Recruiting

Ultrasound

Sponsor:

The Miriam Hospital

Code:

NCT04921319

Conditions

Sepsis

Septic Shock

Sepsis, Severe

Volume Overload

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VExUS score

Study Details

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.

Conditions

Sepsis

Septic Shock

Sepsis, Severe

Volume Overload

Study ID

NCT04921319

Start date

Apr 26, 2021

Status verified date

Mar, 2021

Completion date

Jul 30, 2022

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VExUS-Guided Arm

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

no intervention: Usual Care Control Arm

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

Interventions

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.

Primary outcome measure

  • Cumulative Fluid Balance at 5 days post ICU discharge or ICU Discharge [ Time Frame: At 5 days post ICU admission or ICU discharge, whichever comes first ]

Central Contacts and Locations

Central contacts

Christopher F Allison, MD

401-793-4501callison@lifespan.org

Locations

The Miriam Hospital

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

Keith Corl, MD

keith_corl@brown.edu

More Information

Sponsor

The Miriam Hospital

Last update posted

Jun 10, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2021-06-10.