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

NCT02778516 | Completed DMC

• 1 other identifier: 819779
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

ESRD

Outcome Measures

Primary Outcomes (3)

• Interdialytic Weight Gain

  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.

  5 days

• Palliative Care Outcomes Scale-Renal

  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

  3-5 days

• Body Composition

  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.

  5 days

Secondary Outcomes (1)

• Blood Pressure.

  5 days

Study Arms (3)

Sodium Restriction 1500mg Group

ACTIVE COMPARATOR

During the intervention phase of the study, participants will consume iso-caloric diets provided by the CTRC Nutrition Services Metabolic Kitchen at the UPHS. Diets will differ only in sodium content. To ensure accurate calculation of calorie and dietary sodium content for each individual, sodium content from all uneaten foods will be deducted from total daily dietary sodium intake. Total sodium intake will be calculated by CTRC Nutrition Staff and recorded on the data collection sheet after each meal and used in final analyses.

Dietary Supplement: Sodium Restriction

Sodium Restriction 2400mg Group

ACTIVE COMPARATOR

During the intervention phase of the study, participants will consume iso-caloric diets provided by the CTRC Nutrition Services Metabolic Kitchen at the UPHS. Diets will differ only in sodium content. To ensure accurate calculation of calorie and dietary sodium content for each individual, sodium content from all uneaten foods will be deducted from total daily dietary sodium intake. Total sodium intake will be calculated by CTRC Nutrition Staff and recorded on the data collection sheet after each meal and used in final analyses.

Dietary Supplement: Sodium Restriction

Control Group

NO INTERVENTION

During the intervention phase of the study, participants will consume iso-caloric diets provided by the CTRC Nutrition Services Metabolic Kitchen at the UPHS. Diets will differ only in sodium content. To ensure accurate calculation of calorie and dietary sodium content for each individual, sodium content from all uneaten foods will be deducted from total daily dietary sodium intake. Total sodium intake will be calculated by CTRC Nutrition Staff and recorded on the data collection sheet after each meal and used in final analyses.

Interventions

Sodium Restriction DIETARY_SUPPLEMENT

Sodium Restriction 1500mg Group; Sodium Restriction 2400mg Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Pennsylvania School of Nursing

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Faculty, Lecturer N

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: May 20, 2016
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 15, 2017

Record last verified: 2017-06

Locations

US (1)