Kidney Injury, AcuteNCT04181281
Validation of Renal Perfusion CEUS Against MRI, and Its Application in Acute Kidney Injury
An observational study of Kidney Injury, Acute and Perfusion Imaging, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The purposes of this study is 1. To establish the validity of CEUS to measure renal perfusion by comparing it against ASL-MRI in young and older healthy volunteers, and generate a normative dataset of CEUS measures of renal perfusion. 2. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Injury, Acute, Perfusion Imaging, Ultrasonography
- What is being tested?
- Contrast enhanced ultrasound and Arterial Spin Labelling -Magnetic Resonance Imaging
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2021to Apr 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers
Who may be able to join
- Healthy male or female aged 18 years or older and able to give informed, written consent.
- AKI stage 3 (as per KDIGO criteria).
Who cannot join
- estimated Globular Filtration Rate (eGFR) <60ml/min or albuminuria
- Diabetes
- Prescription of anti-hypertensive agents that alter renal haemodynamics (renal angiotensin
- Known allergy to SonoVue contrast agent
- Contraindications to MRI
- Stage2 (AKI group):
Show all 13Show fewer
- autosomal dominant polycystic kidney disease
- glomerulonephritis receiving immunosuppression
- multiple myeloma
- obstructive uropathy
- solid organ transplant
- known allergy to Sonvue
- lack of baseline serum creatinine value within previous 365 days ->72hrs elapsed since detection of AKI
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Derby, DE22 3NE
Shatha J Almushayt, 07575224296, mzxsa10@nottingham.ac.uk
About this study
Official title: Validation of Contrast Enhanced Ultrasound (CEUS) for the Assessment of Renal Perfusion Using Renal Magnetic Resonance Imaging (MRI), and Its Application in Acute Kidney Injury (AKI)
The purposes of this study is 1. To establish the validity of CEUS to measure renal perfusion by comparing it against ASL-MRI in young and older healthy volunteers, and generate a normative dataset of CEUS measures of renal perfusion. 2. Establish proof of principle for the use of CEUS to measure renal perfusion in the acute phase of AKI, demonstrating its feasibility and potential clinical utility. We will do this by performing daily CEUS measurements for up to five days in a cohort of people with AKI stage 3, commencing as close to onset.
of AKI as possible, correlating with clinical data and following outcomes until 90 days.
Read the detailed description
Kidneys have an extremely high blood flow. A quarter of the blood that is pumped by the heart goes to the kidneys, and your entire blood volume passes through your kidneys forty times each day. Some of this blood flow is needed to keep the kidneys healthy by delivering oxygen and nutrients; this delivery of blood to the kidney is called 'perfusion'. We know that many forms of kidney disease involve a fall in kidney perfusion. In particular, reduced kidney perfusion is a common cause of a sudden reduction in kidney function, called Acute Kidney Injury (AKI). AKI is an extremely important problem, as people who sustain AKI are at higher risk of death, often remain in hospital for longer periods of time and sometimes experience long-term kidney damage. At the moment, there is no practical way to measure kidney perfusion in patients, and developing ways to do this would lead to ways to improve and individualise treatment.
We would like to perform a research project to test whether a new method of assessing kidney perfusion can improve care for people with AKI. A new type of ultrasound scan (contrast enhanced ultrasound, or CEUS) is available, and has a number of advantages. It is safe, does not involve radiation, and importantly for patients with AKI who are often very poorly, it can be performed at the bedside (so no need for patients to transfer to scanners). However, at the moment we do not know if CEUS is a reliable way to measure kidney perfusion.
Our research project has two stages. In the first stage, we will test whether CEUS can accurately measure renal perfusion. We will do that by comparing it with the gold standard method using MRI scanning in 20 healthy volunteers (10 young and 10 older volunteers), who will have both scans on the same day. Heathy volunteers have been chosen for two reasons: firstly, it would be too intrusive to ask patients with AKI to undergo two types of scanning on the same day; secondly using CEUS to measure renal perfusion in healthy volunteers will allow us to determine 'normal' values in younger and older people that will be useful as a comparison for future research. If CEUS proves to be a reasonable way to measure renal perfusion, we will then study if CEUS is useful in patients with AKI. We will perform CEUS in 30 patients who are in hospital and have severe AKI (stage 3 AKI). We will perform CEUS as soon as possible after the onset of AKI, and then take daily measurements for five days to determine if CEUS gives useful additional useful information in these patients. We will also compare CEUS measures with the degree to which patients' kidney function recovers at time of discharge from hospital, and then again three months later. Results from this research will pave the way for the future use of CEUS for the care of patients with kidney disease.
