De-resuscitation Informed by Ultrasound for Patients With Sepsis (DRI-US)

Lifespan

Status: Unknown

Conditions: Sepsis, Severe; Volume Overload; Septic Shock; Sepsis

Treatments: Diagnostic Test: VExUS score

Study type: Interventional

Funder types: Other

Identifiers

NCT04921319

1694487-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  2. Temperature of > 38 C or < 36 C

  3. Heart rate of > 90/min

  4. Respiratory rate of > 20/min or PaCO2 < 32 mm Hg

  5. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

VExUS-Guided Arm

Experimental group

Description:

Will receive 24 hour fluid balance target based on daily VExUS score.

Treatment:

Diagnostic Test: VExUS score

Usual Care Control Arm

No Intervention group

Description:

Treating team will be blinded to results of daily VExUS score and will set 24 hour fluid balance target based on usual care.