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Behavioural Intervention

Ultrasound-Guided Management for Septic Shock (VESPER Trial)

Phase 3

Waitlist Available

Research Sponsored by Western University, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Adult patients (≥18 years)

Must not have

10% or more of body surface area acute burn injury

Suspected or confirmed liver cirrhosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 160 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to see if using venous excess ultrasound (VEXUS) to guide fluid management in patients with septic shock is possible. Septic shock is a severe condition where an infection leads

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly mentioned but may include discomfort from frequent ultrasound scans or risks associated with possible fluid restriction or removal due to VEXUS findings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have or might have liver cirrhosis.

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I cannot take certain medications recommended for this study.

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

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I have moderate to severe leakage in my heart valve.

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I am currently on dialysis.

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I am scheduled to start dialysis.

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I am on continuous IV fluids for conditions like diabetic ketoacidosis.

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I am currently experiencing severe bleeding that affects my blood pressure.

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I cannot undergo VEXUS due to physical barriers like surgical dressings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 160 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 160 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 160 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recruitment Rate

Secondary study objectives

Consent rate

Protocol Adherence

VEXUS scan completion rate

Other study objectives

Adverse events

Duration of Vasoactive Medication

Duration of mechanical ventilation

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 13Eligibility criteria met