducted by comparing an APD machine made in China with an imported machine. The safety, effectiveness, and manipulability of the two machines were compared.
Methods: Two hundred and sixty patients who underwent peritoneal dialysis (PD) on a regular basis in 18 centers between August 2015 and February 2016 were included. The inclusion criteria include age ≥18 years and PD ≥30 days. The exclusion criteria were as follows: hemodialysis; exit site or tunnel infection; and peritonitis ≤30 days. The patients were randomly divided into Group A, who were first treated with a FM machine made in China, then changed to an imported machine; and Group B, who were treated using the reverse sequence. APD treatment was performed with 10 L/10 h and 5 cycles of exchange. After 72 h, the daily peritoneal Kt/V, the accuracy of the injection rate, accuracy of the injection temperature, safety, and manipulability of the machine were assessed. Noninferiority test was conducted between the two groups.
Results: The daily peritoneal Kt/V in the APD machine made in China and the imported APD machine were 0.17 (0.14, 0.25) and 0.16 (0.13, 0.23), respectively. There was no significant difference between the groups (Z = 0.15, P = 0.703). The lower limit of the daily Kt/V difference between the two groups was 0.0069, which was greater than the noninferiority value of −0.07 in this study. The accuracy of the injection rate and injection temperature was 89.7% and 91.5%, respectively, in the domestic APD machine, which were both slightly better than the accuracy rates of 84.0% and 86.8% in the imported APD machine (89.7% vs. 84.0%, P = 0.2466; 91.5% vs. 86.8%, P = 0.0954). Therefore, the APD machine made in China was not inferior to the imported APD machine. The fuselage of the imported APD machine was space-saving, while the APD machine made in China was superior with respect to body mobility, man-machine dialog operation, alarm control, and patient information recognition.
Conclusions: The FM machine made in China was not inferior to the imported APD machine. In addition, the FM machine made in China had better operability.
Trial Registration: Clinicaltrials.gov, NCT02525497; https://clinicaltrials.gov/ct2/results?cond=&term=NCT02525497&cntry=& state=&city=&dist=.