Clinical trial NCT04921319: De-resuscitation Informed by Ultrasound for Patients With Sepsis
Official title: Optimizing Fluid Management Informed by Ultrasound for Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Septic Shock
Sepsis, Severe
Volume Overload
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, unblinded clinical trial of 152 critically ill patients with sepsis admitted to the intensive care unit.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative Fluid Balance at 5 days post ICU discharge or ICU Discharge
timeFrame: At 5 days post ICU admission or ICU discharge, whichever comes first
Secondary outcomes:
measure: Incidence of Acute Kidney Injury
timeFrame: At 5 days post ICU admission or ICU discharge, whichever comes first
measure: Incidence of respiratory failure
timeFrame: At 5 days post ICU admission or ICU discharge, whichever comes first
measure: Change in SOFA score
timeFrame: At 5 days post ICU admission or ICU discharge, whichever comes first
measure: 28-day and in-hospital mortality
timeFrame: 28 days and during hospital admission up to 24 weeks
measure: ICU discharge fluid balance
timeFrame: From ICU admission to ICU discharge or 30 days after ICU admission, whichever comes first
measure: Daily Sonographic B Line Measurement
timeFrame: study enrollment to ICU discharge or 5 days post-enrollment, whichever comes first
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital / The Miriam Hospital
name: Keith Corl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.