Dialysate Sodium Individualization in Hemodialysis

July 21, 2016 updated by: Yale University

Hemodynamic and Hormonal Responses to Dialysate Sodium Individualization in Hemodialysis Patients

Salt and water excess is an essential mechanism of hypertension. This is particularly relevant to patients with end stage kidney disease (ESKD) on dialysis. We have demonstrated that individualization of the sodium concentration in the dialysate as to match the patient's own serum sodium concentration leads to less thirst, interdialytic weight gain, and better BP control in hypertensive patients. In this study we will evaluate the mechanisms underlying this response by measuring systemic hemodynamics, body volume spaces, and biochemical marker of volume status.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Recent evidence from our group shows that individualization of the sodium concentration in the dialysate to match the patient's own serum sodium results in less thirst, less interdialytic weight gain, less HD-related symptoms, and better blood pressure control in hypertensive subjects. In this project we will evaluate the effect of dialysate sodium individualization on systemic hemodynamics, body volume compartments and biochemical markers of volume control in hypertensive hemodialysis patients. We will use a single-blind cross-over design with randomized blocks. After a 3-week baseline period where pre-HD serum sodium will be measured weekly to establish each patient's average serum sodium, subjects will be randomized to 3 weeks on standard dialysate sodium (140 mmol/L) or individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period), then crossed over to the other for another 3 weeks after a 1-week washout period (dialysate Na 140 mmol/L). The remainder of the dialysis prescription, prescribed dry weight and vasoactive drugs will remain unchanged throughout the study. Clinical information, pre/intra/post-HD blood pressure and thirst scores will be measured weekly at the mid-week dialysis session. In addition, we will measure systemic hemodynamics (cardiac output and systemic vascular resistance), bioimpedance measurements of intracellular and extracellular volume, arterial stiffness (aortic augmentation index, aortic pulse wave velocity), interdialytic (44h) ambulatory BP monitoring, and plasma BNP, renin, aldosterone and norepinephrine at baseline and at the end of each block.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

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
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Davita New Haven Dialysis 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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ESKD on hemodialysis
  • Hypertension, defined as average pre-HD BP >150/85 mmHg or use of antihypertensive drugs
  • Average pre-HD serum sodium <139 mmol/L

Exclusion Criteria:

  • Intradialytic hypotension
  • Atrial fibrillation or other chronic tachyarrhythmia (due to effects on measuring equipment)
  • Uncontrolled hypertension (average pre-HD BP >200/105 mmHg)
  • Uncontrolled diabetes mellitus (due to problems on interpretation of serum sodium values)
  • Debilitating illness
  • Inability to provide written informed consent

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard dialysate sodium
In the control phase of the study, the prescribed dialysate sodium is 140 mEq/L
Drug: standard dialysate sodium
The prescribed dialysate sodium is 140 mEq/L
Experimental: dialysate sodium individualization
.Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized").
Drug: dialysate sodium individualization
Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized").

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BP changes on 44-h ABPM
Time Frame: 3 weeks
3 weeks
Changes in cardiac output and systemic vascular resistance
Time Frame: 3 weeks
3 weeks
Changes in intracellular and extracellular volume
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in measured biochemical markers
Time Frame: 3 weeks
3 weeks
Changes in augmentation index
Time Frame: 3 weeks
3 weeks
Change in circadian BP profile on 44-h ABPM
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

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

Sponsor

Yale University

Collaborators

Satellite Research

Investigators

  • Principal Investigator: Aldo J Peixoto, MD, Yale University and VA Connecticut Healthcare System

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

March 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

November 28, 2005

First Submitted That Met QC Criteria

November 28, 2005

First Posted (Estimate)

November 29, 2005

Study Record Updates

Last Update Posted (Estimate)

July 22, 2016

Last Update Submitted That Met QC Criteria

July 21, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0509000646
  • 1034978.1.R06791..721688.02

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.

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