Examining sodium buildup in tissues of kidney disease patients
Evaluation of Sodium Deposition in Soft Tissues of Patients with Kidney Disease and Its Association with Patient Symptomatology
This study is testing how sodium builds up in the skin, muscles, and bones of people with chronic kidney disease and those on dialysis to see how it relates to their symptoms and health markers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT03004547 on ClinicalTrials.gov |
What this trial studies
This observational study investigates sodium deposition in the skin, muscle, and skeleton of patients with chronic kidney disease (CKD) and those undergoing dialysis. Using novel sodium MRI imaging, the study will compare sodium levels across five groups: chronic hemodialysis patients, peritoneal dialysis patients, CKD patients, heart failure patients with and without renal dysfunction, and healthy controls. The research aims to explore the relationship between sodium deposition and uremic symptoms, as well as biochemical markers of metabolism. Participants will undergo one study visit, with the possibility of up to two follow-up visits.
Who should consider this trial
Good fit: Ideal candidates include patients aged 6 years and older with chronic kidney disease stages 1-5, those on maintenance hemodialysis or peritoneal dialysis, heart failure patients, and healthy controls.
Not a fit: Patients who are pregnant, breastfeeding, or unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of sodium's role in inflammation and uremic symptoms, potentially leading to improved management strategies for kidney disease patients.
How similar studies have performed: This study is novel as there have been no prior investigations into sodium deposition in the specified tissues of patients with varying kidney function and renal replacement therapy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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): * 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) Exclusion Criteria: * Pregnant, breastfeeding or intending pregnancy * Unable to give consent or understand written information * Contraindication to MRI study
Where this trial is running
London, Ontario
- LHSC Regional Renal Care Program — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Christopher W McIntyre, PhD, MD — Western University, Canada
- Study coordinator: Christopher W McIntyre, PhD, MD
- Email: christopher.mcintyre@lhsc.on.ca
- Phone: 519-685-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.