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

This study is currently recruiting participants.
Verified January 2013 by University of Michigan
Sponsor:
Collaborator:
Renal Research Institute
Information provided by (Responsible Party):
Rajiv Saran, University of Michigan
ClinicalTrials.gov Identifier:
NCT01766882
First received: January 9, 2013
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
End Stage Renal Failure
 Behavioral: Lower sodium intervention
Other: Progressive Challenge to Post Dialysis Weight

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: Pre-dialysis BP measure at Basline, 6 Weeks and 12 weeks. ABPM measured at baseline and 12 Weeks. Home BP measure through out the 12week period on non-dialysis days ] [ Designated as safety issue: No ]
    Change in blood pressure (pre-dialysis in-center blood pressure readings, ABPM and home BP monitoring)


Secondary Outcome Measures:
  • Post-dialysis Weight [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
    Change in target post-dialysis weight

  • Heart Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in heart rate

  • Plasma Volume [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Slope of relative plasma volume monitoring

  • Medication Use [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Change inthe utilization of antihypertensive medication ( number of medication and dose)

  • Interdialytic Weight gain [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Change in the mid-week interdiyaltic weight gain

  • Intradialytic Hypotension [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    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.

  • Salt Appetite [ Time Frame: Baseline, 6 week and 12 week ] [ Designated as safety issue: No ]
    A measure of salt taste impairment and preference

  • Thirst Score [ Time Frame: Basline, 6 week, 12 weeks ] [ Designated as safety issue: No ]
    A measure of general thirst.

  • Post-dialysis fatigue [ Time Frame: Baseline, 6 Weeks & 12 Weeks ] [ Designated as safety issue: No ]
    A measure of post-dialysis fatigue and recovery after each treatment sesssion

  • Routine Labs [ Time Frame: Baseline and 12Week ] [ Designated as safety issue: No ]
    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 asymetric dimethyl arginine (ADMA), plasma aldosterone, and urinary neutrophil gelatinase-associated lipocalin (NGAL), respectively

  • True Dry Weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Time to achievement of true 'dry weight' (in the intervention arm only)

  • Hydration Status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in hydration status, as measured by BIA, using whole body and segmental techniques.


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 (approximatel >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

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 intradiaytic 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 incluion 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766882

Contacts
Contact: Linton Cuff 734-763-1612 lintoncu@med.umich.edu
Contact: Manilay Pulsinelli 734-763-4268 keomany@me.umich.edu

Locations
United States, Michigan
University Dialysis Unit Recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Linda Harju     734-677-4611     lharju@med.umich.edu    
University of Michigan Dialyisis Unit Not yet recruiting
Livonia, Michigan, United States, 48152
Contact: Therese Madamowski     734-432-7870     tadamows@med.umich.edu    
Sub-Investigator: Michael Heung, MD            
Sponsors and Collaborators
University of Michigan
Renal Research Institute
Investigators
Principal Investigator: Rajiv Saran, MD University of Michigan
  More Information

Publications:

Responsible Party: Rajiv Saran, Associate Professor, Internal Medicine/ Associate Director, Kidney Epidemiology & Cost Center, University of Michigan
ClinicalTrials.gov Identifier: NCT01766882     History of Changes
Other Study ID Numbers: HUM00054879
Study First Received: January 9, 2013
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Hemodialysis
Blood Pressure
Hydration Status
Low-sodium diet

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013