De-resuscitation Informed by Ultrasound for Patients With Sepsis

NCT04921319 | Unknown

• 1 other identifier: 1694487-1
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of Acute Kidney Injury

  At 5 days post ICU admission or ICU discharge, whichever comes first

• Incidence of respiratory failure

  At 5 days post ICU admission or ICU discharge, whichever comes first

• Change in SOFA score

  At 5 days post ICU admission or ICU discharge, whichever comes first

• 28-day and in-hospital mortality

  28 days and during hospital admission up to 24 weeks

• ICU discharge fluid balance

  From ICU admission to ICU discharge or 30 days after ICU admission, whichever comes first

Study Arms (2)

VExUS-Guided Arm

EXPERIMENTAL

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

Diagnostic Test: VExUS score

Usual Care Control Arm

NO INTERVENTION

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 DIAGNOSTIC_TEST

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.

VExUS-Guided Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• Temperature of \> 38 C or \< 36 C
• Heart rate of \> 90/min
• Respiratory rate of \> 20/min or PaCO2 \< 32 mm Hg
• 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.

You may not qualify if:

• Patients with conditions that may interfere with portal Doppler assessments such as cirrhosis or portal thrombosis
• 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).
• Age \< 18 years
• Active atrial fibrillation or atrial flutter
• Hemodynamic instability due to active hemorrhage
• Acute cerebral vascular event
• Acute coronary syndrome (excluding elevated troponin thought to be from demand ischemia)
• Acute pulmonary edema
• Status asthmaticus
• Drug overdose
• Injury from burn or trauma
• Status epilepticus
• Indication for immediate surgery
• Received CPR within 24 hours of enrollment
• Pregnancy

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

Related 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.

  PMID: 32270297 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic; Edema

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Signs and Symptoms

Study Officials

• Keith Corl, MD

  Rhode Island Hospital / The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher F Allison, MD

CONTACT

401-793-4501; callison@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, unblinded clinical trial of 152 critically ill patients with sepsis admitted to the intensive care unit.

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: June 10, 2021
• Study Start: April 26, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: June 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)