Hemodialysis PatientsNCT05169125
Reducing Dialysate Sodium Effect on Blood Pressure Variability in Hemodialysis Patients
A study testing standard hemodialysis and lower dialysate sodium dialysis in people with Hemodialysis Patients, run by Mansoura University.
Trial summary
In this study the investigators aim to test the effect of lowering dialysate sodium concentration on visit-to-visit blood pressure variability in hemodialysis patients who have achieved their dry weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- standard hemodialysis and lower dialysate sodium dialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Jul 2022
- 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
- Patients' age ≥18 years
- Patients who had been on regular hemodialysis for at least 3 months.
- Patients' residual daily urine output is less than 100 mL/day.
- Pre study one week average systolic BP ≥120 mmHg but ≤ 180 mmHg.
- Patients who have achieved their dry weight as assessed by clinical examination.
- Predialytic serum sodium level ≥ 140mmol/l.
- Kt/V ≥ 1.2
Who cannot join
- Patients who have advanced heart failure or permanent atrial fibrillation decompensated liver disease, neoplastic illness, overt edema.
- History of acute cardiovascular accidents or infections during 3 months preceding entry into the study.
- Patients prone to hypotension or other intradialytic adverse events.
- Patients participating in another interventional study that may affect blood pressure.
Trial locations and contacts
No sites are listed yet.
Hoda Abdulaziz, Lecturer contact
About this study
Official title: Effect of Reducing Dialysate Sodium Concentration on Blood Pressure Variability in Hemodialysis Patients: A Randomized Controlled Trial
In this study the investigators aim to test the effect of lowering dialysate sodium concentration on visit-to-visit blood pressure variability in hemodialysis patients who have achieved their dry weight.
Read the detailed description
Cardiovascular diseases are considered the major cause of mortality in maintenance hemodialysis patients. Nevertheless, hypertension is recognized as an important modifiable risk factor for cardiovascular disease among hemodialysis (HD) patients.
Apart from blood pressure levels, BP variability, which reflects the fluctuation in BP, has been described as an independent risk factor that linearly associated with all-cause and cardiovascular mortality in HD patients.
BPV is categorized as either long or short term, based on the time interval over which it is considered. In the dialysis population, long-term BPV is typically defined on the basis of BP measurements taken at the start of each thrice-weekly hemodialysis treatment (interdialytic BPV). On the other hand, short-term BPV among dialysis patients can be considered in terms of variability that occurs during hemodialysis treatments (intradialytic BPV). Researchers believed that the mitigation strategies of BPV must be paid attention to.
Sodium load is associated with thirst, fluid retention, interdialysis weight gain and hypertension for hemodialysis patients, therefore the Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guideline highlighted the importance of limiting sodium intake and adequate sodium removal which is considered one of the most important goals of the dialysis therapy.
Interestingly, a recent study showed that mild decrease in dialysate sodium concentration could improve systolic blood pressure variability in HD patients at their dry weight, thus improving blood pressure complications and subsequent complications. However, whether improving sodium balance could potentially contribute to better BPV management in HD patients has not been assessed in a randomized manner. Therefore, this study aims to investigate whether lowering dialysate sodium concentration could help mitigate long term (interdialytic) BPV in hemodialysis patients in a randomized controlled manner.
- Conditions
- Hemodialysis Patients
- Being tested
- standard hemodialysis, lower dialysate sodium dialysis
- Keywords
- sodium, variability, hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard hemodialysisProcedure or surgery
patients who will undergo standard hemodialysis (dialysate sodium concentration 143 mmoL/L)
lower dialysate sodium dialysisProcedure or surgery
patients who will undergo hemodialysis with lower dialysate sodium concentration (140 mmoL/L)
| Study group | Role | What they receive |
|---|---|---|
| Group A: standard hemodialysis. | Active comparator | patients who will undergo standard hemodialysis (dialysate sodium concentration 143 mmoL/L) Receives: Procedure: standard hemodialysis |
| Group B: lower dialysate sodium hemodialysis. | Active comparator | patients who will undergo hemodialysis with lower dialysate sodium concentration (140 mmoL/L). Receives: Procedure: lower dialysate sodium dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure variability.
visit to visit blood pressure variability in both groups.
Measured: 2 weeks after the study duration (3 months).
Secondary outcomes (3)
interdialytic weight gain
interdialytic weight gain
Measured: 2 weeks after the study duration (3 months).
antihypertensive medication regimen
antihypertensive medication regimen
Measured: 2 weeks after the study duration (3 months).
the frequency of intradialytic adverse events
the frequency of intradialytic adverse events as hypotensive crises and cramps.
Measured: 2 weeks after the study duration (3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Tarek Abdelaziz Gomaa, Mansoura University
- Investigators
- Ghada El-said, Ass. Prof., Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169125
- Sponsor's protocol ID
- MS.21.06.1547
- Status last verified
- Dec 2021
- First submitted
- 10 Nov 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdulaziz HMM, Gomaa H, El-Said G. Improvement of visit-to-visit SBP variability with lowering dialysate sodium concentration in patients undergoing hemodialysis: a randomized controlled trial. J Hypertens. 2026 Apr 1;44(4):629-635. doi: 10.1097/HJH.0000000000004243. Epub 2026 Jan 22.
