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

终末期肾病的钠限制饮食和症状：随机对照试验

• 批准号: 8895418
• 负责人: Maya Nicole Clark-Cutaia
• 金额: $ 10.56万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8895418
• 关键词: Adult; Adverse effects; Age; American; Bioethics; Biological; Biological Markers; Body Composition; Body Water; Center for Translational Science Activities; Chronic Disease; Chronic Kidney Failure; Clinical Research; Consensus; Control Groups; Data; Data Analyses; Diet; Dietary Sodium; Disease Management; Double-Blind Method; Effectiveness; Electrolyte Balance; Electrolytes; End stage renal failure; Excision; Extracellular Fluid; Fluid Balance; Fluid overload; Foundations; Funding; Gender; General Population; Goals; Guidelines; Hemodialysis; Hour; Hypertension; Hypotension; Intake; Intervention; Intracellular Fluid; K-Series Research Career Programs; Kidney; Kidney Diseases; Lead; Left Ventricular Hypertrophy; Life; Link; Liquid substance; Measurement; Measures; Mechanics; Mentors; Methods; Modeling; Monitor; Muscle Cramp; Nausea and Vomiting; Nurses; Nutritional; Outcome; Outcome Study; Pain; Palliative Care; Participant; Patients; Pennsylvania; Persons; Physiological; Physiology; Play; Prevalence; Quality of life; Race; Randomized; Randomized Controlled Trials; Recommendation; Recruitment Activity; Reporting; Research; Research Training; Role; Safety; Science; Scientist; Series; Sodium; Sodium-Restricted Diet; Spectrum Analysis; Surveys; Symptoms; Testing; Training; Ultrafiltration; University Hospitals; Vulnerable Populations; Weight Gain; Work; base; biobehavior; burden of illness; career development; evidence based guidelines; experience; health disparity; illness length; mortality; nutrition; programs; public health relevance; responsible research conduct; secondary outcome; symptom management

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.

描述（由申请人提供）：膳食钠摄入可独立增加终末期肾病（ESRD）的死亡率。科学报告一致证明了钠限制对血液透析（HD）患者的益处，但对膳食钠摄入量的适当处方知之甚少。具体而言，缺乏 普遍实践建议的危害或益处的证据。拟议的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，血液透析治疗的生理学和力学以及身体成分;以及营养在ESRD管理中的作用;（2）终末期肾病患者的症状科学，症状管理的科学原理，以及症状与生理和营养变化的关系;（3）肾脏相关生理变量、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群体的生物伦理学以及该内容如何与负责任的研究行为（RCR）、数据/安全监测和随机对照试验（RCT）相关联。作为我职业发展的一部分，我将进行一项RCT，研究三种水平的钠摄入量（环境对照组[CG]，1500 mg/d [1.5G]，2400 mg/d [2.4G]）对ESRD患者HD症状特征的影响。这项拟议的研究将是第一个提供经验支持或反对目前的膳食钠摄入量建议的研究。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。具体目标是：1）证明三个钠摄入组之间的症状特征和透析间期体重增加（IDWG）不同对照组钠摄入量1.5G，钠摄入量2.4G，控制年龄、种族、性别、病程; 2）证明HD特异性变量[超滤率]（升/小时）和总液体清除量（升）]在三个钠摄入组之间的症状特征有所不同（CG，1.5G，2.4G），控制年龄、种族、性别和病程; 3）确定是否有全身水（TBW），细胞外液（ECF），在控制年龄、种族、性别和疾病持续时间的情况下，用生物阻抗谱（BIS）测量的细胞内和细胞内（ICF）的钠摄入量在钠摄入组（CG，1.5G，2.4G）之间变化。将从宾夕法尼亚大学医院肾脏、电解质和高血压科（肾脏组）招募42名成人受试者，并将在临床和转化研究中心的5天住院期间随机接受1/3种钠控制饮食。主要研究结局为IDWG和症状负担，采用姑息治疗结局量表-肾脏进行测量。次要结局包括TBW、ECF、ICF和HD特异性变量。将使用一系列多元回归模型来检验研究目标。