Validation of Renal Perfusion CEUS Against MRI, and Its Application in Acute Kidney Injury

NCT ID: NCT04181281

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2023-04-30

Brief 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. 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.

Conditions

Kidney Injury, Acute; Perfusion Imaging; Ultrasonography; Kidney Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

young adult

18 - 40 years old (n=10) Healthy male or female and able to give informed, written consent.

Contrast enhanced ultrasound

Intervention Type: DIAGNOSTIC_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 Imaging

Intervention Type: DIAGNOSTIC_TEST

Arterial spin labelling is an MRI technique allow for measuring tissue perfusion. It uses magnetically labelled arterial blood water protons as a tracer.

older adult

70 years or older (n=10) Healthy male or female and able to give informed, written consent.

Contrast enhanced ultrasound

Intervention Type: DIAGNOSTIC_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 Imaging

Intervention Type: DIAGNOSTIC_TEST

Arterial spin labelling is an MRI technique allow for measuring tissue perfusion. It uses magnetically labelled arterial blood water protons as a tracer.

AKI patients

Admitted patients with AKI stage 3

No interventions assigned to this group

Interventions

Contrast enhanced ultrasound

This is a regular ultrasound scanner used with an ultrasound contrast agent injected through veins to allow for kidney perfusion acquisition.

Intervention Type: DIAGNOSTIC_TEST

Arterial Spin Labelling -Magnetic Resonance Imaging

Arterial spin labelling is an MRI technique allow for measuring tissue perfusion. It uses magnetically labelled arterial blood water protons as a tracer.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

ASL-MRI

Eligibility Criteria

Inclusion Criteria

• Healthy male or female aged 18 years or older and able to give informed, written consent.

AKI stage 3 (as per KDIGO criteria).

Exclusion Criteria

• 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):

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nick Selby

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

University of Nottingham

Derby, , United Kingdom

Countries

United Kingdom

Central Contacts

Shatha J Almushayt, PhD

Role: CONTACT

mzxsa10@nottingham.ac.uk

+447575224296

Nick Selby

Role: CONTACT

nick.selby@nhs.net

01332 724665

Facility Contacts

Shatha J Almushayt

Role: primary

mzxsa10@nottingham.ac.uk

07575224296

References

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.

Reference Type: BACKGROUND

PMID: 30137581 (View on PubMed)

Liss 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.

Reference Type: BACKGROUND

PMID: 23252679 (View on PubMed)

Cox 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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 28168868 (View on PubMed)

Arthuis 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.

Reference Type: BACKGROUND

PMID: 30213488 (View on PubMed)

Hulley SB, Cummings SR, Browner WS, Grady D, Newman TB. Designing clinical research : an epidemiologic approach. 4th ed ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2013.

Reference Type: BACKGROUND

Other Identifiers

Renal CEUS against ASL-MRI

Identifier Type: -

Identifier Source: org_study_id