Ultrasound-Guided Management for Septic Shock

(VESPER Trial)

Overseen By John Basmaji, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Western University, Canada

Must not be taking: Sulfa drugs, Continuous IV fluids

Disqualifiers: Renal therapy, Liver cirrhosis, ECMO, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for managing fluids in patients with septic shock, a serious condition where an infection causes dangerously low blood pressure. Researchers aim to determine if using a special ultrasound, Venous Excess Ultrasound (VEXUS), to guide fluid treatment can prevent kidney problems more effectively than standard care. Participants will be divided into two groups: one will receive fluid management based on the ultrasound, while the other will receive usual care. The trial seeks individuals recently diagnosed with septic shock who are in intensive care. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving treatments that require continuous IV fluid infusions, you may not be eligible to participate.

What prior data suggests that the VEXUS-guided management protocol is safe for patients with septic shock?

Recent studies have used Venous Excess Ultrasound (VEXUS) to manage fluids in patients with septic shock. The findings suggest that VEXUS can help doctors identify excess fluid in the body, which is crucial because too much fluid can harm the kidneys.

Research shows that VEXUS scans can detect blood backing up in the veins, aiding doctors in deciding when to limit or remove fluids. This approach aims to prevent kidney problems and reduce the need for dialysis. Although these studies focus on evaluating VEXUS's effectiveness, there is no clear data yet on specific side effects from VEXUS-guided management.

Since this trial is in a later phase, it indicates that earlier studies have shown some level of safety. Additionally, VEXUS has been explored in other studies related to septic shock, reflecting ongoing interest and investigation by the medical community, which can be a positive sign regarding its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Venous Excess Ultrasound (VEXUS)-Guided Management for septic shock because it offers a new approach to monitoring and managing fluid levels in the body. Unlike the standard of care, which relies on general guidelines for fluid resuscitation and hemodynamic assessments, VEXUS uses ultrasound to provide a more precise, real-time evaluation of venous congestion. This method has the potential to tailor fluid management more accurately, reducing the risk of fluid overload and improving patient outcomes. By leveraging ultrasound technology, VEXUS could significantly enhance decision-making in critical care settings.

What evidence suggests that VEXUS-guided management is effective for septic shock?

Research has shown that using Venous Excess Ultrasound (VEXUS) to guide fluid management in septic shock may help reduce kidney problems. In this trial, participants in the VEXUS-Guided Management arm will receive treatment focused on reducing excess fluid in the veins, potentially lowering the need for dialysis. Studies have found that excess fluid in the veins is linked to worse outcomes, such as sudden kidney issues. Early evidence suggests that VEXUS-guided care could improve survival rates by better managing fluid levels. This method is being explored to enhance patient outcomes in septic shock. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with septic shock, a serious condition where an infection leads to dangerously low blood pressure. Participants must be in intensive care and able to follow the study's fluid management protocol. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I was admitted to the ICU less than 48 hours ago.

I was diagnosed with septic shock recently, needing drugs for blood pressure and have high lactate levels.

Exclusion Criteria

I couldn't complete a VEXUS scan within 6 hours of resuscitation.

Unable to measure fluid balance accurately

I have burns covering 10% or more of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VEXUS-guided fluid management or standard care for septic shock

3 days

Daily VEXUS scans for 3 days

Follow-up

Participants are monitored for kidney function, need for dialysis, and survival

28 days

What Are the Treatments Tested in This Trial?

Interventions

• Venous Excess Ultrasound (VEXUS)-Guided Management

Trial Overview The trial tests if using venous excess ultrasound (VEXUS) for fluid management improves outcomes in septic shock patients compared to standard care. It involves VEXUS scans over three days, tailored fluid treatment based on scan results, and monitoring kidney function and survival for 28 days.

How Is the Trial Designed?

Group I: Venous Excess Ultrasound (VEXUS)-Guided Management Experimental Treatment 1 Intervention

Group II: Control Arm Active Control 1 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 Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12386882/

The VTI-VeXUS Index in Septic Shock - PubMed Central - NIH To ensure accuracy, outcome data were reviewed in duplicate by a study investigator, blinded to the patient's venous congestion status and ...

2. annalsofintensivecare.springeropen.com annalsofintensivecare.springeropen.com/articles/10.1186/s13613-025-01529-w

Association between the Venous Excess Ultrasound (VExUS ... The primary outcome was the prevalence of acute kidney injury (AKI) during ICU stay, while secondary outcomes included 30-day mortality, ICU ...

3. link.springer.com link.springer.com/article/10.1007/s44349-025-00029-x

Venous excess ultrasound score-guided fluid resuscitation ... This study aims to compare the effect of fluid resuscitation based on the surviving sepsis campaign recommendations (SSC) versus fluid ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06696391

Study Details | NCT06696391 | Venous Excess Ultrasound ... Does VEXUS-guided management, compared with usual care, improve the health and well-being of patients with septic shock? Researchers will compare two groups: ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/13/7/e074843

Doppler identified venous congestion in septic shock Venous congestion is associated with worse outcomes, particularly acute kidney injury (AKI), for critically ill patients. Venous congestion can be measured by ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10155730/

Evaluation Of Congestion Levels in Septic Patients Admitted ... Our main hypothesis is that adding a modified lung ultrasound score to the VExUS protocol could provide higher sensitivity and earlier identification of fluid ...

7. mdpi.com mdpi.com/2077-0383/14/16/5774

The VTI-VeXUS Index in Septic Shock: An Exploratory ... Possible VeXUS scores range from 0 to 3. Scores of 0 or 1 represented 'no venous congestion' and scores of 2 or 3 represented moderate to severe 'venous ...

8. annemergmed.com annemergmed.com/article/S0196-0644(21)01057-X/fulltext

204 A Higher Initial VExUS Score Is Associated With ... Our data shows that in septic ED patients, higher VExUS scores were significantly associated with higher odds of mortality, ICU admission, or rapid response ...