Acute Kidney InjuryMRI-AIDEDNCT04594291
MRI Changes of Acute Kidney Injury in COVID-19
An observational study of Acute Kidney Injury, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- MRI scans
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Oct 2020to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People who have had COVID-19, were admitted to hospital, required intensive care, and/or developed AKI during their hospital stay.
Who may be able to join
- Adult patients aged 18 years or older.
- Swab result positive for SARS-CoV-2.
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, Derbyshire, DE22 3DT
About this study
Official title: Long-term Outcomes After Acute Kidney Injury in Coronavirus Disease (COVID-19) as Determined by Multiparametric Magnetic Resonance Imaging (MRI)
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).
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- MRI scans
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scansProcedure or surgery
This study does not involve any intervention or new treatment. We will conduct MRI scans of the kidneys, muscles, abdomen and heart at baseline, 12 and 24 months after hospital discharge. The MRI scan will take 60-70 minutes in total.
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI assessment of global organ structure at 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.
Measured: 12 months
MRI assessment of thrombi (R2*) at 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.
Measured: 12 months
MRI assessment of organ perfusion (Arterial spin labelling [ASL]) at 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.
Measured: 12 months
Secondary outcomes (22)
MRI assessment of global organ structure.
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.
Measured: 3-6 and 24 months
MRI assessment of thrombi (R2*).
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.
Measured: 3-6 and 24 months
MRI assessment of organ perfusion (ASL)
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.
Measured: 3-6 and 24 months
Correlations between MRI measures with estimated glomerular filtration rate.
Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with estimated glomerular filtration rate (ml/min/1.73m2).
Measured: 3-6, 12 and 24 months
Correlations between MRI measures with urine albumin and protein creatinine ratios.
Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with urine albumin creatinine ratio (mg/mmol) and urine protein creatinine ratio (mg/mmol).
Measured: 3-6, 12 and 24 months
Correlations between MRI measures with mental component score.
Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the mental component score. A score between 0 and 100 is calculated from the 36-Item Short-Form Health Survey; the higher the score, the better the quality of life mental domain.
Measured: 3-6, 12 and 24 months
Correlations between MRI measures with physical component score.
Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the physical component score. A score between 0 and 100 is calculated from the 36-Item Short-Form Health Survey; the higher the score, the better the quality of life physical domain.
Measured: 3-6, 12 and 24 months
Correlations between MRI measures with health state score.
Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the health state score calculated from the European Quality of Life 5-Dimensions questionnaire. The health state score ranges from -0.285 (for the worst health state) to 1 (for the best health state).
Measured: 3-6, 12 and 24 months
Correlations between MRI measures with visual analogue score.
Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the visual analogue score from the European Quality of Life 5-Dimensions questionnaire. The visual analogue score uses a thermometer-like scale numbered from 0 to 100; the higher the score, the better the health state.
Measured: 3-6, 12 and 24 months
Correlations between MRI measures with fatigue severity.
Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the fatigue score from the Fatigue Severity Scale, a 9-item questionnaire scored on a 7-point scale (minimum score=9; maximum score=63); the higher the score, the greater the fatigue severity.
Measured: 3-6, 12 and 24 months
Correlations between MRI measures with fatigue score.
Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the fatigue score from the Visual Analogue Fatigue Scale, which uses an horizontal line scale numbered from 0 to 10; the higher the score, the higher the fatigue.
Measured: 3-6, 12 and 24 months
Correlations with MRI measures with skin autofluorescence levels.
Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with skin autofluorescence levels (arbitrary units) measured with the validated Autofluorescence Reader Standard Unit (SU) version 2.4.3 (AGE Reader SU, DiagnOptics Technologies BV, Aarhusweg 4-9, Groningen, The Netherlands).
Measured: 3-6, 12 and 24 months
Mean change in mental component score.
Mean change in mental component score. A score between 0 and 100 is calculated from the 36-Item Short-Form Health Survey; the higher the score, the better the quality of life mental domain.
Measured: 3-6, 12 and 24 months
Mean change in physical component score.
Mean change in physical component score. A score between 0 and 100 is calculated from the 36-Item Short-Form Health Survey; the higher the score, the better the quality of life physical domain.
Measured: 3-6, 12 and 24 months
Mean change in health state score.
Mean change in health state score calculated from the European Quality of Life 5-Dimensions questionnaire. The health state score ranges from -0.285 (for the worst health state) to 1 (for the best health state).
Measured: 3-6, 12 and 24 months
Mean change in visual analogue score.
Mean change in visual analogue score from the European Quality of Life 5-Dimensions questionnaire. The visual analogue score uses a thermometer-like scale numbered from 0 to 100; the higher the score, the better the health state.
