Ultrasound-Guided Management for Septic Shock
(VESPER Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Western University, Canada

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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 am 18 years old or older.

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

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Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Venous Excess Ultrasound (VEXUS)-Guided ManagementExperimental Treatment1 Intervention

Group II: Control ArmActive Control1 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.