Using MRI ASL Techniques for Quantitative Measurement of Renal Haemodynamics and Structural Parameters in Acute Kidney Injury and Chronic Kidney Disease.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The difference between T1 (ms) MR parameter between healthy volunteers and patients with CKD and AKI
研究概览
简要总结
To use Non-invasive MR Imaging of Renal Physiology and structure to assess patients with Acute Kidney Injury (AKI) and Chronic Kidney Disease (CKD).
详细描述
Multi centre observational pilot study using novel, contrast free functional renal MRI scans.
A series of functional renal MRI scans will be performed (These scans do not constitute part patients routine clinical care). The results will initially be used to assess renal perfusion and fibrosis in patients with AKI and CKD. Subsequent analysis will be used to identify specific markers on the renal MRI scans that differentiate chronic kidney damage from acute injury to the kidney. Finally results will be used to stratify patients with AKI and CKD into low and high risk of subsequent deterioration in renal function.
AKI Cohort
25 patients with AKI stage 2/3 with or without renal replacement therapy (RRT) will undergo functional renal MRI imaging at day 0, day 90 and day 365.
First Study Scan (Day 0): A functional renal MRI scan will be performed during an admission to hospital with an episode of AKI 2/3. Vital signs and SOFA score will be recorded on the day of the scan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AKI Patients:
- •Acute Kidney Injury stage 2/3 (duration >24 hours) including patients requiring renal replacement therapy
- •>18 years & < 95 years
- •Able to give informed consent
- •CKD Patients:
- •Patients with CKD Stage 3 - 4 (e GFR> 20 and <60 ml/min)
- •>18 years & < 95 years
- •Able to give informed consent
排除标准
- •AKI Patients:
- •Renal transplant
- •Contraindications to MRI e.g. claustrophobia, cardiac pacemaker, metallic fragments or implants
- •Pregnancy or breast feeding or intending pregnancy
- •Unable to give consent or understand written information
- •Pre-existing CKD of any stage as per eGFR
- •Obstructive uropathy
- •AKI duration <24hrs, in the opinion of the investigator
- •Not medically fit for transfer to MRI scan, in the opinion of the clinical team or the investigator
- •Iodine allergy
- •Patients unable to comply with basic verbal English commands whilst in scanner due to special communication needs
- •CKD Patients:
- •Renal transplant
- •Contraindications to MRI e.g. claustrophobia, cardiac pacemaker, metallic fragments or implants
- •Pregnancy or breast feeding or intending pregnancy
- •Unable to give consent or understand written information
- •Unstable CKD; AKI Stage 1 or more or other unplanned hospital admission within the last 90 days
- •Iodine allergy
- •Patients unable to comply with basic verbal English commands whilst in scanner due to special communication needs
结局指标
主要结局
The difference between T1 (ms) MR parameter between healthy volunteers and patients with CKD and AKI
时间窗: 3 years
Examining the difference in T1 (ms) between the 3 groups using PRISM, SPSS, Stata and Matlab
The difference between volume (mls) MR parameter between healthy volunteers and patients with CKD and AKI
时间窗: 3 years
Examining the difference in volume (mls) T1 (ms) between the 3 groups using PRISM, SPSS, Stata and Matlab
The difference between Diffusion weighted imaging MR parameter between healthy volunteers and patients with CKD and AKI
时间窗: 3 years
Examining the difference in ADC and D(ms) between the 3 groups using PRISM, SPSS, Stata and Matlab
次要结局
- Correlations between structural MR measurement: T1(ms) and creatinine(µmols),(3 years)
- Correlations between structural T1 (ms) and blinded renal biopsy measurements(3 years)
- Correlations between structural diffusion weighted imaging and blinded renal biopsy measurements(3 years)
- Correlations between structural MR measurement: diffusion weighted imaging and eGFR mls/min.1.73m(3 years)