Design of a randomized controlled clinical trial assessing dietary sodium restriction and hemodialysis-related symptom profiles

AimIn hemodialysis patients, the need to have intercurrent sodium and water intake removed by ultrafiltration increases disease burden through the symptoms and signs that occur during hemodialysis (HD). This added burden may be mitigated by reduction of dietary sodium intake. The National Kidney Foundation (NKF) recommends 2400 mg of dietary sodium daily for patients on HD, and the American Heart Association (AHA) suggests 1500 mg, evidence is lacking, however, to support these recommendations in HD. Moreover, little is known about the relationship of specific levels of dietary sodium intake and the severity of symptoms and signs during ultrafiltration. Our goal will be to determine the effects of carefully-monitored levels of sodium-intake as set forth by the NKF and AHA on symptoms and signs in patients undergoing (HD).MethodsWe designed a three-group (2400 mg, 1500 mg, unrestricted), double blinded randomized controlled trial with a sample of 42 HD participants to determine whether 1. Symptom profiles and interdialytic weight gains vary among three sodium intake groups; 2. The effect of HD-specific variables on the symptom profiles among the three groups and 3. Whether total body water extracellular volume and intracellular volume measured with bioimpedance varies across the three groups. We will also examine the feasibility of recruitment, enrollment, and retention of participants for the five-day inpatient stay.ConclusionCurbing dietary sodium intake may lead to improvement in intradialytic symptom amelioration and potential for better long-term outcomes. Generating empirical support will be critical to ascertain, and espouse, the appropriate level of sodium intake for patients receiving HD.