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Not yet recruiting NCT06696391

Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock

Phase III Interventional Septic Shock Sepsis Shock Critical Care, Intensive Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Venous Excess Ultrasound (VEXUS)-Guided Management.
Who it may be relevant to
Registry conditions: Septic Shock, Sepsis, Shock, Critical Care, Intensive Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Venous Excess Ultrasound (VEXUS)-Guided Management Versus Usual Care in Patients with Septic Shock: a Pilot Randomized Controlled Trial

Overview

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.

Interventions

  • Other 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 fluid

Primary outcome measures

  • Recruitment Rate [Time frame: Up to 160 weeks]
Secondary outcome measures (3)
  • Consent rate [Time frame: From enrollment to the end of the study period at 28 days]
  • VEXUS scan completion rate [Time frame: From enrollment to the end of treatment period at 3 days]
  • Protocol Adherence [Time frame: From enrollment to the end of treatment period at 3 days]

Eligibility criteria

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
  • Active bleeding causing hemodynamic instability
  • Veno-venous or veno-arterial extracorporeal membrane oxygenation
  • Previously enrolment in study
  • 10% 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
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • London Health Sciences Center — London

Identifiers

NCT: NCT06696391 · 125708

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