PubMed 41649081Marshall 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 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reducing Dialysate Sodium Concentration on Blood Pressure Variability in Hemodialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05169125
- Acronym / sponsor ID
- MS.21.06.1547
- Conditions
- Hemodialysis Patients
- Keywords
- sodium, variability, hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 23 Dec 2021 (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.
In this study the investigators aim to test the effect of lowering dialysate sodium concentration on visit-to-visit blood pressure variability in hemodialysis patients who have achieved their dry weight.
Detailed description
Cardiovascular diseases are considered the major cause of mortality in maintenance hemodialysis patients. Nevertheless, hypertension is recognized as an important modifiable risk factor for cardiovascular disease among hemodialysis (HD) patients.
Apart from blood pressure levels, BP variability, which reflects the fluctuation in BP, has been described as an independent risk factor that linearly associated with all-cause and cardiovascular mortality in HD patients.
BPV is categorized as either long or short term, based on the time interval over which it is considered. In the dialysis population, long-term BPV is typically defined on the basis of BP measurements taken at the start of each thrice-weekly hemodialysis treatment (interdialytic BPV). On the other hand, short-term BPV among dialysis patients can be considered in terms of variability that occurs during hemodialysis treatments (intradialytic BPV). Researchers believed that the mitigation strategies of BPV must be paid attention to.
Sodium load is associated with thirst, fluid retention, interdialysis weight gain and hypertension for hemodialysis patients, therefore the Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guideline highlighted the importance of limiting sodium intake and adequate sodium removal which is considered one of the most important goals of the dialysis therapy.
Interestingly, a recent study showed that mild decrease in dialysate sodium concentration could improve systolic blood pressure variability in HD patients at their dry weight, thus improving blood pressure complications and subsequent complications. However, whether improving sodium balance could potentially contribute to better BPV management in HD patients has not been assessed in a randomized manner. Therefore, this study aims to investigate whether lowering dialysate sodium concentration could help mitigate long term (interdialytic) BPV in hemodialysis patients in a randomized controlled manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: standard hemodialysis. | Active comparator | Procedure: standard hemodialysispatients who will undergo standard hemodialysis (dialysate sodium concentration 143 mmoL/L) |
| Group B: lower dialysate sodium hemodialysis. | Active comparator | Procedure: lower dialysate sodium dialysispatients who will undergo hemodialysis with lower dialysate sodium concentration (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 (7 listed)
- Patients' age ≥18 years
- Patients who had been on regular hemodialysis for at least 3 months.
- Patients' residual daily urine output is less than 100 mL/day.
- Pre study one week average systolic BP ≥120 mmHg but ≤ 180 mmHg.
- Patients who have achieved their dry weight as assessed by clinical examination.
Key exclusion criteria (4 listed)
- Patients who have advanced heart failure or permanent atrial fibrillation decompensated liver disease, neoplastic illness, overt edema.
- History of acute cardiovascular accidents or infections during 3 months preceding entry into the study.
- Patients prone to hypotension or other intradialytic adverse events.
- Patients participating in another interventional study that may affect blood pressure.
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 |
|---|---|---|
| standard hemodialysispatients who will undergo standard hemodialysis (dialysate sodium concentration 143 mmoL/L) | Procedure or surgery | Group A: standard hemodialysis. |
| lower dialysate sodium dialysispatients who will undergo hemodialysis with lower dialysate sodium concentration (140 mmoL/L) | Procedure or surgery | Group B: lower dialysate sodium hemodialysis. |
Primary outcome
blood pressure variability.
Time frame: 2 weeks after the study duration (3 months).
visit to visit blood pressure variability in both groups.
3 secondary outcomes
interdialytic weight gain
Time frame: 2 weeks after the study duration (3 months).
antihypertensive medication regimen
Time frame: 2 weeks after the study duration (3 months).
the frequency of intradialytic adverse events
Time frame: 2 weeks after the study duration (3 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Derived from this study: PubMed 41649081Abdulaziz HMM, Gomaa H, El-Said G. Improvement of visit-to-visit SBP variability with lowering dialysate sodium concentration in patients undergoing hemodialysis: a randomized controlled trial. J Hypertens. 2026 Apr 1;44(4):629-635. doi: 10.1097/HJH.0000000000004243. Epub 2026 Jan 22.
- 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.
Hoda Abdulaziz, Lecturer contact
Ghada El-said, Ass. Prof. study chair
Mansoura University
Questions about this trial
What is this clinical trial studying?
A study testing standard hemodialysis and lower dialysate sodium dialysis in people with Hemodialysis Patients, run by Mansoura University.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghada El-said, Ass. Prof. (01019080448, ghadaalsaid222@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure variability. (time frame: 2 weeks after the study duration (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 NCT05169125, which also lists 2 linked publications.
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 23 Dec 2021.