Clinical trial NCT02778516: Sodium-restricted Diets and Symptoms in End Stage Renal Disease: An RCT
Official title: Sodium-restricted Diets and Symptoms in End Stage Renal Disease: An RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ESRD
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2016-05-20
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Interdialytic Weight Gain
timeFrame: 5 days
measure: Palliative Care Outcomes Scale-Renal
timeFrame: 3-5 days
measure: Body Composition
timeFrame: 5 days
Secondary outcomes:
measure: Blood Pressure.
timeFrame: 5 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Nursing
state: Pennsylvania
Study officials:
References: