HaemodialysisSASHNCT05128188
SASH: Sodium Accumulation Study In Haemodialysis
An observational study of Haemodialysis and End Stage Renal Disease on Dialysis, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Haemodialysis (HD) sustains life in patients with end-stage kidney disease (ESKD) but is associated with a marked increase in incidence of cardiovascular disease (CVD) and high annual mortality rates. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Haemodialysis, End Stage Renal Disease on Dialysis
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2022to 2 Sep 2023
- Phase
- Observational
- 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 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 5 participants will be recruited from the renal unit
Who may be able to join
- Age 50-75 years inclusive
- Male patients with CKD stage 5 receiving chronic haemodialysis
- Patient has been dialysis dependent for at least 3 months
- Must be able to follow simple instruction in English (on safety ground for MRI scans) and be able to understand the nature and requirements of the study
Who cannot join
- Active infection or malignancy
- Amputee
- Pregnancy
- Contraindication to MRI scanning including claustrophobia, pacemaker, metallic implants etc
- Unable or unwilling to provide informed consent
- Medical conditions or overall physical frailty precludes scan session in opinion of investigator
- Any condition which could interfere with the patient's ability to comply with the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, DE22 3NE
About this study
Official title: Sodium Accumulation Study In Haemodialysis
Haemodialysis (HD) sustains life in patients with end-stage kidney disease (ESKD) but is associated with a marked increase in incidence of cardiovascular disease (CVD) and high annual mortality rates. The pathogenesis of CVD in patients on HD is multifactorial and complex but hypertension is thought to be a major contributing factor. Sodium balance is normally regulated by the kidneys in health but has to be achieved by sodium removal during HD for those with ESKD. Recent evidence suggests that accumulation of sodium in the skin and / or muscle may be a critical factor impacting the development of hypertension and CVD in patients with ESKD and non-invasive methods are therefore required to study tissue sodium accumulation in this context. This study aims to determine the change in skin and muscle sodium content in patients undergoing haemodialysis. Participants will have a single haemodialysis session, and undergo two MRI scans (one prior to and one following dialysis).
Read the detailed description
It has been proposed that tissue sodium accumulation in skin and/or muscle is a key factor in hypertension. 23Na MRI allows the assessment of skin and muscle sodium storage and will therefore be a valuable tool in elucidating the role of tissue sodium accumulation in the pathogenesis of salt-sensitive hypertension and cardiovascular morbidity and mortality. Moreover, if haemodialysis in patients with end-stage kidney disease (ESKD) results in changes in tissue sodium, the development of 23Na skin and muscle measures would allow for a method to correlate skin tissue sodium content with detailed cardiovascular and functional assessments.
Participants will have a single haemodialysis session, and undergo two MRI scans (one prior to and one following dialysis), in conjunction with clinical data collection (eg. blood samples, bioimpedance analysis, skin autoflorescence).
- Conditions
- Haemodialysis, End Stage Renal Disease on Dialysis
- Being tested
- No intervention will be given in this study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be given in this studyOther
No intervention will be given in this study
| Study group | Role | What they receive |
|---|---|---|
| Patients on haemodialysis | 5 patients on haemodialysis will be recruited. The study involves a single dialysis session and two MRI scans (one prior and one following dialysis) and collection of clinical data. Receives: Other: No intervention will be given in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ascertainment of MRI measures of skin sodium content in 100% of patients studied
Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques.
Measured: 6 months
Ascertainment of MRI measures of muscle sodium content in 100% of patients studied
Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques.
Measured: 6 months
Secondary outcomes (4)
To study skin sodium in haemodialysis patients and compare with previously reported healthy normal values
Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques
Measured: 6 months
To study muscle sodium in haemodialysis patients and compare with previously reported healthy normal values
Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques
Measured: 6 months
To measure degree of change in skin sodium content in relation to a single haemodialysis treatment
Quantification of sodium in skin and muscle and compare finding before and after dialysis
Measured: 6 months
To measure degree of change in muscle sodium content in relation to a single haemodialysis treatment
Quantification of sodium in skin and muscle and compare finding before and after dialysis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Mar 2022
- Primary completion2 Aug 2023
- Study completion2 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemodialysisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Selby, University Hospitals of Derby and Burton NHS Foundation Trust
- Investigators
- Nicholas Selby, Professor, Principal investigator, University Hospitals of Derby and Burton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128188
- Sponsor's protocol ID
- UHDB/2021/020
- Acronym
- SASH
- Status last verified
- Aug 2024
- First submitted
- 5 Nov 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Accumulation Study In Haemodialysis
- ClinicalTrials.gov ID
- NCT05128188
- Acronym / sponsor ID
- SASH / UHDB/2021/020
- Conditions
- Haemodialysis, End Stage Renal Disease on Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 19 Nov 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.
