Haemodialysis ComplicationNCT03004547
Sodium Deposition in Soft Tissues of Patients with Kidney Disease
An observational study of Haemodialysis Complication, run by Chris McIntyre at 1 site in Canada.
Trial summary
Sodium (Na+) hemostasis is abnormal in CKD patients, and this element can be deposited in the skin, muscle, and skeleton - to cope with long term sodium loading. It is known that sodium stored in this non-osmotically active way, is profoundly inflammatory. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Haemodialysis Complication
- What is being tested?
- Measuring sodium content
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 5 Mar 2018to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We will recruit up to 400 participants; approximately 125 dialysis patients including 50 children/adolescents on dialysis, 200 patients with various stages of chronic kidney disease including heart failure patients and approximately 25 children/adolescents with chronic kidney disease, and 75 individuals with no kidney disease including approximately 25 healthy children/adolescents.
Who may be able to join
- Age greater than or equal to 6 years
- For patients on maintenance hemodialysis or peritoneal dialysis: more than 3 months duration of therapy
- For patients with CKD stage 1-5: CKD stage 1-5 and no indications to start dialysis
- For heart failure patients: with or without renal dysfunction
- For healthy controls: lack of kidney disease, heart failure, liver cirrhosis, and peripheral edema
- For subsequent visits (must meet 1 of the below indicators):
Show all 11Show fewer
- Change in dialysis prescription
- Change in renal replacement therapy modality
- Change in medication
- Parathyroidectomy
- Intervention added to or removed from dialysis (i.e. such as but not limited exercise, cooling, and ischemic preconditioning)
Who cannot join
- Pregnant, breastfeeding or intending pregnancy
- Unable to give consent or understand written information
- Contraindication to MRI study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alireza Akbari, PhD contact
Canada1 site, 1 recruiting
- Recruiting
LHSC Regional Renal Care Program
London, Ontario
Christopher W McIntyre, MD, PhD, 519-685-8500 ext. 58502, christopher.mcintyre@lhsc.on.cas
Alireza Akbari, PhD
About this study
Official title: Evaluation of Sodium Deposition in Soft Tissues of Patients with Kidney Disease and Its Association with Patient Symptomatology
Sodium (Na+) hemostasis is abnormal in CKD patients, and this element can be deposited in the skin, muscle, and skeleton - to cope with long term sodium loading. It is known that sodium stored in this non-osmotically active way, is profoundly inflammatory. Furthermore, inflammation has been associated with several uremic symptoms. The investigators will use novel Na+ MRI imaging to examine the Na+ deposition in the skin, muscle, and skeleton of five groups:1) chronic in-center hemodialysis patients, 2) chronic peritoneal dialysis patients, 3) adult and paediatric patients with CKD stage 1-5 and 4) heart failure patients with and without renal dysfunction 5) sex and age-matched healthy adult and paediatric controls. Additionally, they will investigate the association between sodium deposition in these tissues with uremic symptomatology and biochemical markers of metabolism.
Read the detailed description
Kidneys have a key role in sodium hemostasis through their excretory function. In patients with chronic kidney disease (CKD), kidney function is impaired; thus, suggesting that sodium handling is abnormal in this setting with long-term sodium loading (from oral intake) and lack of adequate urinary excretion. Yet, sodium concentration needs to stay relatively constant to prevent fatal intra-cellular accumulation, which would result in cell injury and death. In hemodialysis patients, at least a part of this extra sodium is non-osmotically active and deposited in the skin, muscle, and skeleton.
Furthermore, it has become increasingly recognized that sodium (once accumulated in tissues) is directly pro-inflammatory, affecting the innate immune system by regulating the activity of macrophages in skin. This linkage between sodium and inflammation indicates a potential link between sodium deposition and uremic symptoms experienced by patients.
There have been no studies to date examining the sodium deposition in the skin, muscle, and skeleton of patients with different kidney function and renal replacement therapy.
This is a pilot study involving a single center recruiting patients from the prevalent maintenance hemodialysis, peritoneal dialysis , CKD stage 1-5, and heart failure populations of London, Ontario, compared to healthy controls. Once recruited, participants will undergo one study visit with the potential of up to two follow-up visits (on a non-dialysis day for hemodialysis patients). Participants will be followed for up to two years after the first study visit. Each session will include symptom questionnaires, the five times sit to stand and 60-second chair stand test (excluding all children), blood pressure and heart rate measurements, blood work (excluding healthy children and adolescents), urine sampling (excluding those on dialysis), an echocardiogram (excluding healthy controls), and an MRI scan of the lower leg detecting sodium content.
- Conditions
- Haemodialysis Complication
- Being tested
- Measuring sodium content
- Keywords
- Sodium, Soft Tissues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring sodium contentOther
Sodium MRI measurement of sodium content in the tissues of all participants
| Study group | Role | What they receive |
|---|---|---|
| Chronic hemodialysis patients | Patients on standard in-centre 3 times a week hemodialysis Receives: Other: Measuring sodium content | |
| Peritoneal dialysis patients | Patients on peritoneal dialysis Receives: Other: Measuring sodium content | |
| Adult and paediatric patients with CKD stage 1-5 | Patients with chronic kidney disease stage 1-5 (not dialysis dependent) Receives: Other: Measuring sodium content | |
| Healthy adult and paediatric controls | Subjects without kidney disease Receives: Other: Measuring sodium content | |
| Heart failure patients with and without renal dysfunction | Heart failure patients (atrial fibrillation etc ...) with and without renal dysfunction Receives: Other: Measuring sodium content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Na content in the skin, muscle and skeleton of five cohorts
Measured: 2 years
Secondary outcomes (8)
Inflammatory Marker: CRP levels
Measured: 2 years
Uremic symptom scores among the different groups
Measured: 2 years
Liver function markers
Measured: 2 years
Liver damage markers (liver enzymes)
Measured: 2 years
cardiac markers (troponin)
Measured: 2 years
bone markers (ALP, vitamin D levels)
Measured: 2 years
Uremic toxin levels
Measured: 3-4 years
Endotoxin levels
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start5 Mar 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
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 Haemodialysis ComplicationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chris McIntyre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Christopher W McIntyre, PhD, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004547
- Sponsor's protocol ID
- 108765
- Status last verified
- Feb 2025
- First submitted
- 16 Dec 2016
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lemoine S, Salerno FR, Akbari A, McKelvie RS, McIntyre CW. Tissue Sodium Storage in Patients With Heart Failure: A New Therapeutic Target? Circ Cardiovasc Imaging. 2021 Nov;14(11):e012910. doi: 10.1161/CIRCIMAGING.121.012910. Epub 2021 Nov 16.
PubMed 34784242
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sodium Deposition in Soft Tissues of Patients with Kidney Disease and Its Association with Patient Symptomatology
- ClinicalTrials.gov ID
- NCT03004547
- Acronym / sponsor ID
- 108765
- Conditions
- Haemodialysis Complication
- Keywords
- Sodium, Soft Tissues
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chris McIntyreUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 29 Dec 2016 (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.
Sodium (Na+) hemostasis is abnormal in CKD patients, and this element can be deposited in the skin, muscle, and skeleton - to cope with long term sodium loading. It is known that sodium stored in this non-osmotically active way, is profoundly inflammatory. Furthermore, inflammation has been associated with several uremic symptoms. The investigators will use novel Na+ MRI imaging to examine the Na+ deposition in the skin, muscle, and skeleton of five groups:1) chronic in-center hemodialysis patients, 2) chronic peritoneal dialysis patients, 3) adult and paediatric patients with CKD stage 1-5 and 4) heart failure patients with and without renal dysfunction 5) sex and age-matched healthy adult and paediatric controls. Additionally, they will investigate the association between sodium deposition in these tissues with uremic symptomatology and biochemical markers of metabolism.
Detailed description
Kidneys have a key role in sodium hemostasis through their excretory function. In patients with chronic kidney disease (CKD), kidney function is impaired; thus, suggesting that sodium handling is abnormal in this setting with long-term sodium loading (from oral intake) and lack of adequate urinary excretion. Yet, sodium concentration needs to stay relatively constant to prevent fatal intra-cellular accumulation, which would result in cell injury and death. In hemodialysis patients, at least a part of this extra sodium is non-osmotically active and deposited in the skin, muscle, and skeleton.
