Doppler Evaluation for Congestive Acute Kidney Injury in Critical Illness
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- University of Alabama at Birmingham
- Study ID
- NCT07291778
- Status
- Not Yet Recruiting
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Conditions
- Acute Kidney Injury
- VExUS
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fluid Management — OTHERFor 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 — OTHERPrimary team will not be informed about the patient's VExUS score and will not be given recommendations for fluid management
Study Details
This study will evaluate the use of the Venous Excess Ultrasound (VExUS) score to guide fluid management in critically ill ICU patients through a prospective, multi-aim design combining observational and randomized components. The study will be conducted in the medical intensive care unit (MICU), multidisciplinary critical care unit (MCCU), and cardiac care unit (CCU) at UAB.
Key Dates
- Start date
- Jul 1, 2026
- Status verified
- Apr 2026
- Primary completion
- Jul 1, 2027
- Completion
- Jul 1, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: InformedThe treating team receives the patient's VExUS results and management recommendations.
- Placebo Comparator: Non-informedThe treating team remains blinded to all VExUS findings and receives no feedback or recommendations.
Primary Outcome Measure
In-hospital Mortality [ Time Frame: up to 30 days ]
Central Contacts
- Timothy I Kennell, MD, PhD2059965864
- Steve Fox, MD2059965864
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham Medical Center | Birmingham | Alabama | 35294 | Steve Fox, MD (PRINCIPAL_INVESTIGATOR) Timothy I Kennell, MD, PhD (SUB_INVESTIGATOR) |
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