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临床试验/NCT02778516
NCT02778516已完成不适用

Sodium-restricted Diets and Symptoms in End Stage Renal Disease: An RCT

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Palliative Care Outcomes Scale-Renal

研究概览

简要总结

Dietary sodium intake independently increases the risk of mortality in end stage renal disease (ESRD). It plays a significant role in hypertension, hypervolemia, and left ventricular hypertrophy (LVH), and blunts the effectiveness of hypertensive agents. In addition, the hypervolemia associated with excessive dietary sodium intake results in the need for more intense fluid removal during dialysis (ultrafiltration), resulting in symptoms such as pain, cramps, hypotension, nausea, and vomiting during hemodialysis (HD) treatment sessions. Although sodium restriction is a universal recommendation for ESRD management, the National Kidney Foundation (NKF) recommendation of 2400 mg/day is consensus-based per the Dietary Approaches to Stop Hypertension (DASH) studies, not an evidence-based recommendation from data derived from a dialysis population. In addition, The Dietary Guidelines for Americans 2010, recommend further restriction of dietary sodium intake to 1500 mg per day for persons with hypertension and/or kidney disease, middle-aged and older adults, and African Americans, though there is also little empiric evidence to support this recommendation in the general population and none in the dialysis population. Therefore, it remains to be demonstrated that a diet with such sodium restrictions is attainable, sustainable, safe or beneficial. The investigators propose a double blind randomized controlled design investigation to examine the feasibility of assessing the effects of three levels of sodium intake (ambient, 2400 mg/d, 1500 mg/d) on the hemodialysis (HD) participant symptom profile, and to compare the effect of hemodialysis-specific variables on participant symptom profile during dialysis as well as to explore the role of body fluid composition using bioimpedance (BIA) measurements among the three sodium-restricted groups as a marker of sodium restriction efficacy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • persons ≥ 21 years of age
  • who have the ability to read and write,
  • who are undergoing maintenance HD
  • who are on therapy for at least 3 months.

排除标准

  • unable to read or write
  • non-English speaking
  • intend to move out of the area or change HD centers within 6 months
  • have terminal illness or life expectancy of less than 12 months,
  • plan to receive a living donor transplant in the study period, have cognitive impairment
  • are unable to provide informed consent
  • have heart Failure Class III or IV
  • have an internal defibrillator or pacemaker, and/or are pregnant.

结局指标

主要结局

Palliative Care Outcomes Scale-Renal

时间窗: 3-5 days

The POS is a survey used to measure health related QOL in the short term.68, 69 It reviews the symptoms listed in the KDQOL-36, however, the respondent refers to these symptoms in the short-term, the last three days

Interdialytic Weight Gain

时间窗: 5 days

IDWG is defined as the difference in weight in kilograms between measurement at time 1 (immediately following HD) and time 2 (immediately prior to the next HD session).4 Weights will be obtained in the aforementioned fashion in the CTRC, and calculated by the CTRC nursing core staff. The PI will train CTRC personnel on IDWG calculations.

Body Composition

时间窗: 5 days

Body composition will be measured with bioimpedance spectroscopy (BIS; ImpediMed® Imp_ SFB7, ImpediMed Limited, Queensland, Australia). Measurements include TBW, ECF, and ICF (in liters). We will take three consecutive measurements on the external surface of the skin by placing electrodes on the right hand and right foot. BIS has been shown good correlation with biochemical markers, such as the gold standard tracers methods (R2=0.93) when measuring ECF62, 63, but may have better clinical application due to its ease of use, reproducibility, and the fact that biochemical markers are costly and require vast amounts of training to perform, limiting the availability of analysis centers.

次要结局

  • Blood Pressure.(5 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maya N. Clark-Cutaia

Adjunct Faculty, Lecturer N

University of Pennsylvania

研究点 (2)

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