Furthermore, it has become increasingly recognized that sodium (once accumulated in tissues) is directly pro-inflammatory, affecting the innate immune system by regulating the activity of macrophages in skin. This linkage between sodium and inflammation indicates a potential link between sodium deposition and uremic symptoms experienced by patients.
There have been no studies to date examining the sodium deposition in the skin, muscle, and skeleton of patients with different kidney function and renal replacement therapy.
This is a pilot study involving a single center recruiting patients from the prevalent maintenance hemodialysis, peritoneal dialysis , CKD stage 1-5, and heart failure populations of London, Ontario, compared to healthy controls. Once recruited, participants will undergo one study visit with the potential of up to two follow-up visits (on a non-dialysis day for hemodialysis patients). Participants will be followed for up to two years after the first study visit. Each session will include symptom questionnaires, the five times sit to stand and 60-second chair stand test (excluding all children), blood pressure and heart rate measurements, blood work (excluding healthy children and adolescents), urine sampling (excluding those on dialysis), an echocardiogram (excluding healthy controls), and an MRI scan of the lower leg detecting sodium content.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Chronic hemodialysis patients | – | Other: Measuring sodium contentPatients on standard in-centre 3 times a week hemodialysis |
| Peritoneal dialysis patients | – | Other: Measuring sodium contentPatients on peritoneal dialysis |
| Adult and paediatric patients with CKD stage 1-5 | – | Other: Measuring sodium contentPatients with chronic kidney disease stage 1-5 (not dialysis dependent) |
| Healthy adult and paediatric controls | – | Other: Measuring sodium contentSubjects without kidney disease |
| Heart failure patients with and without renal dysfunction | – | Other: Measuring sodium contentHeart failure patients (atrial fibrillation etc ...) with and without renal dysfunction |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will recruit up to 400 participants; approximately 125 dialysis patients including 50 children/adolescents on dialysis, 200 patients with various stages of chronic kidney disease including heart failure patients and approximately 25 children/adolescents with chronic kidney disease, and 75 individuals with no kidney disease including approximately 25 healthy children/adolescents.
Key inclusion criteria (11 listed)
- Age greater than or equal to 6 years
- For patients on maintenance hemodialysis or peritoneal dialysis: more than 3 months duration of therapy
- For patients with CKD stage 1-5: CKD stage 1-5 and no indications to start dialysis
- For heart failure patients: with or without renal dysfunction
- For healthy controls: lack of kidney disease, heart failure, liver cirrhosis, and peripheral edema
Key exclusion criteria (3 listed)
- Pregnant, breastfeeding or intending pregnancy
- Unable to give consent or understand written information
- Contraindication to MRI 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 |
|---|---|---|
| Measuring sodium contentSodium MRI measurement of sodium content in the tissues of all participants | Other | Adult and paediatric patients with CKD stage 1-5, Chronic hemodialysis patients, Healthy adult and paediatric controls, Heart failure patients with and without renal dysfunction, Peritoneal dialysis patients |
Primary outcome
Na content in the skin, muscle and skeleton of five cohorts
Time frame: 2 years
8 secondary outcomes
Inflammatory Marker: CRP levels
Time frame: 2 years
Uremic symptom scores among the different groups
Time frame: 2 years
Liver function markers
Time frame: 2 years
Liver damage markers (liver enzymes)
Time frame: 2 years
cardiac markers (troponin)
Time frame: 2 years
bone markers (ALP, vitamin D levels)
Time frame: 2 years
Uremic toxin levels
Time frame: 3-4 years
Endotoxin levels
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 34784242Lemoine S, Salerno FR, Akbari A, McKelvie RS, McIntyre CW. Tissue Sodium Storage in Patients With Heart Failure: A New Therapeutic Target? Circ Cardiovasc Imaging. 2021 Nov;14(11):e012910. doi: 10.1161/CIRCIMAGING.121.012910. Epub 2021 Nov 16.
- 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.
Alireza Akbari, PhD contact
Christopher W McIntyre, PhD, MD principal investigator
Western University, Canada
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 Complication, run by Chris McIntyre at 1 site in Canada.
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 11 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher W McIntyre, PhD, MD (519-685-8500 ext. 58502, christopher.mcintyre@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Na content in the skin, muscle and skeleton of five cohorts (time frame: 2 years). 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 NCT03004547, 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 12 Feb 2025.