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Dialysate Sodium Individualization in Hemodialysis

Primary Purpose

Hypertension, Hemodialysis Patients

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
dialysate sodium individualization
standard dialysate sodium
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, hemodialysis, sodium, dialysate, hemodynamics

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Davita New Haven Dialysis Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard dialysate sodium

dialysate sodium individualization

Arm Description

In the control phase of the study, the prescribed dialysate sodium is 140 mEq/L

.Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized").

Outcomes

Primary Outcome Measures

BP changes on 44-h ABPM
Changes in cardiac output and systemic vascular resistance
Changes in intracellular and extracellular volume

Secondary Outcome Measures

Changes in measured biochemical markers
Changes in augmentation index
Change in circadian BP profile on 44-h ABPM

Full Information

First Posted
November 28, 2005
Last Updated
July 21, 2016
Sponsor
Yale University
Collaborators
Satellite Research
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1. Study Identification

Unique Protocol Identification Number
NCT00259714
Brief Title
Dialysate Sodium Individualization in Hemodialysis
Official Title
Hemodynamic and Hormonal Responses to Dialysate Sodium Individualization in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Protocol was not feasible - only 1 of 18 enrollees completed procedures.
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Satellite Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hemodialysis Patients
Keywords
hypertension, hemodialysis, sodium, dialysate, hemodynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard dialysate sodium
Arm Type
Active Comparator
Arm Description
In the control phase of the study, the prescribed dialysate sodium is 140 mEq/L
Arm Title
dialysate sodium individualization
Arm Type
Experimental
Arm Description
.Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized").
Intervention Type
Drug
Intervention Name(s)
dialysate sodium individualization
Intervention Description
Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized").
Intervention Type
Drug
Intervention Name(s)
standard dialysate sodium
Intervention Description
The prescribed dialysate sodium is 140 mEq/L
Primary Outcome Measure Information:
Title
BP changes on 44-h ABPM
Time Frame
3 weeks
Title
Changes in cardiac output and systemic vascular resistance
Time Frame
3 weeks
Title
Changes in intracellular and extracellular volume
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Changes in measured biochemical markers
Time Frame
3 weeks
Title
Changes in augmentation index
Time Frame
3 weeks
Title
Change in circadian BP profile on 44-h ABPM
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldo J Peixoto, MD
Organizational Affiliation
Yale University and VA Connecticut Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Davita New Haven Dialysis Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15327422
Citation
de Paula FM, Peixoto AJ, Pinto LV, Dorigo D, Patricio PJ, Santos SF. Clinical consequences of an individualized dialysate sodium prescription in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1232-8. doi: 10.1111/j.1523-1755.2004.00876.x. Erratum In: Kidney Int. 2004 Nov;66(5):2108.
Results Reference
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Dialysate Sodium Individualization in Hemodialysis

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