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

Primary Purpose

Sepsis, Septic Shock, Sepsis, Severe

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

VExUS score

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:
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:

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
Incarceration.

Sites / Locations

The Miriam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VExUS-Guided Arm

Usual Care Control Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cumulative Fluid Balance at 5 days post ICU discharge or ICU Discharge

Total fluid balance (ins minus outs)

Secondary Outcome Measures

Incidence of Acute Kidney Injury

acute kidney injury as defined by KDIGO criteria

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

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

28-day and in-hospital mortality

All-cause mortality.

ICU discharge fluid balance

Cumulative admission fluid balance at time of ICU discharge.

Daily Sonographic B Line Measurement

Measured by counting sonographic B lines in 16 lung zones

Full Information

NCT ID

NCT04921319

First Posted

April 7, 2021

Last Updated

June 2, 2021

Sponsor

The Miriam Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04921319

Brief Title

De-resuscitation Informed by Ultrasound for Patients With Sepsis

Acronym

DRI-US

Official Title

Optimizing Fluid Management Informed by Ultrasound for Patients With Sepsis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 26, 2021 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis, Septic Shock, Sepsis, Severe, Volume Overload

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VExUS-Guided Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Usual Care Control Arm

Arm Type

No Intervention

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

VExUS score

Intervention Description

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 Information:

Title

Cumulative Fluid Balance at 5 days post ICU discharge or ICU Discharge

Description

Total fluid balance (ins minus outs)

Time Frame

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

Secondary Outcome Measure Information:

Title

Incidence of Acute Kidney Injury

Description

acute kidney injury as defined by KDIGO criteria

Time Frame

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

Title

Incidence of respiratory failure

Description

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

Time Frame

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

Title

Change in SOFA score

Description

Change in Sequential Organ Failure Assessment (SOFA) score during study period, on scale of 0-48, with higher values being a worse outcome

Time Frame

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

Title

28-day and in-hospital mortality

Description

All-cause mortality.

Time Frame

28 days and during hospital admission up to 24 weeks

Title

ICU discharge fluid balance

Description

Cumulative admission fluid balance at time of ICU discharge.

Time Frame

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

Title

Daily Sonographic B Line Measurement

Description

Measured by counting sonographic B lines in 16 lung zones

Time Frame

study enrollment to ICU discharge or 5 days post-enrollment, whichever comes first

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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. Exclusion Criteria: 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 Incarceration.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christopher F Allison, MD

Phone

401-793-4501

callison@lifespan.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Keith Corl, MD

Organizational Affiliation

Rhode Island Hospital / The Miriam Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Miriam Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Keith Corl, MD

keith_corl@brown.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32270297

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.

Results Reference

background

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De-resuscitation Informed by Ultrasound for Patients With Sepsis

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