Measured: 3-6, 12 and 24 months
Mean change in fatigue severity scale.
Mean change in fatigue score as assessed by the Fatigue Severity Scale, a 9-item questionnaire scored on a 7-point scale (minimum score=9; maximum score=63); the higher the score, the greater the fatigue severity.
Measured: 3-6, 12 and 24 months
Mean change in fatigue score.
Mean change in fatigue score as assessed by the Visual Analogue Fatigue Scale, which uses an horizontal line scale numbered from 0 to 10; the higher the score, the higher the fatigue.
Measured: 3-6, 12 and 24 months
Mean change in skin autofluorescence levels.
Mean change in skin autofluorescence levels (arbitrary units) measured with the AGE Reader.
Measured: 3-6, 12 and 24 months
Incidence of kidney disease progression.
Assessment of kidney disease progression defined as decrease in estimated glomerular filtration rate (eGFR) of ≥25% associated with a decline in eGFR stage.
Measured: 3-6, 12 and 24 months
Incidence of cardiovascular events.
Recording of the number of participants who developed any cardiovascular events.
Measured: 3-6, 12 and 24 months
Correlations between MRI measures with all-cause mortality.
Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with all-cause mortality using multi-variable Cox proportional hazards models.
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start7 Oct 2020
- Primary completion25 Mar 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham Biomedical Research Centre
- Responsible party
- Sponsor
- Investigators
- Maarten Taal, Professor, Principal investigator, University Hospitals of Derby and Burton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594291
- Sponsor's protocol ID
- UHDB/2020/077
- Other IDs
- 287571
- Acronym
- MRI-AIDED
- Status last verified
- Nov 2023
- First submitted
- 28 Sep 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes After Acute Kidney Injury in Coronavirus Disease (COVID-19) as Determined by Multiparametric Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT04594291
- Acronym / sponsor ID
- MRI-AIDED / UHDB/2020/077
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Nottingham Biomedical Research Centre
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who have had COVID-19, were admitted to hospital, required intensive care, and/or developed AKI during their hospital stay.
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older.
- Swab result positive for SARS-CoV-2.
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scansThis study does not involve any intervention or new treatment. We will conduct MRI scans of the kidneys, muscles, abdomen and heart at baseline, 12 and 24 months after hospital discharge. The MRI scan will take 60-70 minutes in total. | Procedure or surgery | – |
Primary outcome
MRI assessment of global organ structure at 12 months.
Time frame: 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 thrombi (R2*) at 12 months.
Time frame: 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 organ perfusion (Arterial spin labelling [ASL]) at 12 months.
Time frame: 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.
22 secondary outcomes
MRI assessment of global organ structure.
Time frame: 3-6 and 24 months
MRI assessment of thrombi (R2*).
Time frame: 3-6 and 24 months
MRI assessment of organ perfusion (ASL)
Time frame: 3-6 and 24 months
Correlations between MRI measures with estimated glomerular filtration rate.
Time frame: 3-6, 12 and 24 months
Correlations between MRI measures with urine albumin and protein creatinine ratios.
Time frame: 3-6, 12 and 24 months
Correlations between MRI measures with mental component score.
Time frame: 3-6, 12 and 24 months
Correlations between MRI measures with physical component score.
Time frame: 3-6, 12 and 24 months
Correlations between MRI measures with health state score.
Time frame: 3-6, 12 and 24 months
Correlations between MRI measures with visual analogue score.
Time frame: 3-6, 12 and 24 months
Correlations between MRI measures with fatigue severity.
Time frame: 3-6, 12 and 24 months
Correlations between MRI measures with fatigue score.
Time frame: 3-6, 12 and 24 months
Correlations with MRI measures with skin autofluorescence levels.
Time frame: 3-6, 12 and 24 months
Mean change in mental component score.
Time frame: 3-6, 12 and 24 months
Mean change in physical component score.
Time frame: 3-6, 12 and 24 months
Mean change in health state score.
Time frame: 3-6, 12 and 24 months
Mean change in visual analogue score.
Time frame: 3-6, 12 and 24 months
Mean change in fatigue severity scale.
Time frame: 3-6, 12 and 24 months
Mean change in fatigue score.
Time frame: 3-6, 12 and 24 months
Mean change in skin autofluorescence levels.
Time frame: 3-6, 12 and 24 months
Incidence of kidney disease progression.
Time frame: 3-6, 12 and 24 months
Incidence of cardiovascular events.
Time frame: 3-6, 12 and 24 months
Correlations between MRI measures with all-cause mortality.
Time frame: 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten Taal, Professor principal investigator
University Hospitals of Derby and Burton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI assessment of global organ structure at 12 months. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.