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

14. Juli 2016 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48104
        • University Dialysis Unit
      • Livonia, Michigan, Vereinigte Staaten, 48152
        • University of Michigan Dialyisis Unit

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 85 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Sonstiges: 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).
Kein Eingriff: Control
Usual care in addition to Blood pressure monitoring and and Hydration status monitoring

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Blood Pressure
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Post-dialysis Weight
Zeitfenster: 12weeks
Change in target post-dialysis weight
12weeks
Heart Rate
Zeitfenster: 12 weeks
Change in heart rate
12 weeks
Plasma Volume
Zeitfenster: 12 Weeks
Slope of relative plasma volume monitoring
12 Weeks
Medication Use
Zeitfenster: 12 Weeks
Change in the utilization of antihypertensive medication ( number of medication and dose)
12 Weeks
Interdialytic Weight gain
Zeitfenster: 12 Weeks
Change in the mid-week interdialytic weight gain
12 Weeks
Intradialytic Hypotension
Zeitfenster: 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
Zeitfenster: Baseline, 6 week and 12 week
A measure of salt taste impairment and preference
Baseline, 6 week and 12 week
Thirst Score
Zeitfenster: Baseline, 6 week, 12 weeks
A measure of general thirst.
Baseline, 6 week, 12 weeks
Post-dialysis fatigue
Zeitfenster: Baseline, 6 Weeks & 12 Weeks
A measure of post-dialysis fatigue and recovery after each treatment session
Baseline, 6 Weeks & 12 Weeks
Routine Labs
Zeitfenster: 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
Zeitfenster: 12 weeks
Time to achievement of true 'dry weight' (in the intervention arm only)
12 weeks
Hydration Status
Zeitfenster: 12 weeks
Change in hydration status, as measured by BIA, using whole body and segmental techniques.
12 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Michigan

Mitarbeiter

Renal Research Institute

Ermittler

  • Hauptermittler: Rajiv Saran, MD, University of Michigan

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2012

Primärer Abschluss (Tatsächlich)

1. März 2016

Studienabschluss (Tatsächlich)

1. März 2016

Studienanmeldedaten

Zuerst eingereicht

9. Januar 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Januar 2013

Zuerst gepostet (Schätzen)

11. Januar 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

15. Juli 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Juli 2016

Zuletzt verifiziert

1. Juli 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HUM00054879

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