Kidney Failure, ChronicNCT00141609
Haemodialysis Salt Reduction Study
A study testing Slow Sodium in people with Kidney Failure, Chronic and Hypertension, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
High blood pressure (hypertension) affects up to 80% of all patients receiving haemodialysis for chronic kidney disease (CKD). High blood pressure is a major cause cardiovascular disease (i.e. strokes, heart attacks and heart failure) and, thereby, cardiovascular deaths in these patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Kidney Failure, Chronic, Hypertension
- What is being tested?
- Slow Sodium
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2004to Oct 2006
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Haemodialysis/haemodiafiltration for ESRF for >3 months
- Clinically stable
Who cannot join
- Significant intercurrent illness
- Systolic BP >240 mmHg/diastolic BP >120 mmHg at enrollment
- Unstable blood pressure whilst on HD
- Sodium profiled haemodialysis/HDF
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Blood Pressure Unit, Cardiac & Vascular Sciences, SGUL
London, SW17 0RE
About this study
Official title: A Study Looking at the Effects of a Modest Reduction in Dietary Salt Intake on Blood Pressure Control in Haemodialysis Patients
High blood pressure (hypertension) affects up to 80% of all patients receiving haemodialysis for chronic kidney disease (CKD). High blood pressure is a major cause cardiovascular disease (i.e. strokes, heart attacks and heart failure) and, thereby, cardiovascular deaths in these patients.
A significant cause of raised blood pressure in haemodialysis patients is thought to be due to retention of salt in the body. In healthy people the kidneys excrete salt but the kidneys of patients with CKD cannot do this, so salt has to be removed by dialysis. However dialysis cannot remove as much salt as is necessary, and so it accumulates. This fact has been recognized for many years, and health professionals caring for haemodialysis patients often stress the importance of restriction of dietary salt intake.
Read more
However no research has looked in detail at the mechanisms by which salt raises blood pressure in haemodialysis patients. It is likely that salt directly affects thirst, causing patients to drink more and become overloaded with fluid. In addition, salt may have direct effects on the blood vessel wall, causing failure of adequate blood vessel relaxation. Both of these factors may raise blood pressure.
We will conduct a carefully controlled crossover study looking at the effects of a modest reduction in salt intake on BP. During the course of the study, which will last eight weeks, patients will receive both a 5 gram per day and a 10 gram per day salt intake. We will look at how thirst, fluid intake, a number of markers of blood vessel function and blood pressure differ on these two salt intakes.
Read the detailed description
High blood pressure (BP) is a major independent risk factor for cardiovascular mortality in individuals on haemodialysis, and yet BP is extremely poorly controlled in this population.
Excessive dietary salt intake is likely to be a major cause of hypertension in these patients. Firstly, excessive salt intake will result in thirst, excessive fluid intake and weight gains between dialysis, and thereby chronic over-expansion of extracellular fluid volumes resulting in high blood pressure. Secondly, salt may have direct effects on the arterial tree contributing to endothelial dysfunction that has clearly been demonstrated in uraemic individuals, including haemodialysis patients. Abnormalities in endothelial nitric oxide (NO) production may play an important role in salt-sensitive hypertension, mediated by the potent inhibitor of NO synthase, asymmetrical dimethylarginine (ADMA). Plasma ADMA concentrations are several-fold higher in individuals on dialysis than in normal controls, and it would be of interest to see whether ADMA concentrations decrease with a reduction dietary salt intake.
In spite of the importance of dietary salt intake in haemodialysis patients, there are no controlled studies which delineate the mechanisms by which salt intake affects BP. We propose to conduct a prospective double-blind placebo controlled cross-over study of normal (10 to 12 grams salt per day) versus modestly reduced (6 grams per day) salt intake over an eight week period in haemodialysis patients. The primary outcome measure is the change in pre-dialysis systolic BP. Other outcome measures include mean systolic and diastolic BP as measured by ABPM, thirst scores, daily weight gains and thoracic fluid content, as measured by thoracic bioimpedance. Furthermore, in a sub-group of subjects will we study the changes in plasma ADMA concentrations with reductions in salt intake, and examine correlations with changes in BP and systemic vascular resistance.
- Conditions
- Kidney Failure, Chronic, Hypertension
- Being tested
- Slow Sodium
- Keywords
- End-stage renal failure, Haemodialysis, Sodium, Blood Pressure
- Medical subject headings
- Kidney Failure, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow SodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pre-dialysis systolic blood pressure
Secondary outcomes (5)
Change in post-dialysis ambulatory BP (24 hr)
Change in thirst score
Change in intra-dialytic weight gain
Change in systemic vascular resistance
Change in assymmetric dimethylarginine (ADMA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startApr 2004
- Study completionOct 2006
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 Kidney Failure, ChronicStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Investigators
- Timothy WR Doulton, MBBS BSc MRCP, Principal investigator, SGUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141609
- Sponsor's protocol ID
- LREC 04.0013
- Status last verified
- May 2007
- First submitted
- 31 Aug 2005
- Last updated
- 14 May 2007
- Results posted
- No
Publications
McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
PubMed 34164803
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Looking at the Effects of a Modest Reduction in Dietary Salt Intake on Blood Pressure Control in Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT00141609
- Acronym / sponsor ID
- LREC 04.0013
- Conditions
- Kidney Failure, Chronic, Hypertension
- Keywords
- End-stage renal failure, Haemodialysis, Sodium, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Oct 2006
- First posted
- 1 Sep 2005 (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.
