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Doppler Evaluation for Congestive Acute Kidney Injury in Critical Illness

ConditionsAcute Kidney InjuryVExUS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥18 years old)

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

Disqualifiers

< 18 years old

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)'

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fluid Management

    Other intervention

    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

    Other intervention

    Primary team will not be informed about the patient's VExUS score and will not be given recommendations for fluid management

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: InformedExperimental treatment 1 intervention
Group B: Non-informedPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

In-hospital Mortality

In-hospital mortality: Death from any cause before hospital discharge, within the 30-day window.

Time frame
up to 30 days
2

Renal Replacement Therapy

New receipt of Renal Replacement Therapy (RRT): Receiving dialysis or another form of RRT for the first time.

Time frame
up to 30 days
3

Persistent Renal Dysfunction

Persistent renal dysfunction: The final serum creatinine value before hospital discharge (within 30 days) is 200% (twice) or more of the patient's baseline creatinine value.

Time frame
up to 30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: