Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern University, Canada
About this trial
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
Qualifiers
Adult patients (≥18 years)
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)
Within 48 hours of intensive care unit admission.
Disqualifiers
Already receiving renal replacement therapy
Patients for whom a decision to initiate renal replacement therapy has been made prior to study enrolment
Patients who have limitations on medical therapy or restrictions on goals of care
Active bleeding causing hemodynamic instability
Trial design
Treatments tested in this trial
- Venous Excess Ultrasound (VEXUS)-Guided Management
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Western University, Canada
Lead sponsor
London Health Sciences Centre
Collaborator
Source ClinicalTrials.gov