Septic ShockNCT07124741
Prognostic Power of the VEXUS Score in Septic Shock: Effectiveness in Mortality Prediction
An observational study of Septic Shock and VExUS, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, VExUS
- What is being tested?
- Serial VEXUS Ultrasound Evaluation
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2026to 20 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the intensive care unit with a diagnosis of septic shock according to Sepsis-3 criteria. Patients will be enrolled consecutively from the intensive care unit of a tertiary care university hospital. Informed consent will be obtained from all patients or their legal representatives.
Who may be able to join
- Age>18
- Patients monitored for septic shock in intensive care unit
- Signed informed consent
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Havva Dikici, Medical Doctor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Antalya Training and Research Hospital
Antalya
About this study
Official title: Prognostic Power of the VEXUS Score in Septic Shock: Efficacy in Mortality Prediction
This study aims to evaluate the prognostic power of the VEXUS Score in predicting mortality among patients with septic shock in intensive care units.
Read the 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
- Being tested
- Serial VEXUS Ultrasound Evaluation
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial VEXUS Ultrasound EvaluationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Serial VEXUS Ultrasound Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day intensive care unit mortality in relation to VEXUS score
Investigation of the relationship between VEXUS Score and 28-day mortality in patients diagnosed with septic shock in the intensive care unit.
Measured: Up to 28 days following intensive care unit admission.
Secondary outcomes (4)
Need for mechanical ventilation in relation to VEXUS score
Evaluation of the association between initial VEXUS score and the requirement for mechanical ventilation in patients
Measured: Within the first 72 hours of intensive care unit admission.
Duration of mechanical ventilation in relation to VEXUS score.
Assessment of the correlation between VEXUS scores and the total duration of mechanical ventilation in intensive care unit patients with septic shock.
Measured: From intensive care unit patients admission until extubation, up to 28 days.
Length of intensive care unit stay in relation to VEXUS score
Investigation of the association between VEXUS score pregression and total length of intensive care unit stay in patients with septic shock.
Measured: From intensive care unit admission until intensive care unit discharge, up to 28 days.
Vasopressor dose and duration in relation to VEXUS score.
Assessment of the relationship between serial VEXUS scores and the cumulative dose and duration of vasopressor therapy during the first 72 hours in patients diagnosed with septic shock.
Measured: First 72 hours after intensive care unit admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start30 Mar 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nilgun Kavrut Ozturk, Antalya Training and Research Hospital
- Investigators
- Nilgun Kavrut Ozturk, Professor, Study chair, University of Health Sciences Antalya Training and Research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124741
- Sponsor's protocol ID
- 2024-435
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Power of the VEXUS Score in Septic Shock: Efficacy in Mortality Prediction
- ClinicalTrials.gov ID
- NCT07124741
- Acronym / sponsor ID
- 2024-435
- Conditions
- Septic Shock, VExUS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic shock cohort | – | Diagnostic Test: Serial VEXUS Ultrasound EvaluationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the intensive care unit with a diagnosis of septic shock according to Sepsis-3 criteria. Patients will be enrolled consecutively from the intensive care unit of a tertiary care university hospital. Informed consent will be obtained from all patients or their legal representatives.
Key inclusion criteria (3 listed)
- Age>18
- Patients monitored for septic shock in intensive care unit
- Signed informed consent
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial VEXUS Ultrasound EvaluationUltrasound 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. | Diagnostic test | Septic shock cohort |
Primary outcome
28-day intensive care unit mortality in relation to VEXUS score
Time frame: Up to 28 days following intensive care unit admission.
Investigation of the relationship between VEXUS Score and 28-day mortality in patients diagnosed with septic shock in the intensive care unit.
4 secondary outcomes
Need for mechanical ventilation in relation to VEXUS score
Time frame: Within the first 72 hours of intensive care unit admission.
Duration of mechanical ventilation in relation to VEXUS score.
Time frame: From intensive care unit patients admission until extubation, up to 28 days.
Length of intensive care unit stay in relation to VEXUS score
Time frame: From intensive care unit admission until intensive care unit discharge, up to 28 days.
Vasopressor dose and duration in relation to VEXUS score.
Time frame: First 72 hours after intensive care unit admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Havva Dikici, Medical Doctor contact
Nilgun Kavrut Ozturk, Professor study chair
University of Health Sciences Antalya Training and Research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and VExUS, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nilgun Kavrut Ozturk, Professor (+905334196049, kavrut@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day intensive care unit mortality in relation to VEXUS score (time frame: Up to 28 days following intensive care unit admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.