High blood pressure (hypertension) affects up to 80% of all patients receiving haemodialysis for chronic kidney disease (CKD). High blood pressure is a major cause cardiovascular disease (i.e. strokes, heart attacks and heart failure) and, thereby, cardiovascular deaths in these patients.
A significant cause of raised blood pressure in haemodialysis patients is thought to be due to retention of salt in the body. In healthy people the kidneys excrete salt but the kidneys of patients with CKD cannot do this, so salt has to be removed by dialysis. However dialysis cannot remove as much salt as is necessary, and so it accumulates. This fact has been recognized for many years, and health professionals caring for haemodialysis patients often stress the importance of restriction of dietary salt intake.
However no research has looked in detail at the mechanisms by which salt raises blood pressure in haemodialysis patients. It is likely that salt directly affects thirst, causing patients to drink more and become overloaded with fluid. In addition, salt may have direct effects on the blood vessel wall, causing failure of adequate blood vessel relaxation. Both of these factors may raise blood pressure.
We will conduct a carefully controlled crossover study looking at the effects of a modest reduction in salt intake on BP. During the course of the study, which will last eight weeks, patients will receive both a 5 gram per day and a 10 gram per day salt intake. We will look at how thirst, fluid intake, a number of markers of blood vessel function and blood pressure differ on these two salt intakes.
Detailed description
High blood pressure (BP) is a major independent risk factor for cardiovascular mortality in individuals on haemodialysis, and yet BP is extremely poorly controlled in this population.
Excessive dietary salt intake is likely to be a major cause of hypertension in these patients. Firstly, excessive salt intake will result in thirst, excessive fluid intake and weight gains between dialysis, and thereby chronic over-expansion of extracellular fluid volumes resulting in high blood pressure. Secondly, salt may have direct effects on the arterial tree contributing to endothelial dysfunction that has clearly been demonstrated in uraemic individuals, including haemodialysis patients. Abnormalities in endothelial nitric oxide (NO) production may play an important role in salt-sensitive hypertension, mediated by the potent inhibitor of NO synthase, asymmetrical dimethylarginine (ADMA). Plasma ADMA concentrations are several-fold higher in individuals on dialysis than in normal controls, and it would be of interest to see whether ADMA concentrations decrease with a reduction dietary salt intake.
In spite of the importance of dietary salt intake in haemodialysis patients, there are no controlled studies which delineate the mechanisms by which salt intake affects BP. We propose to conduct a prospective double-blind placebo controlled cross-over study of normal (10 to 12 grams salt per day) versus modestly reduced (6 grams per day) salt intake over an eight week period in haemodialysis patients. The primary outcome measure is the change in pre-dialysis systolic BP. Other outcome measures include mean systolic and diastolic BP as measured by ABPM, thirst scores, daily weight gains and thoracic fluid content, as measured by thoracic bioimpedance. Furthermore, in a sub-group of subjects will we study the changes in plasma ADMA concentrations with reductions in salt intake, and examine correlations with changes in BP and systemic vascular resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Haemodialysis/haemodiafiltration for ESRF for >3 months
- Clinically stable
Key exclusion criteria (4 listed)
- Significant intercurrent illness
- Systolic BP >240 mmHg/diastolic BP >120 mmHg at enrollment
- Unstable blood pressure whilst on HD
- Sodium profiled haemodialysis/HDF
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 |
|---|---|---|
| Slow Sodium | Drug | – |
Primary outcome
Change in pre-dialysis systolic blood pressure
5 secondary outcomes
Change in post-dialysis ambulatory BP (24 hr)
Change in thirst score
Change in intra-dialytic weight gain
Change in systemic vascular resistance
Change in assymmetric dimethylarginine (ADMA)
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 May 2007.
- Derived from this study: PubMed 34164803McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.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.
Timothy WR Doulton, MBBS BSc MRCP principal investigator
SGUL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow Sodium in people with Kidney Failure, Chronic and Hypertension, run by St George's, University of London at 1 site in United Kingdom.
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 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: finished, as of the sponsor's last update on 14 May 2007. 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 United Kingdom. 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?
Change in pre-dialysis systolic blood pressure. 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 NCT00141609, 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 May 2007.