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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04921319
Other study ID # 1694487-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 26, 2021
Est. completion date July 30, 2022

Study information

Verified date March 2021
Source The Miriam Hospital
Contact Christopher F Allison, MD
Phone 401-793-4501
Email callison@lifespan.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 152
Est. completion date July 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 1. Must be suspected by the treating physician to have sepsis as the primary cause of their acute illness as exhibited by 2 or more of the following Systemic Inflammatory Response Syndrome (SIRS) criteria: 1. Temperature of > 38 C or < 36 C 2. Heart rate of > 90/min 3. Respiratory rate of > 20/min or PaCO2 < 32 mm Hg 4. White blood cell count > 12000/mm3 or < 4000/mm3 or >10% immature bands. 2. Known or suspected infection at the time of screening 3. Admission to the ICU for <24 hours Since approximately 12% of patients ultimately diagnosed with sepsis do not meet SIRS criteria, SIRS negative patients will be eligible for the study if the treating physician makes a clinical diagnosis of severe sepsis or septic shock. Exclusion Criteria: 1. Patients with conditions that may interfere with portal Doppler assessments such as cirrhosis or portal thrombosis 2. Patients with severe chronic kidney disease (estimated glomerular filtration rate<15 mL/min per 1.73 m2 calculated using the Modified Diet in Renal Disease formula). 3. Age < 18 years 4. Active atrial fibrillation or atrial flutter 5. Hemodynamic instability due to active hemorrhage 6. Acute cerebral vascular event 7. Acute coronary syndrome (excluding elevated troponin thought to be from demand ischemia) 8. Acute pulmonary edema 9. Status asthmaticus 10. Drug overdose 11. Injury from burn or trauma 12. Status epilepticus 13. Indication for immediate surgery 14. Received CPR within 24 hours of enrollment 15. Pregnancy 16. Incarceration.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
VExUS score
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.

Locations

Country Name City State
United States The Miriam Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative Fluid Balance at 5 days post ICU discharge or ICU Discharge Total fluid balance (ins minus outs) At 5 days post ICU admission or ICU discharge, whichever comes first
Secondary Incidence of Acute Kidney Injury acute kidney injury as defined by KDIGO criteria At 5 days post ICU admission or ICU discharge, whichever comes first
Secondary 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 At 5 days post ICU admission or ICU discharge, whichever comes first
Secondary 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 At 5 days post ICU admission or ICU discharge, whichever comes first
Secondary 28-day and in-hospital mortality All-cause mortality. 28 days and during hospital admission up to 24 weeks
Secondary ICU discharge fluid balance Cumulative admission fluid balance at time of ICU discharge. From ICU admission to ICU discharge or 30 days after ICU admission, whichever comes first
Secondary Daily Sonographic B Line Measurement Measured by counting sonographic B lines in 16 lung zones study enrollment to ICU discharge or 5 days post-enrollment, whichever comes first
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