Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock

Phase 3

Not yet recruiting

• Conditions: Septic Shock; Sepsis; Shock; Critical Care, Intensive Care; Resuscitation

• Registration Number: NCT06696391
• Lead Sponsor: Western University, Canada

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Study Start: 2024-12-01
• Primary Completion: 2027-12-28
• Study Completion: 2027-12-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment Rate	Up to 160 weeks	Number of participants enrolled during the recruitment period who successfully complete study procedures and follow-up.

Secondary Outcome Measures

Name	Time	Method
Consent rate	From enrollment to the end of the study period at 28 days	The total number of eligible participants consented divided by the total number of eligible participants approached for consent.
VEXUS scan completion rate	From enrollment to the end of treatment period at 3 days	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.
Protocol Adherence	From enrollment to the end of treatment period at 3 days	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.

Trial Locations

Locations (1)

London Health Sciences Center; 🇨🇦 London, Ontario, Canada