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NCT Number: NCT04144894

The Biosonographic Index

In this exploratory study we explore the use of Shear Wave Elastography to differentiate between Acute Kidney Injury after vascular surgery and among the healthy population.

Recruiting

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location status: Recruiting

Location contact

Adam Sturdivant, MPH

CONTACT

[email protected]

205-934-4042

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No history of diabetes or hypertension
  • Estimated Glomerular Filtration Rate > 60 ml/min/m^2
  • Structurally normal kidney on renal ultrasound
  • BMI < 27 kg/m^2

Exclusion criteria

  • Prisoners directly admitted from a correctional facility
  • Children < 19 years or under 50 kg body weight if age is unknown
  • Patients with end stage renal disease or preexisting glomerular filtration rate less than or equal to 30 mL/min/1.73 m^2 or need for dialysis
  • Patients with end stage heart disease on the cardiac transplant list
  • Patients undergoing procedures without vascular surgery
  • All transplant patients
  • Patients on ventricular assist devices
  • Patients undergoing emergency procedures
  • Patients with body mass index > 27kg/m^2
  • Any condition that would impede visualization of the kidneys by ultrasound

Treatment and study plan

Shear Wave Elastography

Diagnostic Test

Advanced ultrasound technique

Primary outcomes

  1. Diagnostic factor of Shear Wave Elastography

    Time frame: From the time of Informed Consent being given to 96 hours after consent being given

    Shear wave Elastography-derived Young's Elastic Modulus factor differentiating patients with Acute Kidney Injury post vascular surgery from healthy controls.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam B Sturdivant, MPH

CONTACT

[email protected]

205-934-4042

Ayesha Bryant, MD, MSPH

CONTACT

[email protected]

205-996-7383

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

The Biosonographic Index - A Novel Index for the Early Detection of Acute Kidney Injury After Vascular Surgery - an Exploratory Study.

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2019
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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