Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock

ConditionsSeptic Shock Sepsis Shock Critical Care, Intensive Care Resuscitation

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Venous Excess Ultrasound (VEXUS)-Guided Management
Other intervention
Expert operators will perform VEXUS within 6 hours of randomization and repeat the assessment every 24 hours for 3 days, or until ICU discharge or death. After each assessment, investigators will grade the severity of venous congestion using a modified version of the VEXUS score and provide updated management recommendations. Patients without congestion will receive standard fluid management. For mild congestion, investigators will implement fluid restriction (e.g., minimizing maintenance fluids) while maintaining nutrition and blood product administration as clinically indicated. For moderate to severe congestion, investigators will 1. target negative fluid balance (-1 to -2L/24h) through fluid restriction and diuretics, 2. perform cardiac ultrasound to guide inotrope administration and optimize RV physiology, and 3. optimize PEEP for ventilated patients. All patients will receive the standard of care based on Surviving Sepsis Campaign guidelines.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Venous Excess Ultrasound (VEXUS)-Guided ManagementExperimental treatment 1 intervention

Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

Recruitment Rate

Number of participants enrolled during the recruitment period who successfully complete study procedures and follow-up.

Time frame

Up to 160 weeks

Secondary outcomes

Consent rate

The total number of eligible participants consented divided by the total number of eligible participants approached for consent.

Time frame

From enrollment to the end of the study period at 28 days

VEXUS scan completion rate

The number of participants who successfully undergo a VEXUS scan and, if applicable, cardiac evaluation, divided by the total number of participants randomized to the intervention arm.

Time frame

From enrollment to the end of treatment period at 3 days

Protocol Adherence

Intervention arm: For fluid balance adherence, we will calculate the proportion of participants who achieved the protocol-specified fluid balance targets on days 1 to 3, divided by the total number of participants in the intervention arm. This metric will account for participants who withdraw or deviate from the protocol. To assess adherence to inotrope initiation based on POCUS findings, we will determine the percentage of participants who received inotropes when indicated by POCUS results, as per protocol guidelines, divided by the total number of participants with POCUS findings warranting inotrope initiation. Control arm: The number of participants in the control arm who do NOT receive a VEXUS scan during the 28-day study period (or until ICU discharge or death) divided by the total number randomized to this arm.

Time frame

From enrollment to the end of treatment period at 3 days

Other outcomes

Adverse events

Metabolic abnormalities: hypokalemia \< 3.0 mmol/L; hyponatremia \<130 mmol/L, or hypernatremia \> 155 mmol/L, metabolic alkalosis pH\>7.55 or bicarbonate \>40 mmol/L, and hypomagnesemia \< 0.6 mmol/L) Hemodynamic events: hypotension episodes (defined as mean arterial pressure \< 60 mmHg for 5 minutes or more), hypotension episodes requiring intervention (greater than 20% increase in vasopressor requirements from baseline or need for fluid bolus), tachyarrhythmias Organ Injury: acute kidney injury All adverse events will be reported daily for days 1 to 3

Time frame

From enrollment to the end of treatment period at 3 days

28-Day Mortality

Time frame

From enrollment to 28 days

90-Day Mortality

Time frame

From enrollment to 90 days

Duration of Vasoactive Medication

Defined as the time from initiation to the first successful discontinuation of vasopressors and inotropes, where successful discontinuation means no reinitiation for at least 12 consecutive hours

Time frame

From enrollment to the discontinuation of vasoactive medication, assessed up to 52 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Western University, Canada

Lead sponsor

London Health Sciences Centre

Collaborator

Source ClinicalTrials.gov

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