Study Results
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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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2026-01-07
2027-06-01
Brief Summary
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Detailed Description
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Informed Arm: The treating team receives the patient's VExUS results and management recommendations.
Not-Informed Arm: The treating team remains blinded to all VExUS findings and receives no feedback or recommendations.
Each enrolled patient will undergo two VExUS ultrasound assessments:
Timepoint 1 (enrollment): Two scans are performed by separate operators to assess waveform reliability and inter-user reproducibility.
Timepoint 2 (48-72 hours after enrollment): A single scan is performed along with concurrent collection of serum creatinine, intake/output (I\&O) balance, and renal replacement therapy (RRT) status.
Each VExUS exam includes Doppler evaluation of the inferior vena cava, hepatic vein, portal vein, renal cortical artery, and renal cortical vein. Scans are saved to secure UAB SharePoint storage labeled with an auto-incrementing study ID.
Blinding Procedures
To maintain study integrity and minimize bias, multiple layers of blinding will be employed:
Scanner Blinding: Sonographers performing the VExUS scans are blinded to the patient's randomization status and to all prior scan results. They collect and upload de-identified images labeled only by study ID.
Interpreter Blinding: The attending physician interpreting the scans (the "overreader") is blinded to randomization status during the image interpretation phase. The overreader reviews both scans for quality and assigns a VExUS score (0-3) before randomization status is revealed.
Recruiter/Coordinator Role: The research coordinator (unblinded) maintains the randomization list and is responsible for communicating the overread results to the treating team only for patients in the informed arm.
Primary Team Blinding: For patients in the not-informed arm, the primary clinical team will not receive any VExUS scores or recommendations, and no study-related documentation will be visible in the electronic health record (EHR).
Statistical Blinding: Data analysts will remain blinded to treatment arm allocation until after all primary outcomes are recorded.
Communication and Clinical Guidance
For patients in the informed arm, the overreader will generate standardized recommendations based on the VExUS score:
VExUS = 0: Recommend a net positive fluid balance.
VExUS = 1: Recommend a net neutral fluid balance.
VExUS \>= 2: Recommend a net negative fluid balance.
These recommendations will be communicated to the treating team via a structured process: documentation in the EHR under the POCUS note and verbal handoff to the resident, fellow, and attending on the primary team.
Data Management and Analysis
Two linked data lists will be maintained:
Master List (PHI-protected): Contains patient identifiers and MRNs, stored on a secure UAB server.
Patient Data List (de-identified): Contains study ID, randomization arm, scan quality, interpreter scores, creatinine values, I\&O data, RRT status, ICU-free days, hospital-free days, and mortality.
All ultrasound procedures are noninvasive and adhere to ACEP emergency ultrasound standards. Protected health information will remain secured on institutional servers, and only de-identified data will be used for analysis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Scanner Blinding: Sonographers performing the VExUS scans are blinded to the patient's randomization status and to all prior scan results. They collect and upload de-identified images labeled only by study ID.
Interpreter Blinding: The attending physician interpreting the scans (the "overreader") is blinded to randomization status during the image interpretation phase. The overreader reviews both scans for quality and assigns a VExUS score (0-3) before randomization status is revealed.
Recruiter/Coordinator Role: The research coordinator (unblinded) maintains the randomization list and is responsible for communicating the overread results to the treating team only for patients in the informed arm.
Primary Team Blinding: For patients in the not-informed arm, the primary clinical team will not receive any VExUS scores or recommendations, and no study-related documentation will be visible in
Study Groups
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Informed
The treating team receives the patient's VExUS results and management recommendations.
Fluid Management
For patients in the informed arm, the overreader will generate standardized recommendations based on the VExUS score:
VExUS = 0: Recommend a net positive fluid balance.
VExUS = 1: Recommend a net neutral fluid balance.
VExUS \>= 2: Recommend a net negative fluid balance.
These recommendations will be communicated to the treating team via a structured process: documentation in the EHR under the POCUS note and verbal handoff to the resident, fellow, and attending on the primary team.
Non-informed
The treating team remains blinded to all VExUS findings and receives no feedback or recommendations.
No intervention
Primary team will not be informed about the patient's VExUS score and will not be given recommendations for fluid management
Interventions
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Fluid Management
For patients in the informed arm, the overreader will generate standardized recommendations based on the VExUS score:
VExUS = 0: Recommend a net positive fluid balance.
VExUS = 1: Recommend a net neutral fluid balance.
VExUS \>= 2: Recommend a net negative fluid balance.
These recommendations will be communicated to the treating team via a structured process: documentation in the EHR under the POCUS note and verbal handoff to the resident, fellow, and attending on the primary team.
No intervention
Primary team will not be informed about the patient's VExUS score and will not be given recommendations for fluid management
Eligibility Criteria
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Inclusion Criteria
* Admitted to the MICU, MCCU, or CCU within 24 hours of admission
* Acute kidney injury (AKI) (based on Kidney Disease: Improving Global Outcomes (KDIGO) criteria)
* Adequate acoustic windows for a complete VExUS scan
Exclusion Criteria
* pregnant women
* End-stage renal disease (ESRD) or prior renal transplant
* Acute tubular necrosis (ATN) defined by urinalysis (≥2+ protein, ≥2+ blood, ≥1 muddy brown cast, ≥1 RBC cast, or ≥1 dysmorphic RBC)'
* Prior Whipple procedures
* currently incarcerated
18 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Steven W Fox
Assistant Professor
Locations
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University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Timothy I Kennell, MD, PhD
Role: primary
Other Identifiers
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UAB
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-300015346
Identifier Type: -
Identifier Source: org_study_id