Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients
Phase 3
Completed
- Conditions
- Hemodialysis
- Registration Number
- NCT00724633
- Lead Sponsor
- Lawson Health Research Institute
- Brief Summary
Patients currently receiving hemodialysis will be randomized to receive 1 of 3 dialysate sodium prescriptions. The effects on blood pressure, interdialytic weight gain, thirst, and intradialytic symptoms will be assessed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- patients on 3 times weekly hemodialysis of at least 3 months
- elevated average ambulatory blood pressures
- current dialysate sodium prescription 140mEq/L
- average pre-dialysis serum sodium <140mEq/L
Exclusion Criteria
- frequent intradialytic hypotension
- estimated life expectancy <1 year
- non-adherence to dialysis prescription
- pregnancy
- inability or unwillingness to complete study measures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Ambulatory blood pressure 3 months Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study
- Secondary Outcome Measures
Name Time Method intradialytic hypotension rate, intradialytic symptoms 3 months QOL Scores (KDQOL, mins to recovery) 3 months thirst 3 months mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance 3 months
Trial Locations
- Locations (1)
London Health Sciences Center
🇨🇦London, Ontario, Canada
London Health Sciences Center🇨🇦London, Ontario, Canada