Volume,Sodium and Blood Pressure Management in HD
Condition: End Stage Renal Failure
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The purpose of this study to conduct a pilot, randomized trial in stable HD patients to
      evaluate the effect of gradual, step-wise reduction of post-hemodialysis target weight,
      combined with diligent dietary sodium restriction and reduction in dialysate sodium exposure
      on hydration/volume status and blood pressure (BP) control.
    

Detailed description: 
      Fluid-weight management is critical for dialysis patients 1, 2. Previous clinical trials have
      not comprehensively addressed the application of a strategy combining both sodium restriction
      and a progressive, but gradual challenge of post dialysis target weight for BP and
      fluid-weight management in hemodialysis (HD). The investigators postulate that a
      protocolized, stepwise and gradual challenge of post-hemodialysis target weight when combined
      with diligent dietary sodium restriction <2000mg sodium/day, will lead to better
      hydration/volume status and BP control in HD patients. A randomized, two parallel arm trial
      (n=40) among HD patients is proposed, that compares this comprehensive strategy in one group
      versus 'usual' HD volume/hydration and BP management in the control group. The two primary
      outcomes are change in volume/hydration status (assessed by bioelectrical impedance
      analysis-BIA) and change in BP (pre-dialysis in-center readings, home self-monitored readings
      as well as 44-hour interdialytic BP). Secondary outcomes include change in target
      post-dialysis weight, slope of on-line relative plasma volume monitoring (using Crit-line
      monitors), utilization and change, if any, in antihypertensive regimen, change in
      interdialytic weight gain, objectively assessed salt-appetite, thirst score, frequency of
      intradialytic hypotension, cramps and duration of post-dialysis fatigue and recovery, time to
      achievement of dry weight and laboratory parameters (hemoglobin, albumin, brain natriuretic
      peptide-BNP, aldosterone and hsCRP). The trial will be 14-weeks in duration and will involve
      comprehensive assessment of study parameters at baseline, middle and end of the trial. It is
      anticipated that the trial will lead to the the development of a simple and practical
      approach for volume and BP control in HD patients that will subsequently need to be studied
      on a larger scale, i.e., a larger, multicenter study with hard endpoints of death and
      hospitalization.
    

Intervention name(s): Lower sodium intervention; Progressive Challenge to Post Dialysis Weight
Intervention type(s): Behavioral; Other
Intervention description(s): 1. Lower sodium intervention:
Dietary sodium restriction of ≤2.0 g/day or ≤85 mmol/day (approximately >180-200mmol/day in the average American diet). Sodium restriction will be implemented using intensive dietary counseling performed weekly by a registered study dietitian using the motivational interviewing technique.
Lower dialysate sodium at 137 mmol/L, if perchance a different concentration of dialysate is used for the enrolled individual, although this is unlikely in both the UM associated units, where for some time now, dialysate concentration of 137 mmol/L is currently being used as standard practice. Investigators will ensure that this sodium concentration is indeed used for all study participants.; The existing target post-HD weight will be progressively challenged by removing additional fluid in small increments, unless clinical evidence of volume depletion or hypotension precludes this challenge in the intervention arm. To avoid the occurrence of intradialytic hypotension, the ultrafiltration rate shall not exceed15 ml/kg/hour and post dialysis weight will not be reduced by more than 0.5 kg per dialysis session. In some patients, this may warrant prolongation of the treatment time to achieve lowering of target post dialysis weight, and this process of target weight reduction may need to continue up to and through the interim assessment phase (6-8 weeks).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hemodialysis; Blood Pressure; Hydration Status; Low-sodium diet