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NCT Number: NCT06696391

Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock

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.

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Key information

Conditions

Septic Shock Cardiovascular Diseases Critical Care, Intensive Care Hyperemia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Resuscitation Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

Venous Excess Ultrasound (VEXUS)-Guided Management

Other

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.

Primary outcomes

  1. Recruitment Rate

    Time frame: Up to 160 weeks

    Number of participants enrolled during the recruitment period who successfully complete study procedures and follow-up.

Secondary outcomes

  1. Consent rate

    Time frame: From enrollment to the end of the study period at 28 days

    The total number of eligible participants consented divided by the total number of eligible participants approached for consent.

  2. VEXUS scan completion rate

    Time frame: From enrollment to the end of treatment period at 3 days

    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.

  3. Protocol Adherence

    Time frame: From enrollment to the end of treatment period at 3 days

    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.

Other outcomes

  1. Adverse events

    Time frame: From enrollment to the end of treatment period at 3 days

    Metabolic abnormalities: hypokalemia < 3.0 mmol/L; hyponatremia <130 mmol/L, or hypernatremia > 155 mmol/L, metabolic alkalosis pH>7.55 or bicarbonate >40 mmol/L, and hypomagnesemia < 0.6 mmol/L) Hemodynamic events: hypotension episodes (defined as mean arterial pressure < 60 mmHg for 5 minutes or more), hypotension episodes requiring intervention (greater than 20% increase in vasopressor requirements from baseline or need for fluid bolus), tachyarrhythmias Organ Injury: acute kidney injury

    All adverse events will be reported daily for days 1 to 3

  2. 28-Day Mortality

    Time frame: From enrollment to 28 days

  3. 90-Day Mortality

    Time frame: From enrollment to 90 days

  4. Duration of Vasoactive Medication

    Time frame: From enrollment to the discontinuation of vasoactive medication, assessed up to 52 weeks

    Defined as the time from initiation to the first successful discontinuation of vasopressors and inotropes, where successful discontinuation means no reinitiation for at least 12 consecutive hours

  5. Days alive and free of vasoactive medications at 28 days

    Time frame: From enrollment to 28 days

  6. Duration of mechanical ventilation

    Time frame: From enrollment to the discontinuation of mechanical ventilation, assessed up to 52 weeks

    Defined as the time from initiation to the first successful liberation of mechanical ventilation, where successful liberation means no reinitiation of mechanical ventilation for at least 12 consecutive hours

  7. Days alive and free of mechanical ventilation at 28 days

    Time frame: From enrollment to 28 days

  8. Need for Renal Replacement Therapy

    Time frame: From enrollment to 28 days

    Proportion of patients who require renal replacement therapy at 28 days

  9. Days alive and free of renal replacement therapy at 28 days

    Time frame: From enrollment to 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

John Basmaji, MD

CONTACT

[email protected]

1-519-685-8500 ext. 55661

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Collaborators

  • London Health Sciences Centre

Registry information

Official study title

Venous Excess Ultrasound (VEXUS)-Guided Management Versus Usual Care in Patients with Septic Shock: a Pilot Randomized Controlled Trial

Acronym: VESPER

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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