Volume,Sodium and Blood Pressure Management in HD (VSBP)

July 14, 2016 updated by: Rajiv Saran, University of Michigan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • University Dialysis Unit
      • Livonia, Michigan, United States, 48152
        • University of Michigan Dialyisis Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment

  1. Lower sodium intervention:

    Dietary sodium restriction of ≤2.0 g/day or ≤85 mmol/day

    Lower dialysate sodium at 137 mmol/L.

  2. Progressive Challenge to Post Dialysis Weight:

The existing target post-HD weight will be progressively challenged by removing additional fluid in small increments.
Behavioral: Lower sodium intervention

1. Lower sodium intervention:

  1. 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.
  2. 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.
Other: Progressive Challenge to Post Dialysis Weight
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).
No Intervention: Control
Usual care in addition to Blood pressure monitoring and and Hydration status monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-dialysis Weight
Time Frame: 12weeks
Change in target post-dialysis weight
12weeks
Heart Rate
Time Frame: 12 weeks
Change in heart rate
12 weeks
Plasma Volume
Time Frame: 12 Weeks
Slope of relative plasma volume monitoring
12 Weeks
Medication Use
Time Frame: 12 Weeks
Change in the utilization of antihypertensive medication ( number of medication and dose)
12 Weeks
Interdialytic Weight gain
Time Frame: 12 Weeks
Change in the mid-week interdialytic weight gain
12 Weeks
Intradialytic Hypotension
Time Frame: 12 Weeks
Frequency of intradialytic hypotension; defined as drop in systolic blood pressure associated with symptoms suggestive of low blood pressure such as lightheadedness, dizziness, sweating, etc., or decrease in intradialytic systolic blood pressure to less than 90 mmHg.
12 Weeks
Salt Appetite
Time Frame: Baseline, 6 week and 12 week
A measure of salt taste impairment and preference
Baseline, 6 week and 12 week
Thirst Score
Time Frame: Baseline, 6 week, 12 weeks
A measure of general thirst.
Baseline, 6 week, 12 weeks
Post-dialysis fatigue
Time Frame: Baseline, 6 Weeks & 12 Weeks
A measure of post-dialysis fatigue and recovery after each treatment session
Baseline, 6 Weeks & 12 Weeks
Routine Labs
Time Frame: Baseline and 12Week
o Routine labs including CBC, renal panel, hsCRP and brain natriuretic peptide (BNP). Interdialytic urine collection for residual renal function (urea and creatinine clearance) estimation will be made. Blood and urine samples will be archived for later analysis for biomarkers such as asymmetric dimethyl arginine (ADMA), plasma aldosterone, and urinary neutrophil gelatinase-associated lipocalin (NGAL), respectively
Baseline and 12Week
True Dry Weight
Time Frame: 12 weeks
Time to achievement of true 'dry weight' (in the intervention arm only)
12 weeks
Hydration Status
Time Frame: 12 weeks
Change in hydration status, as measured by BIA, using whole body and segmental techniques.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Renal Research Institute

Investigators

  • Principal Investigator: Rajiv Saran, MD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 9, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (Estimate)

January 11, 2013

Study Record Updates

Last Update Posted (Estimate)

July 15, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00054879

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Failure

Clinical Trials on Lower sodium intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe