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Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients

Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients: a Randomized Controlled Trial.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00724633
Enrollment
35
Registered
2008-07-29
Start date
2011-11-01
Completion date
2017-07-31
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis

Keywords

dialysate, sodium, hemodialysis, blood pressure, thirst, intradialytic symptoms, interdialytic weight gain, extracellular fluid balance, mechanisms

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.

Interventions

OTHERLowering the dialysate sodium

Please see above

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ambulatory blood pressure3 monthsAmbulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study

Secondary

MeasureTime frame
thirst3 months
QOL Scores (KDQOL, mins to recovery)3 months
intradialytic hypotension rate, intradialytic symptoms3 months
mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance3 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026