Volume,Sodium and Blood Pressure Management in HD

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.

Inclusion Criteria:

- Stable adult HD patient (age 18-85 years)

- Usual in-center pre-dialysis systolic blood pressure of ≥130mmHg. For this purpose
mean of pre-dialysis sitting blood pressures for the past one month prior to
randomization will be applied for evaluation of inclusion criteria.

- Able and willing to adhere to study protocol

Exclusion Criteria:

- Recent acute illness (≤1month)

- Recent hospitalization (≤1month)

- Any psychological condition that could interfere with compliance with study protocol.

- Amputation of both lower limbs (due to interference with electric current for BIA
measurement)

- Pacemaker, defibrillator, implantable pump, artificial joint, pins, plates or other
types of metal objects in the body (other than dental fillings), if their presence
interfere with appropriate measurements. In such patients consideration will be given
to only doing the calf-BIA measurements and not the total body, at the discretion of
the investigators.

- Use of any investigational product or device within 30 days prior to screening, or
requirement for any investigational agent prior to completion of all scheduled study
assessments.

- Pregnancy or lactation (pregnancy test will be applied only if the patient is in the
reproductive age range).

- Any condition that, in the view of the PI, places the subject at high risk of poor
treatment compliance or of not completing the study