Chen Jilin, Liu Ying, Chen Xiangmei, Sun Xuefeng, Li Wei, Yang Wang, Li Ping, Sun Ximing, Wang Degang, Jiang Hongli, Shi Wei, Liu Wenhu, Fu Ping, Ding Xiaoqiang, Chang Ming, Liu Shuxin, Yang Xiao, Cao Ning, Chen Menghua, Ni Zhaohui, Chen Jing, Sun Shiren, Liang Xinling, Wang Huimin, He Yani, Gao Bihu, Wang Jianqin, Hao Lirong, Liu Jian, Li Suhua, He Qiang, Liu Hongmei, Yi Na, Shao Fengmin, Jiao Jundong, Ma Yuhuan, Yao Li, Sun Yi, Li Detian, Szczech Lynda, Fang Ming, Odeh Zach, Lin Hongli
Graduate School of Dalian Medical University, Dalian, Liaoning, China.
Department of Nephrology, The First Affiliated Hospital of Dalian Medical University. Kidney Research Institute of Dalian Medical University, Dalian, Liaoning, China.
BMJ Open. 2019 Sep 8;9(9):e023162. doi: 10.1136/bmjopen-2018-023162.
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.
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.
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.
ClinicalTrial.gov. Registry (NCT03385902); pre-results.
过早或过晚开始透析都会导致血液透析患者生活质量低下和预后不良。然而，对于透析开始的最佳时机仍未达成共识，主要是因为缺乏评估透析开始时间变化的合适方法。我们通过在中国进行的一项回顾性、多中心临床队列研究，建立了一个名为DIFE（基于模糊数学方程的透析起始）的新方程，以确定透析开始的最合适时机。DIFE的预测因素包括九个生化标志物和临床变量，它们共同影响透析开始。为了外部验证DIFE的临床准确性，我们将评估DIFE（ADIFE）研究设计为一项前瞻性、开放标签、多中心、随机对照试验，以评估基于DIFE在最佳开始透析组和延迟开始透析组开始透析的患者的临床结局。
使用随机化和试验供应管理系统，将总共388名入组的终末期肾病患者按1:1随机分配至最佳开始透析组（DIFE值在30至35之间）或延迟开始透析组（DIFE值小于30）。在基线、透析前访视阶段和透析后访视阶段，每12 - 24周对参与者进行体征和症状、透析模式和参数、生化和炎症标志物、主观全面评估、肾脏病生活质量简表、认知评估、医疗费用、不良事件和伴随用药的变化评估。以下数据将记录在标准化的在线电子病例报告表上。主要终点是3年全因死亡率。次要终点包括非致命性心脑血管事件、年度住院率、生活质量、医疗费用和血液透析相关并发症。
获得了中国大连医科大学附属第一医院伦理委员会（注册号：YJ - KY - 2017 - 119）以及所有参与中心伦理委员会的伦理批准。ADIFE试验的最终结果将提交给研究赞助商、临床研究人员以及患者和公众参与参考小组。研究结果将通过同行评审期刊、临床实践指南以及在科学会议上进行传播。
ClinicalTrial.gov。注册号（NCT03385902）；预结果。
