Septic ShockPhase 3VESPERNCT06696391
Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock
A Phase 3 study testing Venous Excess Ultrasound (VEXUS)-Guided Management in people with Septic Shock and Sepsis, run by Western University, Canada at 1 site in Canada.
Trial summary
The goal of this pilot clinical trial is to determine if conducting a larger study using venous excess ultrasound (VEXUS) to guide fluid management in patients with septic shock is feasible. Septic shock is a life-threatening condition where infection causes dangerously low blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Sepsis, Shock
- What is being tested?
- Venous Excess Ultrasound (VEXUS)-Guided Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2024to 28 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Adult patients (≥18 years)
- Within 12 hours of meeting septic shock diagnosis based on following Sepsis-3 criteria: requirement for vasopressors to maintain organ perfusion, lactate > 2 mmol/L, and suspected or confirmed infection)
- Within 48 hours of intensive care unit admission.
Who cannot join
- Already receiving renal replacement therapy
- Patients for whom a decision to initiate renal replacement therapy has been made prior to study enrolment
- Patients who have limitations on medical therapy or restrictions on goals of care
- Active bleeding causing hemodynamic instability
- Veno-venous or veno-arterial extracorporeal membrane oxygenation
- Previously enrolment in study
Show all 16Show fewer
- 10% or more of body surface area acute burn injury
- Suspected or confirmed liver cirrhosis
- Established allergy to sulfa drugs;
- Patients receiving treatments that require continuous IV fluid infusions (e.g., diabetic ketoacidosis, diabetes insipidus)
- Unable to measure fluid balance accurately
- Contra-indication to study recommended interventions (e.g., diuretics, inotropes)
- Unable to perform VEXUS due to anatomical barriers (e.g., surgical dressings);
- Unable to complete VEXUS scan during the 6-hour resuscitation window
- Moderate to Severe Tricuspid Regurgitation
- Untreated Metabolic/biochemical findings (Hypokalemia [K+]< 3.0 mmol/L; metabolic alkalosis [Bicarbonate > 40 mmol/L and/or pH > 7.55], Hypomagnesemia [Mg2+] < 0.6, and Hypernatremia [Na+] > 155 mmol/L)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
London Health Sciences Center
London, Ontario, N6A5W9
John Basmaji, MD, 1-519-685-8500 ext. 55661, John.basmaji@lhsc.on.ca
About this study
Official title: Venous Excess Ultrasound (VEXUS)-Guided Management Versus Usual Care in Patients with Septic Shock: a Pilot Randomized Controlled Trial
The goal of this pilot clinical trial is to determine if conducting a larger study using venous excess ultrasound (VEXUS) to guide fluid management in patients with septic shock is feasible. Septic shock is a life-threatening condition where infection causes dangerously low blood pressure. While fluids are essential for treatment, too much fluid can harm the kidneys and result in the need for dialysis. The main questions it aims to answer are:
- Is it feasible to recruit patients, obtain consent, and follow the VEXUS-guided management protocol?
- Does VEXUS-guided management, compared with usual care, improve the health and well-being of patients with septic shock?
Read more
Researchers will compare two groups: one receiving VEXUS-guided fluid management versus another receiving standard care, to assess the feasibility of a larger trial and explore whether VEXUS prevents fluid overload and kidney problems.
Participants in the VEXUS group will:
- Undergo VEXUS scans every 24 hours for 3 days
- Receive fluid management guided by VEXUS findings (including fluid restriction or removal if we identify venous congestion) and undergo cardiac ultrasound if we identify moderate to severe congestion
- Be monitored for 28 days to track kidney function, need for dialysis, and survival.
- Conditions
- Septic Shock, Sepsis, Shock, Critical Care, Intensive Care, Resuscitation
- Being tested
- Venous Excess Ultrasound (VEXUS)-Guided Management
- Keywords
- Randomized Controlled Trial, Ultrasound, Venous Congestion, Septic Shock, Pilot Study, Resuscitation
- Medical subject headings
- Shock, Septic, Sepsis, Shock, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous Excess Ultrasound (VEXUS)-Guided ManagementOther
Expert operators will perform VEXUS within 6 hours of randomization and repeat the assessment every 24 hours for 3 days, or until ICU discharge or death. After each assessment, investigators will grade the severity of venous congestion using a modified version of the VEXUS score and provide updated management recommendations.
Patients without congestion will receive standard fluid management. For mild congestion, investigators will implement fluid restriction (e.g., minimizing maintenance fluids) while maintaining nutrition and blood product administration as clinically indicated. For moderate to severe congestion, investigators will 1. target negative fluid balance (-1 to -2L/24h) through fluid restriction and diuretics, 2. perform cardiac ultrasound to guide inotrope administration and optimize RV physiology, and 3. optimize PEEP for ventilated patients.
All patients will receive the standard of care based on Surviving Sepsis Campaign guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Venous Excess Ultrasound (VEXUS)-Guided Management | Experimental | Not described Receives: Other: Venous Excess Ultrasound (VEXUS)-Guided Management |
| Control Arm | No intervention | Investigators will provide patients with the standard of care according to the Surviving Sepsis Campaign guidelines. This includes fluid resuscitation, the recommended mean arterial pressure target of ≥65 mmHg, early broad-spectrum antibiotics, source control when applicable, vasopressor support with norepinephrine as the first-line agent, stress-dose corticosteroids, early nutrition, and lung-protective mechanical ventilation when required. Clinicians may utilize hemodynamics assessment tools such as dynamic measures of fluid responsiveness and point-of-care ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants enrolled during the recruitment period who successfully complete study procedures and follow-up.
Measured: Up to 160 weeks
Secondary outcomes (3)
Consent rate
The total number of eligible participants consented divided by the total number of eligible participants approached for consent.
Measured: From enrollment to the end of the study period at 28 days
VEXUS scan completion rate
The number of participants who successfully undergo a VEXUS scan and, if applicable, cardiac evaluation, divided by the total number of participants randomized to the intervention arm.
Measured: From enrollment to the end of treatment period at 3 days
Protocol Adherence
Intervention arm: For fluid balance adherence, we will calculate the proportion of participants who achieved the protocol-specified fluid balance targets on days 1 to 3, divided by the total number of participants in the intervention arm. This metric will account for participants who withdraw or deviate from the protocol. To assess adherence to inotrope initiation based on POCUS findings, we will determine the percentage of participants who received inotropes when indicated by POCUS results, as per protocol guidelines, divided by the total number of participants with POCUS findings warranting inotrope initiation.
Control arm: The number of participants in the control arm who do NOT receive a VEXUS scan during the 28-day study period (or until ICU discharge or death) divided by the total number randomized to this arm.
Measured: From enrollment to the end of treatment period at 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre
- Responsible party
- Principal investigator, John Basmaji, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696391
- Sponsor's protocol ID
- 125708
- Acronym
- VESPER
- Status last verified
- Oct 2024
- First submitted
- 14 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Excess Ultrasound (VEXUS)-Guided Management Versus Usual Care in Patients with Septic Shock: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06696391
- Acronym / sponsor ID
- VESPER / 125708
- Conditions
- Septic Shock, Sepsis, Shock, Critical Care, Intensive Care, Resuscitation
- Keywords
- Randomized Controlled Trial, Ultrasound, Venous Congestion, Septic Shock, Pilot Study, Resuscitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- London Health Sciences Centre
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 20 Nov 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.
The goal of this pilot clinical trial is to determine if conducting a larger study using venous excess ultrasound (VEXUS) to guide fluid management in patients with septic shock is feasible. Septic shock is a life-threatening condition where infection causes dangerously low blood pressure. While fluids are essential for treatment, too much fluid can harm the kidneys and result in the need for dialysis. The main questions it aims to answer are:
- Is it feasible to recruit patients, obtain consent, and follow the VEXUS-guided management protocol?
