Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06586931

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

Primary outcomes

  1. VEXUS score

    Time frame: Baseline

    Assessment of fluid status in septic patients by VEXUS score

Secondary outcomes

  1. Accuracy of CVP for assessment of fluid status in septic patients

    Time frame: Baseline

    Comparison of CVP with VEXUS score to assess fluid status

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Emad thabet

CONTACT

[email protected]

01226360150

Mohamed Mostafa ali

CONTACT

[email protected]

01555429805

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.