The Biosonographic Index

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04144894
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 41.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Diagnostic Test: Shear Wave Elastography	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Biosonographic Index - A Novel Index for the Early Detection of Acute Kidney Injury After Vascular Surgery - an Exploratory Study.
• Actual Study Start Date: Jan 15, 2020
• Anticipated Primary Completion Date: Sep 15, 2022
• Anticipated Study Completion Date: Jul 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy Controls	Diagnostic Test: Shear Wave Elastography; Advanced ultrasound technique
Other: Vascular Surgery Subjects	Diagnostic Test: Shear Wave Elastography; Advanced ultrasound technique

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35249

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Ahmed Zaky, MD, MPH, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Zaky, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT04144894
• Other Study ID Numbers: IRB-300003010
• First Posted: Oct 30, 2019
• Last Update Posted: Jan 28, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Acute Kidney Injury

Study Results

No Results Posted as of Jan 28, 2022