Sodium-restricted diets and symptoms in end stage renal disease: An RCT

描述(由申请人提供)：膳食钠摄入量独立增加终末期肾病(ESRD)的死亡率。在血液透析(HD)患者中，钠限制的益处一直在科学报告中得到证实，尽管人们对饮食钠摄入量的适当处方知之甚少。具体地说，缺乏 普遍实施的建议的危害或益处的证据。NINR职业发展奖的总体目标是接受以下方面的高级研究培训：(1)肾脏生理学，包括液体和电解质平衡，HD治疗的生理和力学以及身体成分；以及营养在终末期肾病治疗中的作用；(2)终末期肾病患者的症状科学，症状管理的科学理论，以及症状与生理和营养变化的关系；(3)与肾脏相关的生理变量、生物标志物和患者症状的方法和测量策略；(4)重复测量，生理变量的纵向数据分析；(5)研究患有慢性病的弱势人群的生物伦理学及其内容与负责任的研究(RCR)、数据/安全监测和随机对照试验(RCT)的关系。作为我职业发展的一部分，我将进行一项随机对照试验，以研究三种钠摄入量水平(环境对照组、1500 mg/d[1.5g]、2400 mg/d[2.4g])对终末期肾病患者HD症状的影响。这项拟议的研究将是此类研究中第一个对当前膳食钠摄入量建议提供经验支持或反对的研究。这项研究将为收集正确识别适当的饮食钠限制处方所需的基本证据提供第一步。具体目的是：1)证明三个钠摄入量组(CG，钠摄入量1.5g，钠摄入量2.4g)之间的症状谱和透析间体重增加(IDWG)不同，控制年龄、种族、性别和病程；2)证明HD特异性变量[超滤率(L/小时)和总液体清除量(L)]对症状谱的影响在三个钠摄入量组(CG、1.5G、2.4G)之间不同，控制年龄、种族、性别和病程；3)在控制年龄、种族、性别和病程的情况下，确定生物阻抗谱(BIS)测量的全身水分(TBW)、细胞外液(ECF)和细胞内液体(ICF)在不同钠摄入量组(CG、1.5G、2.4G)之间是否存在差异。42名成年参与者将从宾夕法尼亚大学医院肾脏、电解质和高血压科(肾病组)招募，并将在临床和翻译研究中心停留5天期间随机接受1-3种钠控制饮食。主要的研究结果是IDWG和症状负担，用姑息治疗结果量表-肾脏来衡量。次要结果包括TBW、ECF、ICF和HD特有变量。将使用一系列多元回归模型来检验研究目标。

DESCRIPTION (provided by applicant): Dietary sodium intake independently increases mortality in end-stage renal disease (ESRD). The benefits of sodium restriction in patients undergoing hemodialysis (HD) are consistently demonstrated in scientific reports, though little is known about the appropriate prescription of dietary sodium intake. Specifically, there is a lack of evidence of either harm or benefit of universal practiced recommendations. The overall objective of the proposed NINR Career Development Award is to receive advanced research training in: (1) Renal physiology including fluid and electrolyte balance, the physiology and mechanics of HD therapy and body composition; and the role of nutrition in management of ESRD; (2) Symptom science in patients with ESRD, the scientific rationale for symptom management, and how symptoms are related to physiological and nutritional changes; (3) Methods and measurement strategies of renal-related physiological variables, biological markers, and patient symptoms; (4) Repeated measures, longitudinal data analysis of physiologic variables; (5) Bioethics of studying vulnerable populations with chronic illness and how that content relates to the responsible conduct of research (RCR), and data/safety monitoring and randomized controlled trials (RCT). As part of my career development, I will conduct an RCT to study the effects of three levels of sodium intake (ambient control group [CG], 1500 mg/d [1.5G], 2400 mg/d [2.4G]) on the HD symptom profile of ESRD patients. The proposed study will be the first of its kind to offer empiric support for or against the current dietary sodium intake recommendations. The study will provide the first step to gathering essential evidence needed to correctly identify the appropriate dietary sodium restriction prescription. The specific aims are to: 1) demonstrate that symptom profiles and interdialytic weight gain (IDWG) vary among three sodium intake groups (CG, sodium intake of 1.5G, sodium intake of 2.4G), controlling for age, race, gender, and duration of disease; 2) demonstrate that the effect of HD-specific variables [ultrafiltration rate (liters/hour) and total luid removed (liters)] on the symptom profiles vary among the three sodium intake groups (CG, 1.5G, 2.4G), controlling for age, race, gender, and duration of disease; 3) determine whether total body water (TBW), extracellular fluid (ECF), and intracellular (ICF) measured with bioimpedance spectroscopy (BIS) varies across sodium intake groups (CG, 1.5G, 2.4G), controlling for age, race, gender, and duration of disease. Forty-two adult participants will be recruited from the Hospital of the University of Pennsylvania Renal, Electrolyte, and Hypertension Division (Renal Group) and will be randomized to one three sodium-controlled diets during a 5- day stay in the Clinical and Translational Research Center. The primary study outcomes are IDWG and symptom burden as measured with the Palliative Care Outcome Scale-Renal. Secondary outcomes include TBW, ECF, ICF, and HD-specific variables. A series of multiple regression models will be used to test the study aims.