A Phase 3 interventional study of Venous Excess Ultrasound (VEXUS)-Guided Management in Septic Shock, Sepsis and Shock, sponsored by Western University, Canada. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Western University, Canada · Phase 3, Interventional, and Treatment
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:
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:
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Western University, Canada is the lead sponsor of 221 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Venous Excess Ultrasound (VEXUS)-Guided Management
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.
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.
Recruitment Rate
Number of participants enrolled during the recruitment period who successfully complete study procedures and follow-up.
Time frame: Up to 160 weeks
Consent rate
The total number of eligible participants consented divided by the total number of eligible participants approached for consent.
Time frame: From enrollment to the end of the study period at 28 days
VEXUS scan completion rate
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.
Time frame: From enrollment to the end of treatment period at 3 days
Protocol Adherence
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.
Time frame: From enrollment to the end of treatment period at 3 days
Adverse events
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
Time frame: From enrollment to the end of treatment period at 3 days
28-Day Mortality
Time frame: From enrollment to 28 days
90-Day Mortality
Time frame: From enrollment to 90 days
Duration of Vasoactive Medication
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
Time frame: From enrollment to the discontinuation of vasoactive medication, assessed up to 52 weeks
Days alive and free of vasoactive medications at 28 days
Time frame: From enrollment to 28 days
Duration of mechanical ventilation
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
Time frame: From enrollment to the discontinuation of mechanical ventilation, assessed up to 52 weeks
Days alive and free of mechanical ventilation at 28 days
Time frame: From enrollment to 28 days
Need for Renal Replacement Therapy
Proportion of patients who require renal replacement therapy at 28 days
Time frame: From enrollment to 28 days
Days alive and free of renal replacement therapy at 28 days
Time frame: From enrollment to 28 days
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Western University, Canada