Clinical trial NCT06696391: Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock
Official title: Venous Excess Ultrasound (VEXUS)-Guided Management Versus Usual Care in Patients with Septic Shock: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Septic Shock
Sepsis
Shock
Critical Care, Intensive Care
Resuscitation
Keywords: Randomized Controlled Trial
Ultrasound
Venous Congestion
Septic Shock
Pilot Study
Resuscitation
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
First posted: 2024-11-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Recruitment Rate
timeFrame: Up to 160 weeks
Secondary outcomes:
measure: Consent rate
timeFrame: From enrollment to the end of the study period at 28 days
measure: VEXUS scan completion rate
timeFrame: From enrollment to the end of treatment period at 3 days
measure: Protocol Adherence
timeFrame: From enrollment to the end of treatment period at 3 days
Other outcomes:
measure: Adverse events
timeFrame: From enrollment to the end of treatment period at 3 days
measure: 28-Day Mortality
timeFrame: From enrollment to 28 days
measure: 90-Day Mortality
timeFrame: From enrollment to 90 days
measure: Duration of Vasoactive Medication
timeFrame: From enrollment to the discontinuation of vasoactive medication, assessed up to 52 weeks
measure: Days alive and free of vasoactive medications at 28 days
timeFrame: From enrollment to 28 days
measure: Duration of mechanical ventilation
timeFrame: From enrollment to the discontinuation of mechanical ventilation, assessed up to 52 weeks
measure: Days alive and free of mechanical ventilation at 28 days
timeFrame: From enrollment to 28 days
measure: Need for Renal Replacement Therapy
timeFrame: From enrollment to 28 days
measure: Days alive and free of renal replacement therapy at 28 days
timeFrame: From enrollment to 28 days
Locations:
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
Study officials:
References: