Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock

Launched by WESTERN UNIVERSITY, CANADA · Nov 18, 2024

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ClinConnect Summary

This clinical trial is studying a new way to manage fluids for patients with septic shock, a serious condition caused by infections that lead to dangerously low blood pressure. The researchers want to see if using a technique called venous excess ultrasound (VEXUS) can help doctors decide how much fluid a patient needs, which is crucial since too much fluid can harm the kidneys. The trial will compare two groups of patients: one group will have their fluid management guided by VEXUS, while the other group will receive standard care. The goal is to find out if this method is practical for a larger study and if it can help improve patients' health and prevent kidney problems.

To be eligible for this trial, participants must be adults aged 18 or older who have recently been diagnosed with septic shock and are in the intensive care unit. They will undergo VEXUS scans every day for three days, and their treatment will be adjusted based on the results of these scans. Participants will be monitored for 28 days to assess their kidney function, the need for dialysis, and their overall survival. It’s important to note that certain patients, such as those already on dialysis or with specific health conditions, may not be eligible for this trial.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Adult patients (≥18 years)
• • 2. 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)
• • 3. Within 48 hours of intensive care unit admission.
• Exclusion Criteria:
• • 1. Already receiving renal replacement therapy
• • 2. Patients for whom a decision to initiate renal replacement therapy has been made prior to study enrolment
• • 3. Patients who have limitations on medical therapy or restrictions on goals of care
• • 4. Active bleeding causing hemodynamic instability
• • 5. Veno-venous or veno-arterial extracorporeal membrane oxygenation
• • 6. Previously enrolment in study
• • 7. 10% or more of body surface area acute burn injury
• • 8. Suspected or confirmed liver cirrhosis
• • 9. Established allergy to sulfa drugs;
• • 10. Patients receiving treatments that require continuous IV fluid infusions (e.g., diabetic ketoacidosis, diabetes insipidus)
• • 11. Unable to measure fluid balance accurately
• • 12. Contra-indication to study recommended interventions (e.g., diuretics, inotropes)
• • 13. Unable to perform VEXUS due to anatomical barriers (e.g., surgical dressings);
• • 14. Unable to complete VEXUS scan during the 6-hour resuscitation window
• • 15. Moderate to Severe Tricuspid Regurgitation
• • 16. 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)