Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension
July 25, 2016 updated by: Yale University
Hemodynamic Changes During Dialysate Sodium Individualization in Hemodialysis Patients
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hemodialysis patients with intradialytic hypotension
Exclusion Criteria:
- Atrial fibrillation
- Bilateral upper extremity arteriovenous access
- Average plasma sodium >139
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: standard dialysate sodium (140 mmol/L)
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)
|
individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Intradialytic BP change
Time Frame: from study onset through intervention, week 7
|
from study onset through intervention, week 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Intradialytic changes in cardiac output and peripheral vascular resistance
Time Frame: from study onset through intervention, week 7
|
from study onset through intervention, week 7
|
|
Interdialytic weight gain change
Time Frame: from study onset through intervention, week 7
|
from study onset through intervention, week 7
|
|
Thirst scores
Time Frame: from study onset through intervention, week 7
|
from study onset through intervention, week 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aldo J Peixoto, MD, Yale University and VA Connecitcut Healthcare System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
October 7, 2005
First Submitted That Met QC Criteria
October 7, 2005
First Posted (Estimate)
October 12, 2005
Study Record Updates
Last Update Posted (Estimate)
July 26, 2016
Last Update Submitted That Met QC Criteria
July 25, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AP0008
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