Liang Shuang, Wang Wen-Ling, Zhu Fang-Lei, Duan Shu-Wei, Sun Xue-Feng, Chen Xiang-Mei, Cai Guang-Yan
Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Disease., Beijing, China.
BMJ Open. 2018 Feb 24;8(2):e019457. doi: 10.1136/bmjopen-2017-019457.
The proportion of elderly people is steadily rising worldwide, especially in low-income and middle-income countries, including China. Chronic kidney disease (CKD) is a common disorder in older people. However, little is known about the epidemiology of CKD and its consequences among the elderly. Improvements on clinical guidelines and healthcare policies for this population are required. This study aims to examine the risk factors for progression of CKD among the elderly and develop models to identify subgroups who are at high risk.
This is a prospective, multicentre, cohort study. The study population comprises ~3000 patients with predialysis CKD, aged ≥65 years, recruited between March 2016 and December 2017. After the baseline assessments, these patients will be followed for 5 years or until the occurrence of primary outcomes. Assessments that include anthropomorphic measures, laboratory tests, questionnaires, and blood and urine specimen collection will be performed at baseline and at follow-ups. Data on demographic information, cognitive function, depression, risk of malnutrition, physical activity and quality of life will be collected. The primary outcomes are incidence of end-stage renal disease, loss of renal function (≥40% decline in glomerular filtration rate from baseline), and death. The secondary outcomes are acute coronary syndrome, hospitalisation for heart failure or unstable angina, cerebrovascular events, and peripheral arterial disease.
This study protocol has been approved by the ethics committees of the Chinese People's Liberation Army General Hospital and the participating centres. All the participants gave written informed consent before data collection. The findings of the study will be published in peer-reviewed journals and will be presented at national or international conferences.
NCT03246204; Pre-results.
全球老年人比例正在稳步上升，尤其是在包括中国在内的低收入和中等收入国家。慢性肾脏病（CKD）在老年人中是一种常见疾病。然而，关于CKD在老年人中的流行病学及其后果，我们知之甚少。需要改进针对这一人群的临床指南和医疗政策。本研究旨在探讨老年人CKD进展的危险因素，并建立模型以识别高危亚组。
这是一项前瞻性、多中心队列研究。研究人群包括2016年3月至2017年12月招募的约3000例年龄≥65岁的透析前CKD患者。在进行基线评估后，这些患者将被随访5年或直至出现主要结局。将在基线和随访时进行包括人体测量、实验室检查、问卷调查以及血液和尿液标本采集在内的评估。将收集有关人口统计学信息、认知功能、抑郁、营养不良风险、身体活动和生活质量的数据。主要结局为终末期肾病的发生率、肾功能丧失（肾小球滤过率较基线下降≥40%）和死亡。次要结局为急性冠状动脉综合征、因心力衰竭或不稳定型心绞痛住院、脑血管事件和外周动脉疾病。
本研究方案已获得中国人民解放军总医院及各参与中心伦理委员会的批准。所有参与者在数据收集前均签署了书面知情同意书。研究结果将发表在同行评审期刊上，并将在国内或国际会议上展示。
NCT03246204；预结果。
