HypertensionNCT06547697
DIALYSATE SODIUM CONCENTRATION AND BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS
A study testing Dialysate sodium concentration in people with Hypertension, run by University Medical Centre Maribor.
Trial summary
While hypertension is one of the most common causes of end-stage renal disease, it is also present in the vast majority of hemodialysis patients. It is associated with higher cardiovascular morbidity and mortality in this group of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Dialysate sodium concentration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 1 Mar 2015
- Phase
- Interventional
- 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
- At least 18 years of age
- Patients with end-stage renal disease hemodialysis for at least 3 months
Who cannot join
- Non-cooperation
- Active cancer
- Hospitalization during the course of the study
About this study
Official title: EFFECT OF DIFFERENT DIALYSATE SODIUM CONCENTRATIONS ON BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS
While hypertension is one of the most common causes of end-stage renal disease, it is also present in the vast majority of hemodialysis patients. It is associated with higher cardiovascular morbidity and mortality in this group of patients. Altering dialysate sodium concentration presents a possibility of sodium balance control and blood pressure management. However, the ideal dialysate sodium concentration remains a topic for discussion.
Randomised and prospective single dialysis centre study is presented. The participants are randomly divided into 3 groups and will go through 3 periods of 2 months. A "low-to-high" dialysate sodium concentration group will start the study with 138 mmol/L in the first period, continue with 140 mmol/L in the second period and finish with 142 mmol/L. In the "high-to-low" group, the participants will go through the opposite design (reduction from 142 mmol/L to 138 mmol/L over 3 periods). One group will continue with 140 mmol/L throughout the study. Systolic and diastolic BP values before and after dialysis sessions, interdialytic weight gain, ultrafiltration, serum sodium concentration and the presence of hypotension between the groups in each period and within each group over all three periods will be evaluated.
- Conditions
- Hypertension
- Being tested
- Dialysate sodium concentration
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysate sodium concentrationOther
| Study group | Role | What they receive |
|---|---|---|
| Low-to-High | Experimental | In the first period, the participants will be receiving a dialysate sodium concentration of 138 mmol/L, in the second period 140 mmol/L and in the third period 142 mmol/L. Receives: Other: Dialysate sodium concentration |
| High-toLow | Experimental | In the first period, the participants will be receiving a dialysate sodium concentration of 142 mmol/L, in the second period 140 mmol/L and in the third period 138 mmol/L. Receives: Other: Dialysate sodium concentration |
| No change | Experimental | In all three periods the participants will be recieving the same dialysate sodium concentration of 140 mmol/L. Receives: Other: Dialysate sodium concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peridialytic blood pressure
Pre- and post dialysis blood pressure values
Measured: 6 months (3 periods of 2 months)
Secondary outcomes (3)
Interdialytic weight gain
Weight gain between dialysis sessions
Measured: 6 months (3 periods of 2 months)
Ultrafiltration
Change of needed ultrafiltration
Measured: 6 months (3 periods of 2 months)
Serum sodium concentration
Change of serum sodium due to the change of dialysate sodium
Measured: 6 months (3 periods of 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Sep 2014
- Primary completion1 Mar 2015
- Study completion1 Mar 2015
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 HypertensionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luka Varda, University Medical Centre Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547697
- Sponsor's protocol ID
- UMCMaribor
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Individual data sharing
- No
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 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF DIFFERENT DIALYSATE SODIUM CONCENTRATIONS ON BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS
- ClinicalTrials.gov ID
- NCT06547697
- Acronym / sponsor ID
- UMCMaribor
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Mar 2015 (actual)
- Study completion
- 1 Mar 2015 (actual)
- First posted
- 9 Aug 2024 (actual)
- 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.
While hypertension is one of the most common causes of end-stage renal disease, it is also present in the vast majority of hemodialysis patients. It is associated with higher cardiovascular morbidity and mortality in this group of patients. Altering dialysate sodium concentration presents a possibility of sodium balance control and blood pressure management. However, the ideal dialysate sodium concentration remains a topic for discussion.
Randomised and prospective single dialysis centre study is presented. The participants are randomly divided into 3 groups and will go through 3 periods of 2 months. A "low-to-high" dialysate sodium concentration group will start the study with 138 mmol/L in the first period, continue with 140 mmol/L in the second period and finish with 142 mmol/L. In the "high-to-low" group, the participants will go through the opposite design (reduction from 142 mmol/L to 138 mmol/L over 3 periods). One group will continue with 140 mmol/L throughout the study. Systolic and diastolic BP values before and after dialysis sessions, interdialytic weight gain, ultrafiltration, serum sodium concentration and the presence of hypotension between the groups in each period and within each group over all three periods will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-to-High | Experimental | Other: Dialysate sodium concentrationIn the first period, the participants will be receiving a dialysate sodium concentration of 138 mmol/L, in the second period 140 mmol/L and in the third period 142 mmol/L. |
| High-toLow | Experimental | Other: Dialysate sodium concentrationIn the first period, the participants will be receiving a dialysate sodium concentration of 142 mmol/L, in the second period 140 mmol/L and in the third period 138 mmol/L. |
| No change | Experimental | Other: Dialysate sodium concentrationIn all three periods the participants will be recieving the same dialysate sodium concentration of 140 mmol/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- Patients with end-stage renal disease hemodialysis for at least 3 months
Key exclusion criteria (3 listed)
- Non-cooperation
- Active cancer
- Hospitalization during the course of the study
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 |
|---|---|---|
| Dialysate sodium concentration | Other | High-toLow, Low-to-High, No change |
Primary outcome
Peridialytic blood pressure
Time frame: 6 months (3 periods of 2 months)
Pre- and post dialysis blood pressure values
3 secondary outcomes
Interdialytic weight gain
Time frame: 6 months (3 periods of 2 months)
Ultrafiltration
Time frame: 6 months (3 periods of 2 months)
Serum sodium concentration
Time frame: 6 months (3 periods of 2 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 14 Aug 2024.
- 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dialysate sodium concentration in people with Hypertension, run by University Medical Centre Maribor.
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 2 inclusion and 3 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 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Peridialytic blood pressure (time frame: 6 months (3 periods of 2 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 NCT06547697, 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 14 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.