NCT07124741

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

August 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 8, 2025

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 28 days following intensive care unit admission.

Secondary Outcomes (4)

  • Need for mechanical ventilation in relation to VEXUS score

    Within the first 72 hours of intensive care unit admission.

  • Duration of mechanical ventilation in relation to VEXUS score.

    From intensive care unit patients admission until extubation, up to 28 days.

  • Length of intensive care unit stay in relation to VEXUS score

    From intensive care unit admission until intensive care unit discharge, up to 28 days.

  • Vasopressor dose and duration in relation to VEXUS score.

    First 72 hours after intensive care unit admission

Study Arms (1)

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.

Diagnostic Test: Serial VEXUS Ultrasound Evaluation

Interventions

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.

Septic shock cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Nilgun Kavrut Ozturk, Professor

    University of Health Sciences Antalya Training and Research hospital

    STUDY CHAIR

Central Study Contacts

Nilgun Kavrut Ozturk, Professor

CONTACT

Havva Dikici, Medical Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2025

First Posted

August 15, 2025

Study Start

March 30, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

August 15, 2025

Record last verified: 2025-08