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Dialysate Sodium Individualization in Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259714
Recruitment Status : Terminated (Protocol was not feasible - only 1 of 18 enrollees completed procedures.)
First Posted : November 29, 2005
Last Update Posted : July 22, 2016
Satellite Research
Information provided by (Responsible Party):
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Hemodialysis Patients Drug: dialysate sodium individualization Drug: standard dialysate sodium Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hemodynamic and Hormonal Responses to Dialysate Sodium Individualization in Hemodialysis Patients
Study Start Date : March 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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").

Primary Outcome Measures :
  1. BP changes on 44-h ABPM [ Time Frame: 3 weeks ]
  2. Changes in cardiac output and systemic vascular resistance [ Time Frame: 3 weeks ]
  3. Changes in intracellular and extracellular volume [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Changes in measured biochemical markers [ Time Frame: 3 weeks ]
  2. Changes in augmentation index [ Time Frame: 3 weeks ]
  3. Change in circadian BP profile on 44-h ABPM [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259714

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United States, Connecticut
Davita New Haven Dialysis Unit
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Satellite Research
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Principal Investigator: Aldo J Peixoto, MD Yale University and VA Connecticut Healthcare System
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Responsible Party: Yale University Identifier: NCT00259714    
Other Study ID Numbers: 0509000646
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016
Keywords provided by Yale University:
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Dialysis Solutions
Pharmaceutical Solutions