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Not yet recruiting NCT06586931

Accuracy of Venous Excess Ultrasound (VEXUS) Score Versus Central Venous Pressure in Patients With Severe Sepsis

Observational Sepsis, Severe

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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sepsis, Severe. Basic parameters: 18 years — 75 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Accuracy of Venous Excess Ultrasound (VEXUS) Score Versus Central Venous Pressure to Assess Volume Status in Patients With Severe Sepsis

Overview

assessing septic patients with a noninvasive ultrasound protocol, and earlier identification of fluid overload to help clinicians decide whether to administer supplemental fluid therapy or suspend its administration and to evaluate the possible relation between the different VExUS grades and the adverse effects of intensive fluid administration

Detailed description

Sepsis is a life-threatening organ dysfunction caused by a poorly regulated host response to infection. Septic shock is still a leading cause of death worldwide as it can induce multi-organ failure (1).

Septic shock is a subset of sepsis with manifest circulatory dysfunction .intravenous fluid therapy is an essential intervention to promote hemodynamic stabilization.. Similarly, septic patients are a very different and difficult subset in intensive care unit (ICU). They are vasodilated and require fluid resuscitation for optimization of venous volume and cardiac output (2).

Central venous pressure measurement which has been used for ages, is not the ideal monitoring technique as it does not correlate with blood volume and does not give a true representation of the response of fluid challenge (3).

a venous excess Doppler ultrasound (VExUS) grading system, are parameters for the assessment of the fluid status of the patient and organ congestion. This protocol evaluates the amount of venous congestion in the abdominal organs, specifically by scanning the portal, hepatic, and intrarenal veins. Doppler interrogation of these vessels yields a specific pattern corresponding to a level of venous congestion: normal, mild, or severe. (4).

Primary outcome measures

  • VEXUS score [Time frame: Baseline]
Secondary outcome measures (1)
  • Accuracy of CVP for assessment of fluid status in septic patients [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • adult patients (≥ 18 years old) with the diagnosis of severe sepsis and clinical indication to be admitted in critical care units are recruited. Sepsis should be suspected to be the primary cause of their acute illness by the treating physician, consistent with the

Surviving Sepsis Campaign Guidelines (2021) :

  • Life-threatening organ dysfunction
  • Diagnosis of infection Some patients diagnosed with sepsis will not meet the criteria, but will be eligible for the study if the treating physician makes a clinical diagnosis of severe sepsis.

Exclusion criteria

  • 1\. Refusal to participate 2. Patients in hemodialysis program 3. Patients with previously known conditions that interfere with portal Doppler assessments, namely liver cirrhosis, or severe tricuspid regurgitation with structural heart disease. If any of these conditions are identified during the present episode, the patient would also be excluded.

4\. Age < 18 years 5. Patients subjected to withdrawal of care 6. Hemodynamic instability due to active hemorrhage 7. Acute coronary syndrome 8. Indication for immediate surgery 9. Received CPR within 24 hours of enrollment 10. Pregnancy

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Longino A, Martin K, Leyba K, Siegel G, Gill E, Douglas IS, Burke J. Correlation between the VExUS score and right atrial pressure: a pilot prospective observational study. Crit Care. 2023 May 26;27(1):205. doi: 10.1186/s13054-023-04471-0. PMID 37237315
  • Rola P, Miralles-Aguiar F, Argaiz E, Beaubien-Souligny W, Haycock K, Karimov T, Dinh VA, Spiegel R. Clinical applications of the venous excess ultrasound (VExUS) score: conceptual review and case series. Ultrasound J. 2021 Jun 19;13(1):32. doi: 10.1186/s13089-021-00232-8. PMID 34146184

Identifiers

NCT: NCT06586931 · VEXUS score in severe sepsis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