The Biosonographic Index

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144894
• Other study ID #: IRB-300003010
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: December 2, 2024

Study information

• Verified date: October 2023
• Source: University of Alabama at Birmingham
• Contact: Adam B Sturdivant, MPH
• Phone: 205-934-4042
• Email: Adamsturdivant[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Diagnostic Test:
• Shear Wave Elastography
Advanced ultrasound technique

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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