Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock

NCT06696391 | Not Yet Recruiting Phase 3

• 1 other identifier: 125708
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.Is it feasible to recruit patients, obtain consent, and follow the VEXUS-guided management protocol?
2. 2.Does VEXUS-guided management, compared with usual care, improve the health and well-being of patients with septic shock?
3. 3.Undergo VEXUS scans every 24 hours for 3 days
4. 4.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
5. 5.Be monitored for 28 days to track kidney function, need for dialysis, and survival.

Conditions

Septic Shock; Sepsis; Shock; Critical Care, Intensive Care; Resuscitation

Keywords

Randomized Controlled Trial; Ultrasound; Venous Congestion; Septic Shock; Pilot Study; Resuscitation

Outcome Measures

Primary Outcomes (1)

• Recruitment Rate

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

  Up to 160 weeks

Secondary Outcomes (3)

• Consent rate

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

• VEXUS scan completion rate

  From enrollment to the end of treatment period at 3 days

• Protocol Adherence

  From enrollment to the end of treatment period at 3 days

Other Outcomes (9)

• Adverse events

  From enrollment to the end of treatment period at 3 days

• 28-Day Mortality

  From enrollment to 28 days

• 90-Day Mortality

  From enrollment to 90 days

Study Arms (2)

Venous Excess Ultrasound (VEXUS)-Guided Management

EXPERIMENTAL

Other: Venous Excess Ultrasound (VEXUS)-Guided Management

Control Arm

NO INTERVENTION

Investigators will provide patients with the standard of care according to the Surviving Sepsis Campaign guidelines. This includes fluid resuscitation, the recommended mean arterial pressure target of ≥65 mmHg, early broad-spectrum antibiotics, source control when applicable, vasopressor support with norepinephrine as the first-line agent, stress-dose corticosteroids, early nutrition, and lung-protective mechanical ventilation when required. Clinicians may utilize hemodynamics assessment tools such as dynamic measures of fluid responsiveness and point-of-care ultrasound.

Interventions

Venous Excess Ultrasound (VEXUS)-Guided Management OTHER

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.

Venous Excess Ultrasound (VEXUS)-Guided Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Veno-venous or veno-arterial extracorporeal membrane oxygenation
• Previously enrolment in study
• % or more of body surface area acute burn injury
• Suspected or confirmed liver cirrhosis
• Established allergy to sulfa drugs;
• Patients receiving treatments that require continuous IV fluid infusions (e.g., diabetic ketoacidosis, diabetes insipidus)
• Unable to measure fluid balance accurately
• Contra-indication to study recommended interventions (e.g., diuretics, inotropes)
• Unable to perform VEXUS due to anatomical barriers (e.g., surgical dressings);
• Unable to complete VEXUS scan during the 6-hour resuscitation window
• Moderate to Severe Tricuspid Regurgitation

Sponsors & Collaborators

• Western University, Canada: lead
• London Health Sciences Centre: collaborator

Study Sites (1)

London Health Sciences Center

London, Ontario, N6A5W9, Canada

Location

MeSH Terms

Conditions

Shock, Septic; Sepsis; Shock; Hyperemia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

John Basmaji, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Critical Care Physician

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 20, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): December 28, 2027
• Last Updated: November 20, 2024

Record last verified: 2024-10

Locations

CA (1)