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

Completed · Not applicable

Conditions studied: ESRD

In brief

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.

Key facts

Study ID: NCT02778516
Run by: University of Pennsylvania
People needed: 42
Starts: 2014-08-01
Expected to finish: 2016-08-01
Last updated by the study team: 2017-06-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Pennsylvania School of Nursing — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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