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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 50
- Locations
- 4
- Primary Endpoint
- Blood Pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Blood Pressure
Time Frame: 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
Change in blood pressure (pre-dialysis in-center blood pressure readings, ABPM and home BP monitoring)
Secondary Outcomes
- Salt Appetite(Baseline, 6 week and 12 week)
- Post-dialysis fatigue(Baseline, 6 Weeks & 12 Weeks)
- True Dry Weight(12 weeks)
- Thirst Score(Baseline, 6 week, 12 weeks)
- Post-dialysis Weight(12weeks)
- Heart Rate(12 weeks)
- Plasma Volume(12 Weeks)
- Interdialytic Weight gain(12 Weeks)
- Intradialytic Hypotension(12 Weeks)
- Medication Use(12 Weeks)
- Routine Labs(Baseline and 12Week)
- Hydration Status(12 weeks)
Investigators
Rajiv Saran
Associate Professor, Internal Medicine/ Associate Director, Kidney Epidemiology & Cost Center
University of Michigan