The Biosonographic Index

NCT ID: NCT04144894

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2026-12-02

Brief Summary

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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

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Controls

Group Type OTHER

Shear Wave Elastography

Intervention Type DIAGNOSTIC_TEST

Advanced ultrasound technique

Vascular Surgery Subjects

Group Type OTHER

Shear Wave Elastography

Intervention Type DIAGNOSTIC_TEST

Advanced ultrasound technique

Interventions

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Shear Wave Elastography

Advanced ultrasound technique

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Zaky

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Zaky, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adam B Sturdivant, MPH

Role: CONTACT

205-934-4042

Ayesha Bryant, MD, MSPH

Role: CONTACT

205-996-7383

Facility Contacts

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Adam Sturdivant, MPH

Role: primary

205-934-4042

References

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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.

Reference Type DERIVED
PMID: 33201924 (View on PubMed)

Other Identifiers

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UAB

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300003010

Identifier Type: -

Identifier Source: org_study_id

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