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The Biosonographic Index

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04144894
Enrollment
50
Registered
2019-10-30
Start date
2020-01-15
Completion date
2026-12-02
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

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.

Interventions

DIAGNOSTIC_TESTShear Wave Elastography

Advanced ultrasound technique

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic factor of Shear Wave ElastographyFrom the time of Informed Consent being given to 96 hours after consent being givenShear wave Elastography-derived Young's Elastic Modulus factor differentiating patients with Acute Kidney Injury post vascular surgery from healthy controls.

Countries

United States

Contacts

Primary ContactAdam B Sturdivant, MPH
Adamsturdivant@uabmc.edu205-934-4042
Backup ContactAyesha Bryant, MD, MSPH
Asbryant@uabmc.edu205-996-7383

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026