Randomized, unblinded clinical trial of 152 critically ill patients with sepsis admitted to the intensive care unit. The primary determine if using the Venous Excess Ultrasound Score (VExUS) to guide fluid deresuscitation in critically ill patients with sepsis reduces net fluid balance at 5 days as compared to usual care.
Physicians can assess venous congestions with point of care ultrasound of intraabdominal veins using the venous excess in ultrasound score (VExUS), which has been shown to predict the harmful effects of volume overload. We seek to determine if VExUS-guided deresuscitation reduces the fluid balance in critically ill patients with sepsis as compared to usual care. This score compiles findings from the inferior vena cava, hepatic vein Doppler waveform, portal vein Doppler waveform, and intrarenal vein Doppler waveform: Grade 0: IVC \< 2cm, normal pattern in flow patterns of hepatic, portal, and intrarenal veins Grade 1: IVC ≥ 2cm, normal patterns or mild abnormalities in flow patterns of hepatic, portal, and intrarenal veins. Grade 2: IVC ≥ 2cm, severe venous flow pattern in one among hepatic, portal, and intrarenal veins. Grade 3: IVC ≥ 2cm, severe venous flow pattern in multiple among hepatic, portal, and intrarenal veins. After informed consent, subjects will be randomized in a 1:1 ratio to the VExUS-guided intervention arm vs control arm. Subjects in both arms will undergo daily ultrasound, and the investigator will calculate the VExUS immediately after ultrasounds are obtained.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
The care team will be informed of the VExUS immediately after the ultrasound is performed and given a suggested target for the following 24 hours as follows: * VExUS 0: "The patient will likely tolerate more fluid if clinically needed." * VExUS 1: "The patient has evidence of mild venous congestion. The investigators recommend targeting a net neutral or negative fluid balance with diuresis." * VExUS 2-3: "The patient has evidence of moderate to severe venous congestion. The investigators recommend targeting a fluid balance of negative 1-2L with diuresis." If the investigator cannot obtain ultrasound images of sufficient quality to calculate VExUS, the care team will be informed that there is no recommendation for that subject on that day.
The Miriam Hospital
Providence, Rhode Island, United States
RECRUITINGCumulative Fluid Balance at 5 days post ICU discharge or ICU Discharge
Total fluid balance (ins minus outs)
Time frame: At 5 days post ICU admission or ICU discharge, whichever comes first
Incidence of Acute Kidney Injury
acute kidney injury as defined by KDIGO criteria
Time frame: At 5 days post ICU admission or ICU discharge, whichever comes first
Incidence of respiratory failure
Incidence of respiratory failure defined by intubation rates, ventilator free days, ventilator days, use of non-invasive positive pressure ventilation, and use of high flow oxygen
Time frame: At 5 days post ICU admission or ICU discharge, whichever comes first
Change in SOFA score
Change in Sequential Organ Failure Assessment (SOFA) score during study period, on scale of 0-48, with higher values being a worse outcome
Time frame: At 5 days post ICU admission or ICU discharge, whichever comes first
28-day and in-hospital mortality
All-cause mortality.
Time frame: 28 days and during hospital admission up to 24 weeks
ICU discharge fluid balance
Cumulative admission fluid balance at time of ICU discharge.
Time frame: From ICU admission to ICU discharge or 30 days after ICU admission, whichever comes first
Daily Sonographic B Line Measurement
Measured by counting sonographic B lines in 16 lung zones
Time frame: study enrollment to ICU discharge or 5 days post-enrollment, whichever comes first
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