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.

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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

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

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.

Interested in participating?

Recruiting

Interested in participating?

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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.

Published trials that share one or more normalized conditions with this study.

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