HemodialysisPhase 3NCT00724633
Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients
A Phase 3 study testing Lowering the dialysate sodium in people with Hemodialysis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Lowering the dialysate sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2011to 31 Jul 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- frequent intradialytic hypotension
- estimated life expectancy <1 year
- non-adherence to dialysis prescription
- pregnancy
- inability or unwillingness to complete study measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients: a Randomized Controlled Trial.
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.
- Conditions
- Hemodialysis
- Being tested
- Lowering the dialysate sodium
- Keywords
- dialysate, sodium, hemodialysis, blood pressure, thirst, intradialytic symptoms, interdialytic weight gain, extracellular fluid balance, mechanisms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lowering the dialysate sodiumOther
Please see above
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | standard dialysate Na 140 mEq/L Receives: Other: Lowering the dialysate sodium |
| 2 | Active comparator | dialysate sodium equal to patient's predialysis serum Na Receives: Other: Lowering the dialysate sodium |
| 3 | Active comparator | dialysate sodium lower than patient's predialysis plasma sodium Receives: Other: Lowering the dialysate sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure
Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study
Measured: 3 months
Secondary outcomes (4)
thirst
Measured: 3 months
QOL Scores (KDQOL, mins to recovery)
Measured: 3 months
intradialytic hypotension rate, intradialytic symptoms
Measured: 3 months
mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study start1 Nov 2011
- Primary completion6 Jun 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita Suri, MD, MSc, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724633
- Sponsor's protocol ID
- R-08-252
- Other IDs
- 15153
- Status last verified
- Nov 2017
- First submitted
- 25 Jul 2008
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00724633
- Acronym / sponsor ID
- R-08-252
- Conditions
- Hemodialysis
- Keywords
- dialysate, sodium, hemodialysis, blood pressure, thirst, intradialytic symptoms, interdialytic weight gain, extracellular fluid balance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Lowering the dialysate sodiumstandard dialysate Na 140 mEq/L |
| 2 | Active comparator | Other: Lowering the dialysate sodiumdialysate sodium equal to patient's predialysis serum Na |
| 3 | Active comparator | Other: Lowering the dialysate sodiumdialysate sodium lower than patient's predialysis plasma sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- frequent intradialytic hypotension
- estimated life expectancy <1 year
- non-adherence to dialysis prescription
- pregnancy
- inability or unwillingness to complete study measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lowering the dialysate sodiumPlease see above | Other | 1, 2, 3 |
Primary outcome
Ambulatory blood pressure
Time frame: 3 months
Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study
4 secondary outcomes
thirst
Time frame: 3 months
QOL Scores (KDQOL, mins to recovery)
Time frame: 3 months
intradialytic hypotension rate, intradialytic symptoms
Time frame: 3 months
mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 39498822Marshall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Suri, MD, MSc principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lowering the dialysate sodium in people with Hemodialysis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory blood pressure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00724633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.