Clinical trial NCT01766882: Volume,Sodium and Blood Pressure Management in HD
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Failure
Keywords: Hemodialysis
Blood Pressure
Hydration Status
Low-sodium diet
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Renal Research Institute
First posted: 2013-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Pressure
timeFrame: Pre-dialysis BP measure at Baseline, 6 Weeks and 12 weeks. ABPM measured at baseline and 12 Weeks. Home BP measure through out the 12week period on non-dialysis days
Secondary outcomes:
measure: Post-dialysis Weight
timeFrame: 12weeks
measure: Heart Rate
timeFrame: 12 weeks
measure: Plasma Volume
timeFrame: 12 Weeks
measure: Medication Use
timeFrame: 12 Weeks
measure: Interdialytic Weight gain
timeFrame: 12 Weeks
measure: Intradialytic Hypotension
timeFrame: 12 Weeks
measure: Salt Appetite
timeFrame: Baseline, 6 week and 12 week
measure: Thirst Score
timeFrame: Baseline, 6 week, 12 weeks
measure: Post-dialysis fatigue
timeFrame: Baseline, 6 Weeks & 12 Weeks
measure: Routine Labs
timeFrame: Baseline and 12Week
measure: True Dry Weight
timeFrame: 12 weeks
measure: Hydration Status
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University Dialysis Unit
state: Michigan
city: Livonia
country: United States
facility: University of Michigan Dialyisis Unit
state: Michigan
Study officials:
affiliation: University of Michigan
name: Rajiv Saran, MD
role: PRINCIPAL_INVESTIGATOR
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