Kidney Sodium Functional Imaging
- Conditions
- NephrolithiasisADPKDChronic Kidney Disease
- Interventions
- Diagnostic Test: Sodium-23 MRI
- Registration Number
- NCT05014178
- Lead Sponsor
- London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
- Brief Summary
The corticomedullary gradient is largely responsible for developing the gradients that are needed to concentrate urine (more solutes and less water). The ability of the kidneys to produce concentrated urine is a major determinant of the ability to survive the warm weather. When temperatures are high, we lose water through sweat, and so the kidneys retain water to maintain fluidity in the blood. The maintenance of a sodium (salt) gradient is required for urine concentration because increased medullary sodium concentration increases the reabsorption of water into the kidney, to be redistributed in the blood. The purpose of this study is to know if the corticomedullary gradient is altered in patients across a wide spectrum of kidney disease using sodium Magnetic Resonance Imaging (MRI), a machine that takes pictures and measures the salt content in the kidneys. 23Na kidney MRI, will provide functional MR of the kidney as a non-invasive tool to describe medullary function to improve management of chronic and kidney disease.
- Detailed Description
This study is a pilot exploratory study (preliminary project to assess the use of a kidney sodium coil across a wide spectrum of kidney disease). Approximately 200 patients from the London Health Sciences Regional Renal Program will be recruited. This study involves two visits at Robarts Research Institute or St. Joseph's Hospital, London, Ontario depending on scanner availability, lasting approximately 2 hours.
At the first study visit participants will undergo a sodium MRI scan of your kidneys. Prior to the scan, participants will have their sitting blood pressure and heart rate measured three times consecutively using a standard automatic blood pressure monitor. In addition to this, participants will be asked to provide a spot urine sample and have blood work done. If participants have been treated for nephrolithiasis, they will be responsible for completing a 24-hour urine volume test sometime the week before the MRI scan.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Age ≥ 18 years
- For healthy controls: lack of kidney disease, heart failure, liver cirrhosis and peripheral edema
- For CKD stage 1-5: Estimated GFR < 90 mL/min/1.73m²
- For patients on maintenance hemodialysis or peritoneal dialysis: more than 3 months duration of therapy
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Pregnant, breastfeeding or intending pregnancy
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Contraindication to MRI
- Inability to tolerate MRI due to patient size and/or known history of claustrophobia.
- Mechanically implanted, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, tattoos, shunt, surgical staples (including clips or metallic sutures and/or ear implants.)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adult dialysis participants Sodium-23 MRI * Age greater than or equal to 18 years * More than 3 months duration of therapy Adult transplanted participants Sodium-23 MRI • Age greater than or equal to 18 years Adult CKD stage 1-5 participants Sodium-23 MRI * Age greater than or equal to 18 years * Estimated GFR \< 90 mL/min/1.73m² Adult ADPKD Sodium-23 MRI • Age greater than or equal to 18 years Adults treated for nephrolithiasis Sodium-23 MRI • Age greater than or equal to 18 years Adult healthy controls including kidney donors Sodium-23 MRI * Age greater than or equal to 18 years * Lack of kidney disease, heart failure, liver cirrhosis and peripheral
- Primary Outcome Measures
Name Time Method Exploratory cortico-medullary gradient measurement Throughout study visit, on average 2 hours Exploratory cortico-medullary gradient measurement in a large range of kidney disease by measuring sodium medullary to cortex ratio with23Na kidney MRI in:
1) stage 1-5 CKD patients 2) transplanted patients 3) dialysis patients 4) ADPKD patients 5) nephrolithiasis patients (characteristically associated with salt loading) 6) healthy controls including kidney donors
- Secondary Outcome Measures
Name Time Method Renal Function Throughout study visit, on average 2 hours To evaluate the relationship between sodium medullary to cortex ratio and renal function
Native and transplanted kidney Throughout study visit, on average 2 hours To compare sodium medullary to cortex ratio between native kidney and transplanted kidney
Residual renal function Throughout study visit, on average 2 hours To evaluate sodium medullary to cortex ratio in dialysis patients and renal residual function
Kidney biopsy Throughout study visit, on average 2 hours To compare sodium medullary to cortex ratio between transplanted kidney and kidney biopsy
Urinary osmolarity Throughout study visit, on average 2 hours To evaluate the relationship between sodium medullary to cortex ratio and urinary osmolarity
Nephrolithiasis Throughout study visit, on average 2 hours To compare sodium medullary to cortex ratio between healthy control and patients who have nephrolithiasis
ADPKD Throughout study visit, on average 2 hours To evaluate the ability to measure sodium medullary to cortex ratio in autosomal dominant polycystic kidney disease
Clinical practice Throughout study visit, on average 2 hours To determinate if measurement of sodium medullary to cortex ratio measurement is meaningful in clinical practice
Trial Locations
- Locations (1)
Victoria Hospital, London Health Sciences Centre
🇨🇦London, Ontario, Canada