Back to resultsThe Biosonographic Index
Primary Purpose
Acute Kidney Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shear Wave Elastography
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Kidney Injury
Eligibility Criteria
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
Sites / Locations
- University of Alabama at BirminghamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Healthy Controls
Vascular Surgery Subjects
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04144894
First Posted
October 28, 2019
Last Updated
October 4, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04144894
Brief Title
The Biosonographic Index
Official Title
The Biosonographic Index - A Novel Index for the Early Detection of Acute Kidney Injury After Vascular Surgery - an Exploratory Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
October 15, 2024 (Anticipated)
Study Completion Date
December 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Controls
Arm Type
Other
Arm Title
Vascular Surgery Subjects
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Shear Wave Elastography
Intervention Description
Advanced ultrasound technique
Primary Outcome Measure Information:
Title
Diagnostic factor of Shear Wave Elastography
Description
Shear wave Elastography-derived Young's Elastic Modulus factor differentiating patients with Acute Kidney Injury post vascular surgery from healthy controls.
Time Frame
From the time of Informed Consent being given to 96 hours after consent being given
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam B Sturdivant, MPH
Phone
205-934-4042
Email
Adamsturdivant@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha Bryant, MD, MSPH
Phone
205-996-7383
Email
Asbryant@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Zaky, MD, MPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Sturdivant, MPH
Phone
205-934-4042
Email
Adamsturdivant@uabmc.edu
12. IPD Sharing Statement
Citations:
PubMed Identifier
33201924
Citation
Zaky A, Beck AW, Bae S, Sturdivant A, Liwo A, Zdenek N, McAnally N, Ahmad S, Meers B, Robbin M, Pittet JF, Tolwani A, Berkowitz D. The bio-sonographic index. A novel modality for early detection of acute kidney injury after complex vascular surgery. A protocol for an exploratory prospective study. PLoS One. 2020 Nov 17;15(11):e0241782. doi: 10.1371/journal.pone.0241782. eCollection 2020.
Results Reference
derived
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The Biosonographic Index
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