Volume,Sodium and Blood Pressure Management in HD
Fluid-Weight, Volume, Sodium, Blood Pressure Management in Hemodialysis by Limiting Intradialytic and Inter-dialytic Exposure to Sodium and Protocol-based Challenge of Post-dialysis Target Weight: A Pilot and Feasibility Trial
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.
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
End Stage Renal Failure
Hemodialysis, Blood Pressure, Hydration Status, Low-sodium diet
University of Michigan
University of Michigan, Renal Research Institute
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