降低盐摄入量对减少慢性肾脏病患者心血管风险的影响（LowSALT CKD 研究）：一项随机试验的方案。
The effect of lowering salt intake on ambulatory blood pressure to reduce cardiovascular risk in chronic kidney disease (LowSALT CKD study): protocol of a randomized trial.
机构信息
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, Brisbane, QLD, 4102, Australia.
出版信息
BMC Nephrol. 2012 Oct 19;13:137. doi: 10.1186/1471-2369-13-137.
BACKGROUND
Despite evidence implicating dietary sodium in the pathogenesis of cardiovascular disease (CVD) in chronic kidney disease (CKD), quality intervention trials in CKD patients are lacking. This study aims to investigate the effect of reducing sodium intake on blood pressure, risk factors for progression of CKD and other cardiovascular risk factors in CKD.
METHODS/DESIGN: The LowSALT CKD study is a six week randomized-crossover trial assessing the effect of a moderate (180 mmol/day) compared with a low (60 mmol/day) sodium intake on cardiovascular risk factors and risk factors for kidney function decline in mild-moderate CKD (stage III-IV). The primary outcome of interest is 24-hour ambulatory blood pressure, with secondary outcomes including arterial stiffness (pulse wave velocity), proteinuria and fluid status. The randomized crossover trial (Phase 1) is supported by an ancillary trial (Phase 2) of longitudinal-observational design to assess the longer term effectiveness of sodium restriction. Phase 2 will continue measurement of outcomes as per Phase 1, with the addition of patient-centered outcomes, such as dietary adherence to sodium restriction (degree of adherence and barriers/enablers), quality of life and taste assessment.
DISCUSSION
The LowSALT CKD study is an investigator-initiated study specifically designed to assess the proof-of-concept and efficacy of sodium restriction in patients with established CKD. Phase 2 will assess the longer term effectiveness of sodium restriction in the same participants, enhancing the translation of Phase 1 results into practice. This trial will provide much-needed insight into sodium restriction as a treatment option to reduce risk of CVD and CKD progression in CKD patients.
TRIAL REGISTRATION
Universal Trial Number: U1111-1125-2149. Australian New Zealand Clinical Trials Registry Number: ACTRN12611001097932.
背景
尽管有证据表明膳食钠在慢性肾脏病（CKD）患者心血管疾病（CVD）发病机制中的作用，但缺乏针对 CKD 患者的高质量干预试验。本研究旨在探讨减少钠摄入量对 CKD 患者血压、CKD 进展风险因素和其他心血管风险因素的影响。
方法/设计：低盐 CKD 研究是一项为期六周的随机交叉试验，评估中等（180mmol/天）与低（60mmol/天）钠摄入量对轻度至中度 CKD（III-IV 期）心血管风险因素和肾功能下降风险因素的影响。主要研究终点为 24 小时动态血压，次要终点包括动脉僵硬（脉搏波速度）、蛋白尿和液体状态。随机交叉试验（第 1 阶段）由纵向观察设计的辅助试验（第 2 阶段）支持，以评估钠限制的长期有效性。第 2 阶段将继续按照第 1 阶段测量结果，同时增加以患者为中心的结果，如钠限制的饮食依从性（依从程度和障碍/促进因素）、生活质量和味觉评估。
讨论
低盐 CKD 研究是一项由研究者发起的研究，专门用于评估在已确诊的 CKD 患者中限制钠摄入的概念验证和疗效。第 2 阶段将在同一参与者中评估钠限制的长期有效性，从而将第 1 阶段的结果更有效地转化为实践。该试验将为钠限制作为降低 CKD 患者 CVD 和 CKD 进展风险的治疗选择提供急需的见解。
试验注册
通用试验编号：U1111-1125-2149。澳大利亚新西兰临床试验注册编号：ACTRN12611001097932。
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