Clinical trial NCT06586931: Accuracy of Venous Excess Ultrasound (VEXUS) Score Versus Central Venous Pressure in Patients With Severe Sepsis
Official title: Accuracy of Venous Excess Ultrasound (VEXUS) Score Versus Central Venous Pressure to Assess Volume Status in Patients With Severe Sepsis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis, Severe
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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,

Brief summary: 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).

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

Primary outcomes:
measure: VEXUS score
timeFrame: Baseline
Secondary outcomes:
measure: Accuracy of CVP for assessment of fluid status in septic patients
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Minia U
name: Jozef Zekry, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.