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| Name | Class |
|---|---|
| London Health Sciences Centre | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venous Excess Ultrasound (VEXUS)-Guided Management | Experimental |
| |
| Control Arm | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Number of participants enrolled during the recruitment period who successfully complete study procedures and follow-up. | Up to 160 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Consent rate | The total number of eligible participants consented divided by the total number of eligible participants approached for consent. | From enrollment to the end of the study period at 28 days |
| VEXUS scan completion rate |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Basmaji, MD | Contact | 1-519-685-8500 | 55661 | john.basmaji@lhsc.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Center | London | Ontario | N6A5W9 | Canada |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| D012769 | Shock |
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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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.
| 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. | From enrollment to the end of treatment period at 3 days |
| From enrollment to the end of treatment period at 3 days |
| 28-Day Mortality | From enrollment to 28 days |
| 90-Day Mortality | 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 | From enrollment to the discontinuation of vasoactive medication, assessed up to 52 weeks |
| Days alive and free of vasoactive medications at 28 days | 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 | From enrollment to the discontinuation of mechanical ventilation, assessed up to 52 weeks |
| Days alive and free of mechanical ventilation at 28 days | From enrollment to 28 days |
| Need for Renal Replacement Therapy | Proportion of patients who require renal replacement therapy at 28 days | From enrollment to 28 days |
| Days alive and free of renal replacement therapy at 28 days | From enrollment to 28 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |