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

February 15, 2021 updated by: University of Nottingham

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy Volunteers

Description

Stage1(healthy volunteers)

Inclusion Criteria:

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

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):

Inclusion criteria:

AKI stage 3 (as per KDIGO criteria).

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
young adult
18 - 40 years old (n=10) Healthy male or female and able to give informed, written consent.
Diagnostic test: Contrast enhanced ultrasound
This is a regular ultrasound scanner used with an ultrasound contrast agent injected through veins to allow for kidney perfusion acquisition.
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.
Other Names:
  • ASL-MRI
older adult
70 years or older (n=10) Healthy male or female and able to give informed, written consent.
Diagnostic test: Contrast enhanced ultrasound
This is a regular ultrasound scanner used with an ultrasound contrast agent injected through veins to allow for kidney perfusion acquisition.
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.
Other Names:
  • ASL-MRI
AKI patients
Admitted patients with AKI stage 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one week, ideally 1 day.
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.
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CEUS Repeatability
Time Frame: 1 day
Intra-individual reproducibility of the CEUS measures will be assessed by taking at least two measures in each individual to calculate coefficient of variation.
1 day
Correlation between global perfusion from PC-MRI corrected flow measures and CEUS
Time Frame: 1 week
Correlation between global perfusion from Phase contrast magnetic resonance Imaging corrected flow measures and CEUS
1 week
Correlation between kinetic time-intensity parameters of CEUS and time-resolved MRA
Time Frame: 1 week
Correlation between kinetic time-intensity parameters of CEUS and time-resolved Magnetic Resonance Angiography
1 week
Comparison of CEUS measures with daily serum creatinine (severity and recovery of AKI)
Time Frame: up to 3 months
Comparison of CEUS measures with daily serum creatinine (severity and recovery of AKI) renal recovery at day 90.
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
Nadir CEUS measures of renal microvascular blood flow in those with and without complete renal recovery at day 90.
up to 3 months
Relationship of CEUS measures with clinical measures.
Time Frame: up to 3 months
Relationship of CEUS measures with clinical measures including blood pressure, urine output.
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: Nick Selby, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

November 26, 2019

First Posted (Actual)

November 29, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Renal CEUS against ASL-MRI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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