Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients
2 other identifiers
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2011
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 29, 2008
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2017
CompletedNovember 6, 2017
November 1, 2017
5.6 years
July 25, 2008
November 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ambulatory blood pressure
Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study
3 months
Secondary Outcomes (4)
thirst
3 months
QOL Scores (KDQOL, mins to recovery)
3 months
intradialytic hypotension rate, intradialytic symptoms
3 months
mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance
3 months
Study Arms (3)
1
OTHERstandard dialysate Na 140 mEq/L
2
ACTIVE COMPARATORdialysate sodium equal to patient's predialysis serum Na
3
ACTIVE COMPARATORdialysate sodium lower than patient's predialysis plasma sodium
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- frequent intradialytic hypotension
- estimated life expectancy \<1 year
- non-adherence to dialysis prescription
- pregnancy
- inability or unwillingness to complete study measures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Center
London, Ontario, N6A 4G5, Canada
Related Publications (1)
Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.
PMID: 39498822DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Rita Suri, MD, MSc
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 29, 2008
Study Start
November 1, 2011
Primary Completion
June 6, 2017
Study Completion
July 31, 2017
Last Updated
November 6, 2017
Record last verified: 2017-11