Critically Ill PatientsVEXUSNCT06227702
Vexus-guided Fluid Management in Patients With Septic Shock After the Resuscitation Phase
A study testing Fluid management according to Venous Excess Ultrasound (VExUS) Score in people with Critically Ill Patients and Septic Shock, run by Federal University of São Paulo.
Trial summary
It is well recognized the association between fluid volume administered and positive fluid balance with adverse outcomes . Active fluid removal is widely practiced in an attempt to mitigate this potential damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients, Septic Shock
- What is being tested?
- Fluid management according to Venous Excess Ultrasound (VExUS) Score
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 28 Feb 2026
- 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
- Age over 18 years old.
- Hospitalization in ICU for at least 48 hours.
- Patient in septic shock for at least 24 hours and clinically stable defined by mean arterial pressure ≥ 65 mmHg and maximum infusion of 0.20 μg/kg/min of norepinephrine and lactate < 4.0 mmol/L.
- Signed informed consent
Who cannot join
- Patients in use of more than one vasopressor
- Known right ventricle dysfunction
- Indication to use furosemide for other reasons
- Hypernatremia (Na >160 mmol/L)
- Advanced acute kidney injury(KDIGO 3)
- Current renal replacement therapy
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- Anuria for ≥ 6 hours
- Hepatorenal syndrome
- Patients in palliative care
- Furosemide allergy.
- Rhabdomyolysis.
- Major burn
Trial locations and contacts
No sites are listed yet.
About this study
It is well recognized the association between fluid volume administered and positive fluid balance with adverse outcomes . Active fluid removal is widely practiced in an attempt to mitigate this potential damage. However, it is not clear which is the best approach for the post-resuscitation phase in critically ill patients. In this context, Point-of-Care ultrasound (POCUS) through Venous Excess Ultrasound (VExUS) would allow the assessment of the degree of venous congestion, through the visualization of vascular anatomy and blood velocity using Doppler, being potentially useful to guide fluid removal. The investigators will evaluate whether fluid management after the initial phase of VExUS-guided resuscitation is able to improve outcomes compared to usual therapy in patients with septic shock.
This is a single center, prospective, open and randomized clinical study in which patients admitted to intensive care will be included after the first 24 hours of resuscitation. A total of 200 patients will be randomized either to volume management guided by VExUS or to the standard therapy arm as per usual practice.
Read the detailed description
All patients hospitalized or admitted to the intensive care unit with septic shock will be screened for eligibility. Patients will be randomized using an electronic system (RedCap) to receive or not the intervention.
After 24 hours of shock onset, patients without hypoperfusion after informed consent will be allocated into two groups. In intervention arm wil be assessed by VeXus. Patients without signs of venous congestion (VeXus = 0) will continue to be observed every 6 hours. In patients with VeXus ≥1, continuous infusion of intravenous furosemide will be initiated. During the first 48 hours after inclusion in the study, patients will be evaluated for the intervention every 6 to 8 hours: Time 1 (T1) at randomization, T2 after 6 hours of T1, T3 after 6 hours of T2 and every 6 to 8 hours later. At these times, in patients with a reduction of at least one point in VeXus, the furosemide infusion will be maintained. If there is a worsening or no improvement of at least one point in the VeXus, the infusion will be doubled.In patients where there are signs of hypoperfusion, furosemide therapy will be discontinued. The administration of furosemide will also be interrupted in patients who develop serum sodium > 160 mEq/L; metabolic alkalosis (bicarbonate > 35 mEq/L) or potassium < 3mEq/L. In patients randomized to the usual therapy group, the attending physician will decide whether to prescribe furosemide or not according to his assessment without any defined time criteria. All other aspects of care will be managed according to routine unit protocols
- Conditions
- Critically Ill Patients, Septic Shock
- Being tested
- Fluid management according to Venous Excess Ultrasound (VExUS) Score
- Keywords
- vexus, fluid management, deresuscitation, deaccumulation
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid management according to Venous Excess Ultrasound (VExUS) ScoreOther
Management of furosemide intravenous infusion according to VeXus results
| Study group | Role | What they receive |
|---|---|---|
| VeXus | Active comparator | Patients in the intervention arm wil be assessed by VeXus. Patients without signs of venous congestion (VeXus = 0) will be observed every 6 hours. In patients with VeXus ≥1, continuous infusion of intravenous furosemide will be initiated. During the first 48 hours, furosemide infusion will be adjusted according to VeXus . All other aspects of care will be managed according to routine unit protocols Receives: Other: Fluid management according to Venous Excess Ultrasound (VExUS) Score |
| Usual care | No intervention | The usual care arm will follow the management protocols of the unit which are based in the Surviving Sepsis Campaign guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchy outcome: death in the ICU, need for renal replacement therapy during ICU stay and serum creatinine value on the third day after randomization
The outcome of the study will be assessed by the win rate ("Win ratio WR) between the intervention arm and the usual care arm defined by the occurrence in hierarchical order of one of the following events:
- Death in ICU
- Need for renal replacement therapy during ICU stay
- Serum creatinine value on the third day after randomization
Measured: three days
Secondary outcomes (2)
fluid balance
fluid balance during the first three days
Measured: three days
PaO2/FiO2
worst PaO2/FiO2 during the first three days
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill PatientsStudies 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 1:1
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Brazilian Research In Intensive Care Network
- Responsible party
- Principal investigator, Flavia Ribeiro Machado, Federal University of São Paulo
- Investigators
- Flavia Machado, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227702
- Sponsor's protocol ID
- VEXUS
- Acronym
- VEXUS
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized IPD will be provided upon request and after analysis of the study executive committee
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vexus-guided Fluid Management in Patients With Septic Shock After the Resuscitation Phase
- ClinicalTrials.gov ID
- NCT06227702
- Acronym / sponsor ID
- VEXUS / VEXUS
- Conditions
- Critically Ill Patients, Septic Shock
- Keywords
- vexus, fluid management, deresuscitation, deaccumulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Brazilian Research In Intensive Care Network
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 29 Jan 2024 (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.
