The Biosonographic Index

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Acute Kidney Injury

Treatments: Diagnostic Test: Shear Wave Elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT04144894

IRB-300003010

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Healthy Controls

Other group

Treatment:

Diagnostic Test: Shear Wave Elastography

Vascular Surgery Subjects

Other group

Treatment:

Diagnostic Test: Shear Wave Elastography