Haemodialysis (HD) sustains life in patients with end-stage kidney disease (ESKD) but is associated with a marked increase in incidence of cardiovascular disease (CVD) and high annual mortality rates. The pathogenesis of CVD in patients on HD is multifactorial and complex but hypertension is thought to be a major contributing factor. Sodium balance is normally regulated by the kidneys in health but has to be achieved by sodium removal during HD for those with ESKD. Recent evidence suggests that accumulation of sodium in the skin and / or muscle may be a critical factor impacting the development of hypertension and CVD in patients with ESKD and non-invasive methods are therefore required to study tissue sodium accumulation in this context. This study aims to determine the change in skin and muscle sodium content in patients undergoing haemodialysis. Participants will have a single haemodialysis session, and undergo two MRI scans (one prior to and one following dialysis).
Detailed description
It has been proposed that tissue sodium accumulation in skin and/or muscle is a key factor in hypertension. 23Na MRI allows the assessment of skin and muscle sodium storage and will therefore be a valuable tool in elucidating the role of tissue sodium accumulation in the pathogenesis of salt-sensitive hypertension and cardiovascular morbidity and mortality. Moreover, if haemodialysis in patients with end-stage kidney disease (ESKD) results in changes in tissue sodium, the development of 23Na skin and muscle measures would allow for a method to correlate skin tissue sodium content with detailed cardiovascular and functional assessments.
Participants will have a single haemodialysis session, and undergo two MRI scans (one prior to and one following dialysis), in conjunction with clinical data collection (eg. blood samples, bioimpedance analysis, skin autoflorescence).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on haemodialysis | – | Other: No intervention will be given in this study5 patients on haemodialysis will be recruited. The study involves a single dialysis session and two MRI scans (one prior and one following dialysis) and collection of clinical data. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 5 participants will be recruited from the renal unit
Key inclusion criteria (4 listed)
- Age 50-75 years inclusive
- Male patients with CKD stage 5 receiving chronic haemodialysis
- Patient has been dialysis dependent for at least 3 months
- Must be able to follow simple instruction in English (on safety ground for MRI scans) and be able to understand the nature and requirements of the study
Key exclusion criteria (7 listed)
- Active infection or malignancy
- Amputee
- Pregnancy
- Contraindication to MRI scanning including claustrophobia, pacemaker, metallic implants etc
- Unable or unwilling to provide informed consent
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 |
|---|---|---|
| No intervention will be given in this studyNo intervention will be given in this study | Other | Patients on haemodialysis |
Primary outcome
Ascertainment of MRI measures of skin sodium content in 100% of patients studied
Time frame: 6 months
Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques.
Ascertainment of MRI measures of muscle sodium content in 100% of patients studied
Time frame: 6 months
Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques.
4 secondary outcomes
To study skin sodium in haemodialysis patients and compare with previously reported healthy normal values
Time frame: 6 months
To study muscle sodium in haemodialysis patients and compare with previously reported healthy normal values
Time frame: 6 months
To measure degree of change in skin sodium content in relation to a single haemodialysis treatment
Time frame: 6 months
To measure degree of change in muscle sodium content in relation to a single haemodialysis treatment
Time frame: 6 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 9 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Haemodialysis
Not yet recruitingObservational study
Artificial Intelligence - Based Opportunistic Coronary Artery Calcium Scoring on Routine Chest-CT Scan
Coronary Artery Calcification, Cardiovascular Risk
Active, not recruiting
DisTal Arterio-Venous Fistula Feasibility
End-Stage Renal Disease Requiring Haemodialysis
Recruiting
Colchicine And Dialysis Patients; a Feasibility Study
Haemodialysis Patients, Colchicine
Recruiting
Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis
End-Stage Renal Disease Requiring Haemodialysis
RecruitingObservational study
Adequacy of Haemodiafiltration: Middle Molecules Clearance, Patients Reported Outcomes and Sodium Balance
Haemodiafiltration, Haemodialysis
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.
Nicholas Selby, Professor principal investigator
University Hospitals of Derby and Burton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemodialysis and End Stage Renal Disease on Dialysis, run by University Hospitals of Derby and Burton NHS Foundation Trust 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 4 inclusion and 7 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 9 Aug 2024. 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?
Ascertainment of MRI measures of skin sodium content in 100% of patients studied (time frame: 6 months). The study lists 2 primary outcomes in all. 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 9 Aug 2024; AzTrials last refreshed its copy on 1 Nov 2026.