NCT04181281

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

November 26, 2019

Last Update Submit

February 15, 2021

Conditions

Kidney Injury, AcutePerfusion ImagingUltrasonographyKidney Diseases

Keywords

CEUSMRIkidney perfusionacute kidney disease

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    up to 3 months

Secondary Outcomes (6)

  • CEUS Repeatability

    1 day

  • Correlation between global perfusion from PC-MRI corrected flow measures and CEUS

    1 week

  • Correlation between kinetic time-intensity parameters of CEUS and time-resolved MRA

    1 week

  • Comparison of CEUS measures with daily serum creatinine (severity and recovery of AKI)

    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

  • +1 more secondary outcomes

Study Arms (3)

young adult

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

Diagnostic Test: Contrast enhanced ultrasoundDiagnostic 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.

Diagnostic Test: Contrast enhanced ultrasoundDiagnostic Test: Arterial Spin Labelling -Magnetic Resonance Imaging

AKI patients

Admitted patients with AKI stage 3

Interventions

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.

older adultyoung adult
Arterial Spin Labelling -Magnetic Resonance ImagingDIAGNOSTIC_TEST

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

Also known as: ASL-MRI
older adultyoung adult

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy Volunteers

You may qualify if:

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

You may not qualify if:

  • 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):
  • AKI stage 3 (as per KDIGO 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Derby, DE22 3NE, United Kingdom

Location

Related Publications (6)

  • 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.

    PMID: 30137581BACKGROUND

  • 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.

    PMID: 23252679BACKGROUND

  • 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.

    PMID: 28959212BACKGROUND

  • Heinink 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.

    PMID: 28168868BACKGROUND

  • 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.

    PMID: 30213488BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Acute Kidney InjuryKidney Diseases

Condition Hierarchy (Ancestors)

Renal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Nick Selby

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shatha J Almushayt, PhD

CONTACT

+447575224296mzxsa10@nottingham.ac.uk

Nick Selby

CONTACT

01332 724665nick.selby@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

November 29, 2019

Study Start

April 1, 2021

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations

GB(1)