Recruiting NCT04144894
The Biosonographic Index
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shear Wave Elastography.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Biosonographic Index - A Novel Index for the Early Detection of Acute Kidney Injury After Vascular Surgery - an Exploratory Study.
Overview
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.
Interventions
- Diagnostic test Shear Wave Elastography
Advanced ultrasound technique
Primary outcome measures
- Diagnostic factor of Shear Wave Elastography [Time frame: From the time of Informed Consent being given to 96 hours after consent being given]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
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. PMID 33201924
Identifiers
NCT: NCT04144894 · IRB-300003010 · UAB