Sodium Accumulation Study In Haemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Ascertainment of MRI measures of skin sodium content in 100% of patients studied
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Active infection or malignancy
- •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
结局指标
主要结局
Ascertainment of MRI measures of skin sodium content in 100% of patients studied
时间窗: 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
时间窗: 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.
次要结局
- To measure degree of change in muscle sodium content in relation to a single haemodialysis treatment(6 months)
- To study skin sodium in haemodialysis patients and compare with previously reported healthy normal values(6 months)
- To study muscle sodium in haemodialysis patients and compare with previously reported healthy normal values(6 months)
- To measure degree of change in skin sodium content in relation to a single haemodialysis treatment(6 months)
研究者
Nicholas Selby
Professor of Nephrology
University Hospitals of Derby and Burton NHS Foundation Trust