Kidney Sodium Functional Imaging: Evaluation of Kidney Medullary Sodium Content Using 23Na MRI in Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Exploratory cortico-medullary gradient measurement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Pregnant, breastfeeding or intending pregnancy
- •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.)
结局指标
主要结局
Exploratory cortico-medullary gradient measurement
时间窗: 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
次要结局
- Renal Function(Throughout study visit, on average 2 hours)
- Native and transplanted kidney(Throughout study visit, on average 2 hours)
- Residual renal function(Throughout study visit, on average 2 hours)
- Kidney biopsy(Throughout study visit, on average 2 hours)
- Urinary osmolarity(Throughout study visit, on average 2 hours)
- Nephrolithiasis(Throughout study visit, on average 2 hours)
- ADPKD(Throughout study visit, on average 2 hours)
- Clinical practice(Throughout study visit, on average 2 hours)
研究者
Chris McIntyre
Nephrologist
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's