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

80 Participants Needed

Trial Summary

What is the purpose of this 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: 1. Is it feasible to recruit patients, obtain consent, and follow the VEXUS-guided management protocol? 2. 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: 1. Undergo VEXUS scans every 24 hours for 3 days 2. 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 3. Be monitored for 28 days to track kidney function, need for dialysis, and survival.

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 data supports the effectiveness of the treatment Venous Excess Ultrasound (VEXUS)-Guided Management for septic shock?

The Venous Excess Ultrasound (VExUS) technique has been shown to be useful in managing fluid balance by assessing venous congestion, which is important in conditions like acute kidney injury and heart failure. This suggests it could help guide treatment in septic shock by preventing fluid overload and ensuring proper blood flow. ^{1 2 3 4 5}

Is ultrasound-guided management for septic shock safe for humans?

The studies on Venous Excess Ultrasound (VExUS) focus on its use to measure venous congestion and guide treatment in various conditions, but they do not specifically address safety concerns. However, the use of ultrasound itself is generally considered safe as it is a non-invasive imaging technique. ^{1 2 3 4 5}

How is the VEXUS-guided treatment for septic shock different from other treatments?

The VEXUS-guided treatment for septic shock is unique because it uses ultrasound to measure venous congestion, helping doctors manage fluid balance more precisely. This approach is different from traditional methods that may not use such detailed imaging to guide treatment decisions. ^{1 2 3 4 5}

Eligibility Criteria

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.

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

Unable to measure fluid balance accurately

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Prospective Evaluation of Venous Excess Ultrasound (VExUS) for Estimation of Venous Congestion. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Perioperative Venous Excess Ultrasound Score (VExUS) to Guide Decongestion in a Dilated Cardiomyopathy Patient Presenting for Urgent Surgery. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Prevalence of systemic venous congestion assessed by Venous Excess Ultrasound Grading System (VExUS) and association with acute kidney injury in a general ICU cohort: a prospective multicentric study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Utility of bedside ultrasound derived hepatic and renal parenchymal flow patterns to guide management of acute kidney injury. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Feasibility and Utility of the Venous Excess Ultrasound Score to Detect and Grade Central Venous Pressure Elevation in Critically Ill Children. [2022]