Dialysate Sodium Individualization in Hemodialysis

This study has been terminated.
(Protocol was not feasible - only 1 of 18 enrollees completed procedures.)
Sponsor:
Collaborator:
Satellite Research
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00259714
First received: November 28, 2005
Last updated: October 3, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Hypertension
Hemodialysis Patients
Drug: dialysate sodium individualization
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Hemodynamic and Hormonal Responses to Dialysate Sodium Individualization in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • BP changes on 44-h ABPM [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Changes in cardiac output and systemic vascular resistance [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Changes in intracellular and extracellular volume [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in measured biochemical markers [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Changes in augmentation index [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Change in circadian BP profile on 44-h ABPM [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: March 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: dialysate sodium individualization
    Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized"). In the control phase of the study, the prescribed dialysate sodium is 140 mEq/L.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259714

Locations
United States, Connecticut
Davita New Haven Dialysis Unit
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Satellite Research
Investigators
Principal Investigator: Aldo J Peixoto, MD Yale University and VA Connecticut Healthcare System
  More Information

Publications:
Responsible Party: Aldo J. Peixoto, MD, Yale University
ClinicalTrials.gov Identifier: NCT00259714     History of Changes
Other Study ID Numbers: 0509000646, 1034978.1.R06791..721688.02
Study First Received: November 28, 2005
Last Updated: October 3, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
hypertension
hemodialysis
sodium
dialysate
hemodynamics

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Dialysis Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014