SepsisDRI-USNCT04921319
De-resuscitation Informed by Ultrasound for Patients With Sepsis
A study testing VExUS score in people with Sepsis and Septic Shock, run by The Miriam Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Sepsis, Severe
- What is being tested?
- VExUS score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2021to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Miriam Hospital
Providence, Rhode Island, 02906
Keith Corl, MD, keith_corl@brown.edu
About this study
Official title: Optimizing Fluid Management Informed by Ultrasound for Patients With Sepsis
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.
Read the 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.
- Conditions
- Sepsis, Septic Shock, Sepsis, Severe, Volume Overload
- Being tested
- VExUS score
- Medical subject headings
- Sepsis, Shock, Septic, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VExUS scoreDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| VExUS-Guided Arm | Experimental | Will receive 24 hour fluid balance target based on daily VExUS score. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Fluid Balance at 5 days post ICU discharge or ICU Discharge
Total fluid balance (ins minus outs)
Measured: At 5 days post ICU admission or ICU discharge, whichever comes first
Secondary outcomes (6)
Incidence of Acute Kidney Injury
acute kidney injury as defined by KDIGO criteria
Measured: At 5 days post ICU admission or ICU discharge, whichever comes first
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
Measured: At 5 days post ICU admission or ICU discharge, whichever comes first
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
Measured: At 5 days post ICU admission or ICU discharge, whichever comes first
28-day and in-hospital mortality
All-cause mortality.
Measured: 28 days and during hospital admission up to 24 weeks
ICU discharge fluid balance
Cumulative admission fluid balance at time of ICU discharge.
Measured: From ICU admission to ICU discharge or 30 days after ICU admission, whichever comes first
Daily Sonographic B Line Measurement
Measured by counting sonographic B lines in 16 lung zones
Measured: study enrollment to ICU discharge or 5 days post-enrollment, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start26 Apr 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, unblinded clinical trial of 152 critically ill patients with sepsis admitted to the intensive care unit.
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Corl, MD, Principal investigator, Rhode Island Hospital / The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921319
- Sponsor's protocol ID
- 1694487-1
- Acronym
- DRI-US
- Status last verified
- Mar 2021
- First submitted
- 7 Apr 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32270297
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Fluid Management Informed by Ultrasound for Patients With Sepsis
- ClinicalTrials.gov ID
- NCT04921319
- Acronym / sponsor ID
- DRI-US / 1694487-1
- Conditions
- Sepsis, Septic Shock, Sepsis, Severe, Volume Overload
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, unblinded clinical trial of 152 critically ill patients with sepsis admitted to the intensive care unit.
| Arm | Type | Receives |
|---|---|---|
| VExUS-Guided Arm | Experimental | Diagnostic Test: VExUS scoreWill receive 24 hour fluid balance target based on daily 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VExUS scoreThe 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. | Diagnostic test | VExUS-Guided Arm |
Primary outcome
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
Total fluid balance (ins minus outs)
6 secondary outcomes
Incidence of Acute Kidney Injury
Time frame: At 5 days post ICU admission or ICU discharge, whichever comes first
Incidence of respiratory failure
Time frame: At 5 days post ICU admission or ICU discharge, whichever comes first
Change in SOFA score
Time frame: At 5 days post ICU admission or ICU discharge, whichever comes first
28-day and in-hospital mortality
Time frame: 28 days and during hospital admission up to 24 weeks
ICU discharge fluid balance
Time frame: From ICU admission to ICU discharge or 30 days after ICU admission, whichever comes first
Daily Sonographic B Line Measurement
Time frame: study enrollment to ICU discharge or 5 days post-enrollment, whichever comes first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Background: PubMed 32270297Beaubien-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Corl, MD principal investigator
Rhode Island Hospital / The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VExUS score in people with Sepsis and Septic Shock, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher F Allison, MD (401-793-4501, callison@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04921319, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.