Prognostic Power of the VEXUS Score in Septic Shock: Effectiveness in Mortality Prediction

NCT ID: NCT07124741

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-03-30
• Study Completion Date: 2026-08-31

Brief Summary

This study aims to evaluate the prognostic power of the VEXUS Score in predicting mortality among patients with septic shock in intensive care units.

Detailed Description

After the diagnosis of septic shock, patients will be assessed for eligibility. Following informed consent, measurements will be taken within the first 4 hours of shock onset, and treatment (inotropic and vasopressor doses, fluid challenge, corticosteroids) will be recorded. A second measurement will occur between 12 and 24 hours, and a third at 72 hours. All treatment and care protocols will be managed according to routine unit protocols.

Data will be systematically collected at three time points (0-4 hours, 12-24 hours, and 72 hours). These will include hemodynamic parameters, laboratory tests (including infection markers), need for renal replacement therapy, mechanical ventilation requirement and duration, cumulative dose and duration of vasopressor use, ICU stay, and survival status.

VEXUS Score Grading

The VEXUS score will be graded as follows:

• Grade 0 (No Congestion): No signs of venous congestion are detected. The inferior vena cava (IVC) diameter is less than 2 cm.
• Grade 1 (Mild Venous Congestion): The IVC diameter is 2 cm or greater. However, hepatic, portal, or renal vein flow measurements exhibit normal waveform patterns, or only one mildly abnormal waveform pattern is present.
• Grade 2 (Moderate Venous Congestion): The IVC diameter is 2 cm or greater. Additionally, analysis of hepatic, portal, or renal vein waveforms reveals one severe congestion finding.
• Grade 3 (Severe Venous Congestion): The IVC diameter is 2 cm or greater. Furthermore, analysis of hepatic, portal, or renal vein waveforms shows two or more severe congestion findings.

Data will be analyzed using SPSS version 23.0, with normality assessed through visual and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). Continuous variables will be compared using t-tests or Mann-Whitney U tests, and categorical variables using Chi-square tests. ROC analysis will be used to assess the predictive value of VEXUS for mortality.

Conditions

Septic Shock; VExUS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Septic shock cohort

All patients diagnosed with septic shock in the ıntensive care unit will undergo serial ultrasonographic evaluations to calculate the VEXUS Score at 0-4 hours, 12-24 hours, and 72 hours. These scores will be analyzed in relation to 28-day mortality. No treatment decisions will be made based on the VEXUS results.

Serial VEXUS Ultrasound Evaluation

Intervention Type: DIAGNOSTIC_TEST

Ultrasound assessments will be performed by an experienced anesthesiologist at three time points (0-4 hours, 12-24 hours, and 72 hours)to determine the degree of venous congestion using the VEXUS Score. No treatment changes will be made based on the VEXUS findings. The scores will solely be used for prognostic correlation with mortality outcomes.

Interventions

Serial VEXUS Ultrasound Evaluation

Ultrasound assessments will be performed by an experienced anesthesiologist at three time points (0-4 hours, 12-24 hours, and 72 hours)to determine the degree of venous congestion using the VEXUS Score. No treatment changes will be made based on the VEXUS findings. The scores will solely be used for prognostic correlation with mortality outcomes.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age>18
• Patients monitored for septic shock in intensive care unit
• Signed informed consent

Exclusion Criteria

• Age <18
• Severe obesity precluding adequate ultrasonographic imaging.
• Patients in whom venous structures cannot be clearly assessed via ultrasonography due to anatomical or technical reasons (e.g., adhesions following abdominal surgery).
• Patients receiving dialysis due to chronic kidney disease or initiating dialysis for acute kidney failure.
• Chronic heart failure.
• Patients with advanced valvular insufficiency or advanced pulmonary hypertension.
• Patients with portal hypertension or advanced-stage liver cirrhosis.
• Presence of acute or chronic thrombosis in the inferior vena cava or other venous structures within the scoring area.
• Refusal to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Nilgun Kavrut Ozturk

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nilgun Kavrut Ozturk, Professor

Role: STUDY_CHAIR

University of Health Sciences Antalya Training and Research hospital

Central Contacts

Nilgun Kavrut Ozturk, Professor

Role: CONTACT

kavrut@yahoo.com

+905334196049

Havva Dikici, Medical Doctor

Role: CONTACT

Other Identifiers

2024-435

Identifier Type: -

Identifier Source: org_study_id