Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension

This study has been terminated.
(Unable to recruit enough subjects)
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00237783
First received: October 7, 2005
Last updated: October 3, 2008
Last verified: October 2008
  Purpose

Low blood pressure (hypotension) during dialysis afflicts approximately 25% of hemodialysis patients. In this pilot study, we will evaluate the safety and effects of individualizing the sodium concentration in the dialysate according to the patient's own plasma sodium levels. We hypothesize that patients will have less thirst and less weight gain during the intervention leading to easier fluid removal and less episodes of hypotension.


Condition Intervention
Hemodialysis
Hypotension
Drug: dialysate sodium concentration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hemodynamic Changes During Dialysate Sodium Individualization in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Intradialytic BP change

Secondary Outcome Measures:
  • Intradialytic changes in cardiac output and peripheral vascular resistance
  • Interdialytic weight gain change
  • Thirst scores

Estimated Enrollment: 7
Study Start Date: October 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Hypertension and intradialytic hypotension are common complications in patients on chronic maintenance hemodialysis (HD). Sodium balance is important in mediating both processes. Recent evidence 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 this project we plan to evaluate the safety and tolerability of sodium individualization in hypotension-prone patients in order to generate pilot data for a larger study in patients with intradialytic hypotension. In this protocol, we will recruit 7 hypotension-prone subjects. We will use an open-label 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 2 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 2 weeks (total study period 7 weeks, 2 weeks baseline, 4 weeks intervention). 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 hemodynamics (cardiac output and systemic vascular resistance), and the frequency and severity of intradialytic symptoms related to hypotension will be collected on HD sessions during the 4 weeks of intervention.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemodialysis patients with intradialytic hypotension

Exclusion Criteria:

  • Atrial fibrillation
  • Bilateral upper extremity arteriovenous access
  • Average plasma sodium >139
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00237783

Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Aldo J Peixoto, MD Yale University and VA Connecitcut Healthcare System
  More Information

Publications:
Responsible Party: Aldo Peixoto, MD, VA Connecticut
ClinicalTrials.gov Identifier: NCT00237783     History of Changes
Other Study ID Numbers: AP0008
Study First Received: October 7, 2005
Last Updated: October 3, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Renal dialysis
Hypotension
Dialysis solutions

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014