We would like to perform a study to test can measure kidney perfusion. We will do this by comparing CEUS with MRI scans which is the 'gold-standard' method of measuring kidney perfusion. If CEUS performs well, then this will allow future studies in which CEUS can be used to help patients with kidney disease.
- Being tested
- Contrast enhanced ultrasound, Arterial Spin Labelling -Magnetic Resonance Imaging
- Keywords
- CEUS, MRI, kidney perfusion, acute kidney disease
- Medical subject headings
- Acute Kidney Injury, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast enhanced ultrasoundDiagnostic test
This is a regular ultrasound scanner used with an ultrasound contrast agent injected through veins to allow for kidney perfusion acquisition.
Arterial Spin Labelling -Magnetic Resonance ImagingDiagnostic test
Also called ASL-MRI
Arterial spin labelling is an MRI technique allow for measuring tissue perfusion. It uses magnetically labelled arterial blood water protons as a tracer.
| Study group | Role | What they receive |
|---|---|---|
| young adult | 18 - 40 years old (n=10) Healthy male or female and able to give informed, written consent. Receives: Diagnostic Test: Contrast enhanced ultrasound; Diagnostic Test: Arterial Spin Labelling -Magnetic Resonance Imaging | |
| older adult | 70 years or older (n=10) Healthy male or female and able to give informed, written consent. Receives: Diagnostic Test: Contrast enhanced ultrasound; Diagnostic Test: Arterial Spin Labelling -Magnetic Resonance Imaging | |
| AKI patients | Admitted patients with AKI stage 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between ASL-MRI and CEUS measures of renal perfusion
The primary outcome will be the correlation between ASL-MRI measures of cortical perfusion (ml/ 100g/min) and CEUS measures of renal microvascular blood flow.
Measured: one week, ideally 1 day.
Renal blood flow in AKI patients
The primary outcome will be the mean and SD or median and IQR for renal microvascular blood flow on first assessment <72h after onset of AKI as assessed by CEUS.
Measured: up to 3 months
Secondary outcomes (6)
CEUS Repeatability
Intra-individual reproducibility of the CEUS measures will be assessed by taking at least two measures in each individual to calculate coefficient of variation.
Measured: 1 day
Correlation between global perfusion from PC-MRI corrected flow measures and CEUS
Correlation between global perfusion from Phase contrast magnetic resonance Imaging corrected flow measures and CEUS
Measured: 1 week
Correlation between kinetic time-intensity parameters of CEUS and time-resolved MRA
Correlation between kinetic time-intensity parameters of CEUS and time-resolved Magnetic Resonance Angiography
Measured: 1 week
Comparison of CEUS measures with daily serum creatinine (severity and recovery of AKI)
Comparison of CEUS measures with daily serum creatinine (severity and recovery of AKI) renal recovery at day 90.
Measured: up to 3 months
Nadir CEUS measures of renal microvascular blood flow in those with and without complete renal recovery at day 90.
Nadir CEUS measures of renal microvascular blood flow in those with and without complete renal recovery at day 90.
Measured: up to 3 months
Relationship of CEUS measures with clinical measures.
Relationship of CEUS measures with clinical measures including blood pressure, urine output.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study startApr 2021 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kidney Injury, AcuteStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Selby, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181281
- Sponsor's protocol ID
- Renal CEUS against ASL-MRI
- Status last verified
- Feb 2021
- First submitted
- 26 Nov 2019
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Odudu A, Nery F, Harteveld AA, Evans RG, Pendse D, Buchanan CE, Francis ST, Fernandez-Seara MA. Arterial spin labelling MRI to measure renal perfusion: a systematic review and statement paper. Nephrol Dial Transplant. 2018 Sep 1;33(suppl_2):ii15-ii21. doi: 10.1093/ndt/gfy180.
PubMed 30137581Liss P, Cox EF, Eckerbom P, Francis ST. Imaging of intrarenal haemodynamics and oxygen metabolism. Clin Exp Pharmacol Physiol. 2013 Feb;40(2):158-67. doi: 10.1111/1440-1681.12042.
PubMed 23252679Cox EF, Buchanan CE, Bradley CR, Prestwich B, Mahmoud H, Taal M, Selby NM, Francis ST. Multiparametric Renal Magnetic Resonance Imaging: Validation, Interventions, and Alterations in Chronic Kidney Disease. Front Physiol. 2017 Sep 14;8:696. doi: 10.3389/fphys.2017.00696. eCollection 2017.
PubMed 28959212Heinink TP, Read DJ, Mitchell WK, Bhalla A, Lund JN, Phillips BE, Williams JP. Oesophageal Doppler guided optimization of cardiac output does not increase visceral microvascular blood flow in healthy volunteers. Clin Physiol Funct Imaging. 2018 Mar;38(2):213-219. doi: 10.1111/cpf.12401. Epub 2017 Feb 6.
PubMed 28168868Arthuis CJ, Mendes V, Meme S, Meme W, Rousselot C, Winer N, Novell A, Perrotin F. Comparative determination of placental perfusion by magnetic resonance imaging and contrast-enhanced ultrasound in a murine model of intrauterine growth restriction. Placenta. 2018 Sep;69:74-81. doi: 10.1016/j.placenta.2018.07.009. Epub 2018 Jul 18.
PubMed 30213488Hulley SB, Cummings SR, Browner WS, Grady D, Newman TB. Designing clinical research : an epidemiologic approach. 4th ed ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2013.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Contrast Enhanced Ultrasound (CEUS) for the Assessment of Renal Perfusion Using Renal Magnetic Resonance Imaging (MRI), and Its Application in Acute Kidney Injury (AKI)
- ClinicalTrials.gov ID
- NCT04181281
- Acronym / sponsor ID
- Renal CEUS against ASL-MRI
- Keywords
- CEUS, MRI, kidney perfusion, acute kidney disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 29 Nov 2019 (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.
The purposes of this study is 1. To establish the validity of CEUS to measure renal perfusion by comparing it against ASL-MRI in young and older healthy volunteers, and generate a normative dataset of CEUS measures of renal perfusion. 2. Establish proof of principle for the use of CEUS to measure renal perfusion in the acute phase of AKI, demonstrating its feasibility and potential clinical utility. We will do this by performing daily CEUS measurements for up to five days in a cohort of people with AKI stage 3, commencing as close to onset.
of AKI as possible, correlating with clinical data and following outcomes until 90 days.
Detailed description
Kidneys have an extremely high blood flow. A quarter of the blood that is pumped by the heart goes to the kidneys, and your entire blood volume passes through your kidneys forty times each day. Some of this blood flow is needed to keep the kidneys healthy by delivering oxygen and nutrients; this delivery of blood to the kidney is called 'perfusion'. We know that many forms of kidney disease involve a fall in kidney perfusion. In particular, reduced kidney perfusion is a common cause of a sudden reduction in kidney function, called Acute Kidney Injury (AKI). AKI is an extremely important problem, as people who sustain AKI are at higher risk of death, often remain in hospital for longer periods of time and sometimes experience long-term kidney damage. At the moment, there is no practical way to measure kidney perfusion in patients, and developing ways to do this would lead to ways to improve and individualise treatment.
We would like to perform a research project to test whether a new method of assessing kidney perfusion can improve care for people with AKI. A new type of ultrasound scan (contrast enhanced ultrasound, or CEUS) is available, and has a number of advantages. It is safe, does not involve radiation, and importantly for patients with AKI who are often very poorly, it can be performed at the bedside (so no need for patients to transfer to scanners). However, at the moment we do not know if CEUS is a reliable way to measure kidney perfusion.
Our research project has two stages. In the first stage, we will test whether CEUS can accurately measure renal perfusion. We will do that by comparing it with the gold standard method using MRI scanning in 20 healthy volunteers (10 young and 10 older volunteers), who will have both scans on the same day. Heathy volunteers have been chosen for two reasons: firstly, it would be too intrusive to ask patients with AKI to undergo two types of scanning on the same day; secondly using CEUS to measure renal perfusion in healthy volunteers will allow us to determine 'normal' values in younger and older people that will be useful as a comparison for future research. If CEUS proves to be a reasonable way to measure renal perfusion, we will then study if CEUS is useful in patients with AKI. We will perform CEUS in 30 patients who are in hospital and have severe AKI (stage 3 AKI). We will perform CEUS as soon as possible after the onset of AKI, and then take daily measurements for five days to determine if CEUS gives useful additional useful information in these patients. We will also compare CEUS measures with the degree to which patients' kidney function recovers at time of discharge from hospital, and then again three months later. Results from this research will pave the way for the future use of CEUS for the care of patients with kidney disease.
We would like to perform a study to test can measure kidney perfusion. We will do this by comparing CEUS with MRI scans which is the 'gold-standard' method of measuring kidney perfusion. If CEUS performs well, then this will allow future studies in which CEUS can be used to help patients with kidney disease.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| young adult | – | Diagnostic Test: Contrast enhanced ultrasound, Diagnostic Test: Arterial Spin Labelling -Magnetic Resonance Imaging18 - 40 years old (n=10) Healthy male or female and able to give informed, written consent. |
| older adult | – | Diagnostic Test: Contrast enhanced ultrasound, Diagnostic Test: Arterial Spin Labelling -Magnetic Resonance Imaging70 years or older (n=10) Healthy male or female and able to give informed, written consent. |
| AKI patients | – | –Admitted patients with AKI stage 3 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers
Key inclusion criteria (2 listed)
- Healthy male or female aged 18 years or older and able to give informed, written consent.
