The Biosonographic Index
2 other identifiers
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
1 active site
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
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedStudy Start
First participant enrolled
January 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 2, 2026
September 19, 2025
September 1, 2025
6.8 years
October 28, 2019
September 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Healthy Controls
OTHERVascular Surgery Subjects
OTHERInterventions
Advanced ultrasound technique
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Related Publications (1)
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.
PMID: 33201924DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Zaky, MD, MPH
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 28, 2019
First Posted
October 30, 2019
Study Start
January 15, 2020
Primary Completion (Estimated)
October 15, 2026
Study Completion (Estimated)
December 2, 2026
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share