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Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension

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ClinicalTrials.gov Identifier: NCT00237783
Recruitment Status : Terminated (Unable to recruit enough subjects)
First Posted : October 12, 2005
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hemodialysis Hypotension Drug: dialysate sodium (140 mmol/L) Drug: individualized dialysate sodium Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemodynamic Changes During Dialysate Sodium Individualization in Hemodialysis Patients
Study Start Date : October 2005
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: standard dialysate sodium (140 mmol/L)
dialysate sodium (140 mmol/L)
Drug: dialysate sodium (140 mmol/L)
Experimental: individualized dialysate sodium
individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)
Drug: individualized dialysate sodium
individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)


Outcome Measures

Primary Outcome Measures :
  1. Intradialytic BP change [ Time Frame: from study onset through intervention, week 7 ]

Secondary Outcome Measures :
  1. Intradialytic changes in cardiac output and peripheral vascular resistance [ Time Frame: from study onset through intervention, week 7 ]
  2. Interdialytic weight gain change [ Time Frame: from study onset through intervention, week 7 ]
  3. Thirst scores [ Time Frame: from study onset through intervention, week 7 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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: Yale University
ClinicalTrials.gov Identifier: NCT00237783     History of Changes
Other Study ID Numbers: AP0008
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by Yale University:
Renal dialysis
Hypotension
Dialysis solutions

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Dialysis Solutions
Pharmaceutical Solutions