Acute Kidney InjuryNCT04144894
The Biosonographic Index
A study testing Shear Wave Elastography in people with Acute Kidney Injury, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Shear Wave Elastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 2 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Adam Sturdivant, MPH, 205-934-4042, Adamsturdivant@uabmc.edu
About this study
Official title: The Biosonographic Index - A Novel Index for the Early Detection of Acute Kidney Injury After Vascular Surgery - an Exploratory Study.
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.
- Conditions
- Acute Kidney Injury
- Being tested
- Shear Wave Elastography
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear Wave ElastographyDiagnostic test
Advanced ultrasound technique
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Other | Not described Receives: Diagnostic Test: Shear Wave Elastography |
| Vascular Surgery Subjects | Other | Not described Receives: Diagnostic Test: Shear Wave Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the time of Informed Consent being given to 96 hours after consent being given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start15 Jan 2020
- Primary completion15 Oct 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Zaky, University of Alabama at Birmingham
- Investigators
- Ahmed Zaky, MD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144894
- Sponsor's protocol ID
- IRB-300003010
- Other IDs
- UAB
- Status last verified
- Sep 2025
- First submitted
- 28 Oct 2019
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33201924
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biosonographic Index - A Novel Index for the Early Detection of Acute Kidney Injury After Vascular Surgery - an Exploratory Study.
- ClinicalTrials.gov ID
- NCT04144894
- Acronym / sponsor ID
- IRB-300003010
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Other | Diagnostic Test: Shear Wave Elastography |
| Vascular Surgery Subjects | Other | Diagnostic Test: Shear Wave Elastography |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shear Wave ElastographyAdvanced ultrasound technique | Diagnostic test | Healthy Controls, Vascular Surgery Subjects |
Primary outcome
Diagnostic factor of Shear Wave Elastography
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 33201924Zaky 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed Zaky, MD, MPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shear Wave Elastography in people with Acute Kidney Injury, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam B Sturdivant, MPH (205-934-4042, Adamsturdivant@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic factor of Shear Wave Elastography (time frame: From the time of Informed Consent being given to 96 hours after consent being given). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04144894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.