The Biosonographic Index

Not Applicable

Recruiting

• Conditions: Acute Kidney Injury
• Interventions: Diagnostic Test: Shear Wave Elastography

• Registration Number: NCT04144894
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Study Start: 2020-01-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2026-10-15
• Study Completion: 2026-12-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Controls	Shear Wave Elastography	-
Vascular Surgery Subjects	Shear Wave Elastography	-

Primary Outcome Measures

Name	Time	Method
Diagnostic factor of Shear Wave Elastography	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States