HypertensionNCT01455974
The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients
A study testing Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L in people with Hypertension and Arteriosclerosis, run by Capital Medical University at 1 site in China.
Trial summary
Unfavorably high sodium intakes remain prevalent around the world. A negative sodium gradient in hemodialysis treatment results in absolute sodium removal via diffusive transport of sodium from the blood to the dialysate, and it may be a potentially useful tool to improve sodium loading due to excess dietary sodium… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension, Arteriosclerosis, Left Ventricular Hypertrophy
- What is being tested?
- Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Sep 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They had been on HD for more than 1 year.
- They had had no clinical cardiovascular disease during 3 months preceding entry into the study, with left ventricular ejection fraction over 40%.
- Their residual daily urine output was lower than 100 ml/day.
- They had achieved their dry weight assessed by bioimpedance technique and clinical examination for at least 3 months.
- A mean interdialytic ambulatory BP of >135/85 mmHg.
- Averaging the last six available monthly pre-dialysis plasma sodium concentrations over the preceding 12 months >138mmol/l.
Who cannot join
- They had known acute inflammatory event, malignant disease, and the serum albumine<30g/l.
- They were diabetic and hypotension prone.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nephrology, Chao-Yang Hospital, Capital Medical University
Beijing, 100020
About this study
Unfavorably high sodium intakes remain prevalent around the world. A negative sodium gradient in hemodialysis treatment results in absolute sodium removal via diffusive transport of sodium from the blood to the dialysate, and it may be a potentially useful tool to improve sodium loading due to excess dietary sodium intake.
The purpose of this study is to determine whether a in small negative sodium gradient could improve blood pressure level, arterial stiffness and left ventricular hypertrophy in hypertensive hemodialysis patients, who had been achieving and maintaining their dry weight assessed by bioimpedance spectroscopy.
Read the detailed description
A number of studies have shown that lowering dialysate sodium concentration could improve blood pressure (BP) control, and the lower BPs are considered to be a result of an improvement in volume status via increasing sodium removal. However, sodium, apart from volume, may have an independent effect on BP regulation. It is speculated that a reduction in exchangeable sodium, even without a change in body water content, may improve BP control. Unfortunately, as of yet, no clinical studies have actually provided the evidence in this field.
In general population, dietary salt loading produces significant increase in aortic pulse wave velocity, which is reversed by lowering sodium intake. To the investigators knowledge, the effect of sodium on arterial stiffness has not been investigated in hemodialysis patients.
A regression of left ventricular hypertrophy (LVH) has been achieved through strict dietary sodium restriction in hemodialysis patients. Lack of effect on LVH was observed in low sodium dialysis which may be due to the shorter time interval.
- Conditions
- Hypertension, Arteriosclerosis, Left Ventricular Hypertrophy
- Being tested
- Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L
- Keywords
- hypertension, arterial stiffness, left ventricular hypertrophy
- Medical subject headings
- Hypertension, Arteriosclerosis, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decreasing dialysate sodium from 138 mmol/L to 136 mmol/LOther
After 1-month period of dialysis with standard dialysate sodium concentration 138mmol/L, patients were followed up over a 1-year period with dialysate sodium set at 136mmol/L, without changes in instructions to patients about dietary sodium.
| Study group | Role | What they receive |
|---|---|---|
| Dialysate sodium set at 136 mmol/L | Experimental | Not described Receives: Other: Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 44-hour ambulatory systolic and diastolic blood pressure
The change is calculated as the 4 months minus baseline, and the 12 months minus baseline
Measured: Baseline, 4 months, and 12 months
Secondary outcomes (1)
Changes in aortic pulse wave velocity and left ventricular mass index
The change is calculated as the 4 months minus baseline, and the 12 months minus baseline
Measured: Baseline, 4 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Capital Medical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Lun Zhou, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455974
- Sponsor's protocol ID
- 001
- Status last verified
- Oct 2011
- First submitted
- 28 Sep 2011
- Last updated
- 20 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01455974
- Acronym / sponsor ID
- 001
- Conditions
- Hypertension, Arteriosclerosis, Left Ventricular Hypertrophy
- Keywords
- hypertension, arterial stiffness, left ventricular hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Oct 2011 (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.
Unfavorably high sodium intakes remain prevalent around the world. A negative sodium gradient in hemodialysis treatment results in absolute sodium removal via diffusive transport of sodium from the blood to the dialysate, and it may be a potentially useful tool to improve sodium loading due to excess dietary sodium intake.
The purpose of this study is to determine whether a in small negative sodium gradient could improve blood pressure level, arterial stiffness and left ventricular hypertrophy in hypertensive hemodialysis patients, who had been achieving and maintaining their dry weight assessed by bioimpedance spectroscopy.
Detailed description
A number of studies have shown that lowering dialysate sodium concentration could improve blood pressure (BP) control, and the lower BPs are considered to be a result of an improvement in volume status via increasing sodium removal. However, sodium, apart from volume, may have an independent effect on BP regulation. It is speculated that a reduction in exchangeable sodium, even without a change in body water content, may improve BP control. Unfortunately, as of yet, no clinical studies have actually provided the evidence in this field.
In general population, dietary salt loading produces significant increase in aortic pulse wave velocity, which is reversed by lowering sodium intake. To the investigators knowledge, the effect of sodium on arterial stiffness has not been investigated in hemodialysis patients.
A regression of left ventricular hypertrophy (LVH) has been achieved through strict dietary sodium restriction in hemodialysis patients. Lack of effect on LVH was observed in low sodium dialysis which may be due to the shorter time interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialysate sodium set at 136 mmol/L | Experimental | Other: Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- They had been on HD for more than 1 year.
- They had had no clinical cardiovascular disease during 3 months preceding entry into the study, with left ventricular ejection fraction over 40%.
- Their residual daily urine output was lower than 100 ml/day.
- They had achieved their dry weight assessed by bioimpedance technique and clinical examination for at least 3 months.
- A mean interdialytic ambulatory BP of >135/85 mmHg.
Key exclusion criteria (2 listed)
- They had known acute inflammatory event, malignant disease, and the serum albumine<30g/l.
- They were diabetic and hypotension prone.
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 |
|---|---|---|
| Decreasing dialysate sodium from 138 mmol/L to 136 mmol/LAfter 1-month period of dialysis with standard dialysate sodium concentration 138mmol/L, patients were followed up over a 1-year period with dialysate sodium set at 136mmol/L, without changes in instructions to patients about dietary sodium. | Other | Dialysate sodium set at 136 mmol/L |
Primary outcome
Changes in 44-hour ambulatory systolic and diastolic blood pressure
Time frame: Baseline, 4 months, and 12 months
The change is calculated as the 4 months minus baseline, and the 12 months minus baseline
1 secondary outcome
Changes in aortic pulse wave velocity and left ventricular mass index
Time frame: Baseline, 4 months, and 12 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 20 Oct 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L in people with Hypertension and Arteriosclerosis, run by Capital Medical University at 1 site in China.
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 6 inclusion and 2 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 20 Oct 2011. 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 China. 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.
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?
Changes in 44-hour ambulatory systolic and diastolic blood pressure (time frame: Baseline, 4 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2011.