Long-term Outcomes After Acute Kidney Injury in Coronavirus Disease (COVID-19) as Determined by Multiparametric Magnetic Resonance Imaging (MRI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- MRI assessment of thrombi (R2*) at 12 months.
研究概览
简要总结
This is a prospective observational cohort study that will aim to recruit 60 participants who have had COVID-19, were admitted to hospital, required intensive care, and/or developed AKI during their hospital stay. Potential participants will be approached either by telephone by a member of the research team or via clinics (nephrology, post-ICU follow up clinics).
详细描述
After the participants have read and understand the Participant Information Sheet, and had sufficient time (at least 24 hours) to consider their participation in this study, the investigators will ask them to sign a consent form, which shows their willingness to take part. The investigators will then collect information from their medical records about their hospital admission with COVID-19, including their age, ethnicity, medical conditions, length of hospital stay, tablets or any other treatments they received, as well as details of their stay in the ICU. The investigators will also arrange their first study visit which should be 3-6 months after they had been discharged from the hospital. During this first study day, the investigators will:
- Measure weight and height and take blood pressure.
- Take blood and urine samples.
- Ask participants to complete three questionnaires about their health, symptoms of fatigue and quality of life (SF-36, EQ-5D-5L and Fatigue Questionnaires).
- Measure the accumulation of toxins in the skin using a safe, quick (less than five minutes) and painless technique called skin autofluorescence. This involves placing the forearm on a piece of equipment that shines a light on the skin and measures the amount of light that is reflected back.
- Conduct an MRI scan of the kidneys, muscles, abdomen and heart. The MRI scan will take 60-70 minutes in total. The investigators will ask participants not to eat or drink anything two hours before the MRI scan.
After this visit, the investigators will ask participants to come back for two more study visits, which will be arranged at 12 and 24 months after their hospital discharge. These visits will consist of the same procedures and measurements done in the first study visit.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or older.
- •Swab result positive for SARS-CoV-
- •Patients admitted to the hospital for ≥24 hrs.
- •Patients who received ICU care OR who sustained AKI stage 2/3 (as per KDIGO serum creatinine criteria).
排除标准
- •Patients > 90 years of age.
- •Patients on haemodialysis or peritoneal dialysis or pre-existing CKD stage 5 (eGFR <15ml/min/1.73m2).
- •Solid organ transplant.
- •Inability/refusal to give informed consent to participate.
- •Contraindications to MRI scan - claustrophobia, metal body implants, extensive tatoos, inability to lie supine for 1 hour.
结局指标
主要结局
MRI assessment of thrombi (R2*) at 12 months.
时间窗: 12 months
R2\* data will be acquired using a multi-echo fast field echo (mFFE) scheme to assess thrombi. Conventionally R2\* mapping is used as a measure of oxygenation, but R2\*is likely to be altered by other factors in COVID-19, including oedema and small vessel thrombotic processes.
MRI assessment of global organ structure at 12 months.
时间窗: 12 months
Global organ structure will be assessed through structural T1- and T2-weighted MRI scans which will provide information about automated segmentation and volume assessment of whole kidney (and both cortex and medulla) as well as other abdominal organs (including liver and spleen). Global organ structure will also be assessed through longitudinal (T1) and transverse (T2) relaxation time mapping. T1 and T2 increase with tissue inflammation, oedema and fibrosis. A respiratory-triggered inversion recovery (IR) spin-echo echo-planar scheme will be used for abdominal T1 mapping and a Gradient and spin echo (T2-GraSE) scheme for abdominal T2 mapping.
MRI assessment of organ perfusion (Arterial spin labelling [ASL]) at 12 months.
时间窗: 12 months
Mean transit time and perfusion depicting changes in microvascular blood flow and large vessel flow/thrombosis will be determined using a FAIR labelling scheme with a multi-slice spin-echo echo-planar imaging readout and multiple labelling delay times.
次要结局
- Correlations between MRI measures with urine albumin and protein creatinine ratios.(3-6, 12 and 24 months)
- Correlations between MRI measures with physical component score.(3-6, 12 and 24 months)
- MRI assessment of global organ structure.(3-6 and 24 months)
- Mean change in fatigue score.(3-6, 12 and 24 months)
- Incidence of cardiovascular events.(3-6, 12 and 24 months)
- Correlations between MRI measures with estimated glomerular filtration rate.(3-6, 12 and 24 months)
- Correlations between MRI measures with mental component score.(3-6, 12 and 24 months)
- Correlations with MRI measures with skin autofluorescence levels.(3-6, 12 and 24 months)
- MRI assessment of thrombi (R2*).(3-6 and 24 months)
- MRI assessment of organ perfusion (ASL)(3-6 and 24 months)
- Correlations between MRI measures with health state score.(3-6, 12 and 24 months)
- Correlations between MRI measures with visual analogue score.(3-6, 12 and 24 months)
- Correlations between MRI measures with fatigue severity.(3-6, 12 and 24 months)
- Mean change in visual analogue score.(3-6, 12 and 24 months)
- Mean change in fatigue severity scale.(3-6, 12 and 24 months)
- Correlations between MRI measures with fatigue score.(3-6, 12 and 24 months)
- Mean change in physical component score.(3-6, 12 and 24 months)
- Mean change in health state score.(3-6, 12 and 24 months)
- Mean change in mental component score.(3-6, 12 and 24 months)
- Incidence of kidney disease progression.(3-6, 12 and 24 months)
- Mean change in skin autofluorescence levels.(3-6, 12 and 24 months)
- Correlations between MRI measures with all-cause mortality.(12 and 24 months)