高剂量血液透析滤过与高通量血液透析的利弊：高剂量血液透析滤过与高通量血液透析的比较（CONVINCE）试验方案。
Benefits and harms of high-dose haemodiafiltration versus high-flux haemodialysis: the comparison of high-dose haemodiafiltration with high-flux haemodialysis (CONVINCE) trial protocol.
机构信息
Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands
Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Center of Internal Medicine and Dermatology, Department of Psychosomatic Medicine, Berlin, Germany.
出版信息
BMJ Open. 2020 Feb 5;10(2):e033228. doi: 10.1136/bmjopen-2019-033228.
INTRODUCTION
End-stage kidney disease (ESKD) is a major public health problem affecting more than 2 million people worldwide. It is one of the most severe chronic non-communicable diseases. Haemodialysis (HD) is the most common therapeutic option but is also associated with a risk of cardiovascular events, hospitalisation and suboptimal quality of life. Over the past decades, haemodiafiltration (HDF) has become available. Although high-dose HDF has shown some promising survival advantage compared to conventional HD, the evidence remains controversial. A Cochrane systematic review found, in low-quality trials, with various convective forms of dialysis, a reduction in cardiovascular, but not all-cause mortality and the effects on non-fatal cardiovascular events and hospitalisation were uncertain. In contrast, an individual patient data analysis suggested that high-dose HDF reduced both all-cause and cardiovascular mortality compared to HD. In view of these discrepant results, a definitive trial is required to determine whether high-dose HDF is preferable to high-flux HD. The comparison of high-dose HDF with high-flux HD (CONVINCE) study will assess the benefits and harms of high-dose HDF versus a conventional high-flux HD in adults with ESKD.
METHODS AND ANALYSIS
This international, prospective, open label, randomised controlled trial aims to recruit 1800 ESKD adults treated with HD in nine European countries. Patients will be randomised 1:1 to high-dose HDF versus continuation of conventional high-flux HD. The primary outcome will be all-cause mortality at 3 years' follow-up. Secondary outcomes will include cause-specific mortality, cardiovascular events, all-cause and infection-related hospitalisations, patient-reported outcomes (eg, health-related quality of life) and cost-effectiveness.
ETHICS AND DISSEMINATION
The CONVINCE study will address the question of benefits and harms of high-dose HDF compared to high-flux HD for kidney replacement therapy in patients with ESKD with a focus on survival, patient perspectives and cost-effectiveness.
TRIAL REGISTRATION NUMBER
Netherlands National Trial Register (NTR 7138).
简介
终末期肾病（ESKD）是一个全球性的重大公共卫生问题，影响着全球超过 200 万人。它是最严重的慢性非传染性疾病之一。血液透析（HD）是最常见的治疗选择，但也存在心血管事件、住院和生活质量不佳的风险。在过去的几十年中，血液透析滤过（HDF）已经得到应用。虽然高剂量 HDF 与传统 HD 相比显示出一些有希望的生存优势，但证据仍然存在争议。一项 Cochrane 系统评价发现，在低质量试验中，使用各种对流形式的透析，可降低心血管死亡率，但不能降低全因死亡率，对非致死性心血管事件和住院的影响尚不确定。相比之下，一项个体患者数据分析表明，与 HD 相比，高剂量 HDF 降低了全因和心血管死亡率。鉴于这些相互矛盾的结果，需要进行一项确定性试验来确定高剂量 HDF 是否优于高通量 HD。高剂量 HDF 与高通量 HD 比较（CONVINCE）研究将评估在欧洲九个国家接受 HD 治疗的终末期肾病成人中，高剂量 HDF 与常规高通量 HD 的益处和危害。
方法和分析
这是一项国际性、前瞻性、开放标签、随机对照试验，旨在招募 1800 名在欧洲九个国家接受 HD 治疗的终末期肾病成人患者。患者将以 1:1 的比例随机分为高剂量 HDF 组和继续常规高通量 HD 组。主要结局是 3 年随访时的全因死亡率。次要结局将包括特定原因死亡率、心血管事件、全因和感染相关住院、患者报告的结局（如健康相关生活质量）和成本效益。
伦理和传播
CONVINCE 研究将解决与高剂量 HDF 相比，高通量 HD 对终末期肾病患者肾脏替代治疗的益处和危害问题，重点关注生存、患者观点和成本效益。
试验注册编号
荷兰国家试验注册处（NTR 7138）。
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