- Does VEXUS-guided management, compared with usual care, improve the health and well-being of patients with septic shock?
Researchers will compare two groups: one receiving VEXUS-guided fluid management versus another receiving standard care, to assess the feasibility of a larger trial and explore whether VEXUS prevents fluid overload and kidney problems.
Participants in the VEXUS group will:
- Undergo VEXUS scans every 24 hours for 3 days
- Receive fluid management guided by VEXUS findings (including fluid restriction or removal if we identify venous congestion) and undergo cardiac ultrasound if we identify moderate to severe congestion
- Be monitored for 28 days to track kidney function, need for dialysis, and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venous Excess Ultrasound (VEXUS)-Guided Management | Experimental | Other: Venous Excess Ultrasound (VEXUS)-Guided Management |
| Control Arm | No intervention | –Investigators will provide patients with the standard of care according to the Surviving Sepsis Campaign guidelines. This includes fluid resuscitation, the recommended mean arterial pressure target of ≥65 mmHg, early broad-spectrum antibiotics, source control when applicable, vasopressor support with norepinephrine as the first-line agent, stress-dose corticosteroids, early nutrition, and lung-protective mechanical ventilation when required. Clinicians may utilize hemodynamics assessment tools such as dynamic measures of fluid responsiveness and point-of-care ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥18 years)
- Within 12 hours of meeting septic shock diagnosis based on following Sepsis-3 criteria: requirement for vasopressors to maintain organ perfusion, lactate > 2 mmol/L, and suspected or confirmed infection)
- Within 48 hours of intensive care unit admission.
Key exclusion criteria (16 listed)
- Already receiving renal replacement therapy
- Patients for whom a decision to initiate renal replacement therapy has been made prior to study enrolment
- Patients who have limitations on medical therapy or restrictions on goals of care
- Active bleeding causing hemodynamic instability
- Veno-venous or veno-arterial extracorporeal membrane oxygenation
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 |
|---|---|---|
| Venous Excess Ultrasound (VEXUS)-Guided ManagementExpert operators will perform VEXUS within 6 hours of randomization and repeat the assessment every 24 hours for 3 days, or until ICU discharge or death. After each assessment, investigators will grade the severity of venous congestion using a modified version of the VEXUS score and provide updated management recommendations. Patients without congestion will receive standard fluid management. For mild congestion, investigators will implement fluid restriction (e.g., minimizing maintenance fluids) while maintaining nutrition and blood product administration as clinically indicated. For moderate to severe congestion, investigators will 1. target negative fluid balance (-1 to -2L/24h) through fluid restriction and diuretics, 2. perform cardiac ultrasound to guide inotrope administration and optimize RV physiology, and 3. optimize PEEP for ventilated patients. All patients will receive the standard of care based on Surviving Sepsis Campaign guidelines. | Other | Venous Excess Ultrasound (VEXUS)-Guided Management |
Primary outcome
Recruitment Rate
Time frame: Up to 160 weeks
Number of participants enrolled during the recruitment period who successfully complete study procedures and follow-up.
3 secondary outcomes
Consent rate
Time frame: From enrollment to the end of the study period at 28 days
VEXUS scan completion rate
Time frame: From enrollment to the end of treatment period at 3 days
Protocol Adherence
Time frame: From enrollment to the end of treatment period at 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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Sepsis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Venous Excess Ultrasound (VEXUS)-Guided Management in people with Septic Shock and Sepsis, run by Western University, Canada at 1 site in Canada.
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 3 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: opening soon, as of the sponsor's last update on 20 Nov 2024. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Basmaji, MD (1-519-685-8500 ext. 55661, john.basmaji@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Up to 160 weeks). 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 20 Nov 2024.