The Biosonographic Index

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Diagnostic test: Shear Wave Elastography

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam B Sturdivant, MPH; Phone Number: 205-934-4042; Email: Adamsturdivant@uabmc.edu
• Study Contact Backup: Name: Ayesha Bryant, MD, MSPH; Phone Number: 205-996-7383; Email: Asbryant@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Adam Sturdivant, MPH; Phone Number: 205-934-4042; Email: Adamsturdivant@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy Controls	Diagnostic test: Shear Wave Elastography; Advanced ultrasound technique
Other: Vascular Surgery Subjects	Diagnostic test: Shear Wave Elastography; Advanced ultrasound technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic factor of Shear Wave Elastography	Shear wave Elastography-derived Young's Elastic Modulus factor differentiating patients with Acute Kidney Injury post vascular surgery from healthy controls.	From the time of Informed Consent being given to 96 hours after consent being given

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Ahmed Zaky, MD, MPH, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Zaky A, Beck AW, Bae S, Sturdivant A, Liwo A, Zdenek N, McAnally N, Ahmad S, Meers B, Robbin M, Pittet JF, Tolwani A, Berkowitz D. The bio-sonographic index. A novel modality for early detection of acute kidney injury after complex vascular surgery. A protocol for an exploratory prospective study. PLoS One. 2020 Nov 17;15(11):e0241782. doi: 10.1371/journal.pone.0241782. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 2, 2026

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: IRB-300003010; UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No