- AKI stage 3 (as per KDIGO criteria).
Key exclusion criteria (13 listed)
- estimated Globular Filtration Rate (eGFR) <60ml/min or albuminuria
- autosomal dominant polycystic kidney disease
- glomerulonephritis receiving immunosuppression
- multiple myeloma
- obstructive uropathy
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 |
|---|---|---|
| Contrast enhanced ultrasoundThis is a regular ultrasound scanner used with an ultrasound contrast agent injected through veins to allow for kidney perfusion acquisition. | Diagnostic test | older adult, young adult |
| Arterial Spin Labelling -Magnetic Resonance ImagingAlso: ASL-MRIArterial spin labelling is an MRI technique allow for measuring tissue perfusion. It uses magnetically labelled arterial blood water protons as a tracer. | Diagnostic test | older adult, young adult |
Primary outcome
Correlation between ASL-MRI and CEUS measures of renal perfusion
Time frame: one week, ideally 1 day.
The primary outcome will be the correlation between ASL-MRI measures of cortical perfusion (ml/ 100g/min) and CEUS measures of renal microvascular blood flow.
Renal blood flow in AKI patients
Time frame: up to 3 months
The primary outcome will be the mean and SD or median and IQR for renal microvascular blood flow on first assessment <72h after onset of AKI as assessed by CEUS.
6 secondary outcomes
CEUS Repeatability
Time frame: 1 day
Correlation between global perfusion from PC-MRI corrected flow measures and CEUS
Time frame: 1 week
Correlation between kinetic time-intensity parameters of CEUS and time-resolved MRA
Time frame: 1 week
Comparison of CEUS measures with daily serum creatinine (severity and recovery of AKI)
Time frame: up to 3 months
Nadir CEUS measures of renal microvascular blood flow in those with and without complete renal recovery at day 90.
Time frame: up to 3 months
Relationship of CEUS measures with clinical measures.
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Background: PubMed 30137581Odudu A, Nery F, Harteveld AA, Evans RG, Pendse D, Buchanan CE, Francis ST, Fernandez-Seara MA. Arterial spin labelling MRI to measure renal perfusion: a systematic review and statement paper. Nephrol Dial Transplant. 2018 Sep 1;33(suppl_2):ii15-ii21. doi: 10.1093/ndt/gfy180.
- Background: PubMed 23252679Liss P, Cox EF, Eckerbom P, Francis ST. Imaging of intrarenal haemodynamics and oxygen metabolism. Clin Exp Pharmacol Physiol. 2013 Feb;40(2):158-67. doi: 10.1111/1440-1681.12042.
- Background: PubMed 28959212Cox EF, Buchanan CE, Bradley CR, Prestwich B, Mahmoud H, Taal M, Selby NM, Francis ST. Multiparametric Renal Magnetic Resonance Imaging: Validation, Interventions, and Alterations in Chronic Kidney Disease. Front Physiol. 2017 Sep 14;8:696. doi: 10.3389/fphys.2017.00696. eCollection 2017.
- Background: PubMed 28168868Heinink TP, Read DJ, Mitchell WK, Bhalla A, Lund JN, Phillips BE, Williams JP. Oesophageal Doppler guided optimization of cardiac output does not increase visceral microvascular blood flow in healthy volunteers. Clin Physiol Funct Imaging. 2018 Mar;38(2):213-219. doi: 10.1111/cpf.12401. Epub 2017 Feb 6.
- Background: PubMed 30213488Arthuis CJ, Mendes V, Meme S, Meme W, Rousselot C, Winer N, Novell A, Perrotin F. Comparative determination of placental perfusion by magnetic resonance imaging and contrast-enhanced ultrasound in a murine model of intrauterine growth restriction. Placenta. 2018 Sep;69:74-81. doi: 10.1016/j.placenta.2018.07.009. Epub 2018 Jul 18.
- BackgroundHulley SB, Cummings SR, Browner WS, Grady D, Newman TB. Designing clinical research : an epidemiologic approach. 4th ed ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2013.
- Individual participant dataSharing planned: Undecided
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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.
Nick Selby principal investigator
University of Nottingham
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 Kidney Injury, Acute and Perfusion Imaging, run by University of Nottingham 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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 17 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shatha J Almushayt, PhD (+447575224296, mzxsa10@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between ASL-MRI and CEUS measures of renal perfusion (time frame: one week, ideally 1 day.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04181281, which also lists 6 linked publications.
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 17 Feb 2021.