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CompletedNCT00724633Updated Nov 6, 2017

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

A Phase 3 interventional study of Lowering the dialysate sodium in Hemodialysis, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-06.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hemodialysis

Keywords

  • dialysate
  • sodium
  • hemodialysis
  • blood pressure
  • thirst
  • intradialytic symptoms
  • interdialytic weight gain
  • extracellular fluid balance
  • mechanisms
03

In context

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 327 studies on the registry; 132 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • frequent intradialytic hypotension
  • estimated life expectancy \<1 year
  • non-adherence to dialysis prescription
  • pregnancy
  • inability or unwillingness to complete study measures
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • Other
    1

    standard dialysate Na 140 mEq/L

    Other: Lowering the dialysate sodium

  • Active comparator
    2

    dialysate sodium equal to patient's predialysis serum Na

    Other: Lowering the dialysate sodium

  • Active comparator
    3

    dialysate sodium lower than patient's predialysis plasma sodium

    Other: Lowering the dialysate sodium

Interventions

  • OtherLowering the dialysate sodium

    Please see above

06

What researchers measure

Primary outcomes

  1. Ambulatory blood pressure

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

    Time frame: 3 months

Secondary outcomes

  1. thirst

    Time frame: 3 months

  2. QOL Scores (KDQOL, mins to recovery)

    Time frame: 3 months

  3. intradialytic hypotension rate, intradialytic symptoms

    Time frame: 3 months

  4. mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance

    Time frame: 3 months

07

Study locations

1 site
  • London Health Sciences Center
    London, Ontario N6A 4G5, Canada
08

References and documents

Publications

  • 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. PubMed 39498822 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00724633
Responsible party
Sponsor
First posted
Jul 29, 2008
Start date
Nov 1, 2011
Primary completion
Jun 6, 2017
Completion
Jul 31, 2017
Last update
Nov 6, 2017

Study contacts

Rita Suri, MD, MSc
principal investigator · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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