Clinical trial NCT04594291: MRI Changes of Acute Kidney Injury in COVID-19
Official title: Long-term Outcomes After Acute Kidney Injury in Coronavirus Disease (COVID-19) as Determined by Multiparametric Magnetic Resonance Imaging (MRI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Nottingham Biomedical Research Centre
First posted: 2020-10-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who have had COVID-19, were admitted to hospital, required intensive care, and/or developed AKI during their hospital stay.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients aged 18 years or older.
2. Swab result positive for SARS-CoV-2.
3. Patients admitted to the hospital for ≥24 hrs.
4. Patients who received ICU care OR who sustained AKI stage 2/3 (as per KDIGO serum creatinine criteria).

Exclusion Criteria:

1. Patients \> 90 years of age.
2. Patients on haemodialysis or peritoneal dialysis or pre-existing CKD stage 5 (eGFR \<15ml/min/1.73m2).
3. Solid organ transplant.
4. Inability/refusal to give informed consent to participate.
5. Contraindications to MRI scan - claustrophobia, metal body implants, extensive tatoos, inability to lie supine for 1 hour.

Primary outcomes:
measure: MRI assessment of global organ structure at 12 months.
timeFrame: 12 months
measure: MRI assessment of thrombi (R2*) at 12 months.
timeFrame: 12 months
measure: MRI assessment of organ perfusion (Arterial spin labelling [ASL]) at 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: MRI assessment of global organ structure.
timeFrame: 3-6 and 24 months
measure: MRI assessment of thrombi (R2*).
timeFrame: 3-6 and 24 months
measure: MRI assessment of organ perfusion (ASL)
timeFrame: 3-6 and 24 months
measure: Correlations between MRI measures with estimated glomerular filtration rate.
timeFrame: 3-6, 12 and 24 months
measure: Correlations between MRI measures with urine albumin and protein creatinine ratios.
timeFrame: 3-6, 12 and 24 months
measure: Correlations between MRI measures with mental component score.
timeFrame: 3-6, 12 and 24 months
measure: Correlations between MRI measures with physical component score.
timeFrame: 3-6, 12 and 24 months
measure: Correlations between MRI measures with health state score.
timeFrame: 3-6, 12 and 24 months
measure: Correlations between MRI measures with visual analogue score.
timeFrame: 3-6, 12 and 24 months
measure: Correlations between MRI measures with fatigue severity.
timeFrame: 3-6, 12 and 24 months
measure: Correlations between MRI measures with fatigue score.
timeFrame: 3-6, 12 and 24 months
measure: Correlations with MRI measures with skin autofluorescence levels.
timeFrame: 3-6, 12 and 24 months
measure: Mean change in mental component score.
timeFrame: 3-6, 12 and 24 months
measure: Mean change in physical component score.
timeFrame: 3-6, 12 and 24 months
measure: Mean change in health state score.
timeFrame: 3-6, 12 and 24 months
measure: Mean change in visual analogue score.
timeFrame: 3-6, 12 and 24 months
measure: Mean change in fatigue severity scale.
timeFrame: 3-6, 12 and 24 months
measure: Mean change in fatigue score.
timeFrame: 3-6, 12 and 24 months
measure: Mean change in skin autofluorescence levels.
timeFrame: 3-6, 12 and 24 months
measure: Incidence of kidney disease progression.
timeFrame: 3-6, 12 and 24 months
measure: Incidence of cardiovascular events.
timeFrame: 3-6, 12 and 24 months
measure: Correlations between MRI measures with all-cause mortality.
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: University Hospitals of Derby and Burton NHS Foundation Trust
state: Derbyshire
Study officials:
affiliation: University Hospitals of Derby and Burton NHS Foundation Trust
name: Maarten Taal, Professor
role: PRINCIPAL_INVESTIGATOR
References: