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NCT06696391 | NOT YET RECRUITING | Septic Shock

Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock
Sponsor:

Western University, Canada

Information provided by (Responsible Party):

John Basmaji

Brief Summary:

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.

Condition or disease

Septic Shock

Sepsis

Shock

Critical Care, Intensive Care

Resuscitation

Intervention/treatment

Venous Excess Ultrasound (VEXUS)-Guided Management

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Venous Excess Ultrasound (VEXUS)-Guided Management Versus Usual Care in Patients with Septic Shock: a Pilot Randomized Controlled Trial
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2027-12-28
Estimated Study Completion Date : 2027-12-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock

Location Details

NCT06696391

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Canada, Ontario

London Health Sciences Center

London, Ontario, Canada, Natakhos