It is well recognized the association between fluid volume administered and positive fluid balance with adverse outcomes . Active fluid removal is widely practiced in an attempt to mitigate this potential damage. However, it is not clear which is the best approach for the post-resuscitation phase in critically ill patients. In this context, Point-of-Care ultrasound (POCUS) through Venous Excess Ultrasound (VExUS) would allow the assessment of the degree of venous congestion, through the visualization of vascular anatomy and blood velocity using Doppler, being potentially useful to guide fluid removal. The investigators will evaluate whether fluid management after the initial phase of VExUS-guided resuscitation is able to improve outcomes compared to usual therapy in patients with septic shock.
This is a single center, prospective, open and randomized clinical study in which patients admitted to intensive care will be included after the first 24 hours of resuscitation. A total of 200 patients will be randomized either to volume management guided by VExUS or to the standard therapy arm as per usual practice.
Detailed description
All patients hospitalized or admitted to the intensive care unit with septic shock will be screened for eligibility. Patients will be randomized using an electronic system (RedCap) to receive or not the intervention.
After 24 hours of shock onset, patients without hypoperfusion after informed consent will be allocated into two groups. In intervention arm wil be assessed by VeXus. Patients without signs of venous congestion (VeXus = 0) will continue to be observed every 6 hours. In patients with VeXus ≥1, continuous infusion of intravenous furosemide will be initiated. During the first 48 hours after inclusion in the study, patients will be evaluated for the intervention every 6 to 8 hours: Time 1 (T1) at randomization, T2 after 6 hours of T1, T3 after 6 hours of T2 and every 6 to 8 hours later. At these times, in patients with a reduction of at least one point in VeXus, the furosemide infusion will be maintained. If there is a worsening or no improvement of at least one point in the VeXus, the infusion will be doubled.In patients where there are signs of hypoperfusion, furosemide therapy will be discontinued. The administration of furosemide will also be interrupted in patients who develop serum sodium > 160 mEq/L; metabolic alkalosis (bicarbonate > 35 mEq/L) or potassium < 3mEq/L. In patients randomized to the usual therapy group, the attending physician will decide whether to prescribe furosemide or not according to his assessment without any defined time criteria. All other aspects of care will be managed according to routine unit protocols
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| VeXus | Active comparator | Other: Fluid management according to Venous Excess Ultrasound (VExUS) ScorePatients in the intervention arm wil be assessed by VeXus. Patients without signs of venous congestion (VeXus = 0) will be observed every 6 hours. In patients with VeXus ≥1, continuous infusion of intravenous furosemide will be initiated. During the first 48 hours, furosemide infusion will be adjusted according to VeXus . All other aspects of care will be managed according to routine unit protocols |
| Usual care | No intervention | –The usual care arm will follow the management protocols of the unit which are based in the Surviving Sepsis Campaign guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years old.
- Hospitalization in ICU for at least 48 hours.
- Patient in septic shock for at least 24 hours and clinically stable defined by mean arterial pressure ≥ 65 mmHg and maximum infusion of 0.20 μg/kg/min of norepinephrine and lactate < 4.0 mmol/L.
- Signed informed consent
Key exclusion criteria (12 listed)
- Patients in use of more than one vasopressor
- Known right ventricle dysfunction
- Indication to use furosemide for other reasons
- Hypernatremia (Na >160 mmol/L)
- Advanced acute kidney injury(KDIGO 3)
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 |
|---|---|---|
| Fluid management according to Venous Excess Ultrasound (VExUS) ScoreManagement of furosemide intravenous infusion according to VeXus results | Other | VeXus |
Primary outcome
Hierarchy outcome: death in the ICU, need for renal replacement therapy during ICU stay and serum creatinine value on the third day after randomization
Time frame: three days
The outcome of the study will be assessed by the win rate ("Win ratio WR) between the intervention arm and the usual care arm defined by the occurrence in hierarchical order of one of the following events: * Death in ICU * Need for renal replacement therapy during ICU stay * Serum creatinine value on the third day after randomization
2 secondary outcomes
fluid balance
Time frame: three days
PaO2/FiO2
Time frame: three days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: Yes. Anonymized IPD will be provided upon request and after analysis of the study executive committee
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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.
Flavia Machado principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Fluid management according to Venous Excess Ultrasound (VExUS) Score in people with Critically Ill Patients and Septic Shock, run by Federal University of São Paulo.
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 4 inclusion and 12 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 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Flavia Machado (+55 11 996552410, frmachado@unifesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchy outcome: death in the ICU, need for renal replacement therapy during ICU stay and serum creatinine value on the third day after randomization (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2024.