Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock

NCT ID: NCT06696391

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-12-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venous Excess Ultrasound (VEXUS)-Guided Management

Group Type: EXPERIMENTAL

Venous Excess Ultrasound (VEXUS)-Guided Management

Intervention Type: 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.

Control Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Venous Excess Ultrasound (VEXUS)-Guided Management

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre

OTHER

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

John Basmaji

Critical Care Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

London Health Sciences Center

London, Ontario, Canada

Countries

Canada

Central Contacts

John Basmaji, MD

Role: CONTACT

john.basmaji@lhsc.on.ca

1-519-685-8500 ext. 55661

Facility Contacts

John Basmaji, MD

Role: primary

John.basmaji@lhsc.on.ca

1-519-685-8500 ext. 55661

Other Identifiers

125708

Identifier Type: -

Identifier Source: org_study_id