单位：[1]Graduate School of Dalian Medical University, Dalian, , China[2]Department of Nephrology, The First Affiliated Hospital of Dalian Medical University.Kidney Research Institute of Dalian Medical University, Dalian, , China大连医科大学附属第一医院[3]Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute ofNephrology, State Key Laboratory of Kidney Diseases, National Clinical ResearchCenter for Kidney Diseases, Beijing Key Laboratory of Kidney Disease Research,Beijing, China[4]Medical Research & Biometrics Center, Fuwai Hospital, National Center forCardiovascular Disease, Chinese Academy of Medical Sciences and Peking UnionMedical College, Beijing, China[5]School of Control Science and Engineering, Dalian University of Technology, Dalian,China[6]Blood Purification Center, The First Affiliated Hospital of Xi’an Jiaotong University,Xi'an, China[7]Division of Nephrology, Guangdong General Hospital, Guangdong Academy ofMedical Sciences, Guangzhou, China广东省人民医院[8]Department of Nephrology, Beijing Friendship Hospital Attached Capital MedicalUniversity, Beijing, China临床科室肾脏内科肾脏内科首都医科大学附属北京友谊医院[9]Department of Nephrology, West China Hospital of Sichuan University, Chengdu,China四川大学华西医院[10]Department of Nephrology, Zhongshan Hospital, Fudan University, Shanghai, China[11]Department of Nephrology, Dalian Municipal Central Hospital, Dalian, China大连市中心医院[12]Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University,Guangzhou, China院本部内科肾内科中山大学附属第一医院[13]Department of Nephrology, General Hospital of Shenyang Military Region,Shenyang, China[14]Department of Nephrology, General Hospital of Ningxia Medical University,Yinchuan, China[15]Department of Nephrology, Renji Hospital Affiliated to Shanghai Jiao TongUniversity School of Medicine, Shanghai, China[16]Department of Nephrology, Huashan Hospital, Fudan University, Shanghai, China[17]Department of Nephrology, Xijing hospital of The Fourth Military MedicalUniversity, Xi'an, China[18]Department of Nephrology, Guangdong General Hospital, Guangzhou, , China广东省人民医院[19]Department of Nephrology, General Hospital of Benxi Iron and Steel Co., Ltd,Benxi, China[20]Department of Nephrology, Daping Hospital Affiliated to Army Military MedicalUniversity, Chongqing, China[21]Department of Nephrology, Affiliated Zhong Shan Hospital of Dalian University,Dalian, China[22]Department of Nephrology, Lanzhou University Second Hospital, Lanzhou, China[23]Department of Nephrology, The First Affiliated Hospital of Harbin MedicalUniversity, Harbin, China[24]Department of Nephrology, The First Affiliated Hospital of Xinjiang MedicalUniversity, Urumchi, China[25]Department of Nephrology, Zhejiang Provincial People's Hospital, Hangzhou, ,China[26]Department of Nephrology, An Steel Group Hospital, Anshan, China[27]Department of Nephrology, The People’s Hospital of Zhengzhou University andHenan Provincial People’s Hospital, Zhengzhou, China[28]Department of Nephrology, The Second Affiliated Hospital of Harbin MedicalUniversity, Harbin, China[29]Department of Nephrology, General Hospital of Mining Industry Group FuXin,FuXin, China[30]Department of Nephrology, The First Hospital of China Medical University,Shenyang, China[31]Department of Nephrology, General Hospital Affiliated To Shenyang MedicalCollege, Shenyang, China[32]Department of Nephrology, Shengjing Hospital of China Medical University,Shenyang, China中国医科大学附属盛京医院[33]FibroGen, Inc, San Francisco, California, USA
Introduction Starting dialysis early or late both result in a low quality of life and a poor prognosis in patients undergoing haemodialysis. However, there remains no consensus on the optimal timing of dialysis initiation, mainly because of a lack of suitable methods to assess variations in dialysis initiation time. We have established a novel equation named DIFE (Dialysis Initiation based on Fuzzy-mathematics Equation) through a retrospective, multicentre clinical cohort study in China to determine the most suitable timing of dialysis initiation. The predictors of the DIFE include nine biochemical markers and clinical variables that together influence dialysis initiation. To externally validate the clinical accuracy of DIFE, we designed the assessment of DIFE (ADIFE) study as a prospective, open-label, multicentre, randomised controlled trial to assess the clinical outcomes among patients who initiate dialysis in an optimal start dialysis group and a late-start dialysis group, based on DIFE. Methods and analysis A total of 388 enrolled patients with end-stage renal disease will be randomised 1:1 to the optimal start dialysis group, with a DIFE value between 30 and 35, or the late-start dialysis group, with a DIFE value less than 30, using the Randomization and Trial Supply Management system. Participants will be assessed for changes in signs and symptoms, dialysis mode and parameters, biochemical and inflammatory markers, Subjective Global Assessment, Kidney Disease Quality of Life Short Form, Cognitive Assessment, medical costs, adverse events and concomitant medication at baseline, predialysis visiting stage and postdialysis visiting stage, every 12-24 weeks. The following data will be recorded on standardised online electronic case report forms. The primary endpoint is 3-year all-cause mortality. The secondary endpoints include non-fatal cerebrocardiovascular events, annual hospitalisation rate, quality of life, medical costs and haemodialysis related complications. Ethics and dissemination Ethical approval was obtained from the Ethics Committee of the First Affiliated Hospital of Dalian Medical University China (registration no: YJ-KY-2017-119) and the ethics committees of all participating centres. The final results of the ADIFE trial will be presented to the study sponsor, clinical researchers and the patient and public involvement reference group. Findings will be disseminated through peer-reviewed journals, Clinical Practice Guidelines and at scientific meetings.
基金：
special fund for National Health and Family Planning Commission (NHFPC) Scientific Research in the Public Welfare [201502023]
第一作者单位：[1]Graduate School of Dalian Medical University, Dalian, , China[2]Department of Nephrology, The First Affiliated Hospital of Dalian Medical University.Kidney Research Institute of Dalian Medical University, Dalian, , China
共同第一作者：
通讯作者：
通讯机构：[1]Graduate School of Dalian Medical University, Dalian, , China[2]Department of Nephrology, The First Affiliated Hospital of Dalian Medical University.Kidney Research Institute of Dalian Medical University, Dalian, , China
推荐引用方式(GB/T 7714)：
Chen Jilin,Liu Ying,Chen Xiangmei,et al.Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial[J].BMJ OPEN.2019,9(9):doi:10.1136/bmjopen-2018-023162.
APA：
Chen, Jilin,Liu, Ying,Chen, Xiangmei,Sun, Xuefeng,Li, Wei...&Lin, Hongli.(2019).Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial.BMJ OPEN,9,(9)
MLA：
Chen, Jilin,et al."Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial".BMJ OPEN 9..9(2019)
