Not Yet RecruitingPhase 3

Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock

Canada80 participantsStarted 2024-12-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment Rate

Timeframe: Up to 160 weeks

Trial details

NCT IDNCT06696391

SponsorWestern University, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-28

Contact for this trial

John Basmaji, MD

1-519-685-8500 john.basmaji@lhsc.on.ca

View on ClinicalTrials.gov More Septic Shock trials