Hemodynamic Venous Congestion Ultrasound (VExUS) by ICU Nurses in Sepsis Patients. (VEXIVAN)

February 13, 2026 updated by: Region Örebro County

Hemodynamic Diagnostic Ultrasound of Venous Congestion (VExUS) Performed by Intensive Care Nurses on Patients With Sepsis.

Sepsis is a serious condition where the body's immune response to infection overreacts, leading to organ damage and death. Venous congestion, a buildup of blood in the veins, can occur in sepsis and contribute to organ injury. VExUS (Venous Excess Ultrasound Score) is an ultrasound method that can detect congestion early. This study examines whether ICU nurses, after training, can perform VExUS reliably, explores their experiences, and investigates links between VExUS findings and clinical outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Sepsis is a serious and potentially life-threatening condition that happens when the body's defense system overreacts to an infection. This overreaction can reduce the oxygen supply to the body's organs, causing damage and, in severe cases, organ failure. Up to 30% of people with sepsis die from it, and it is one of the most common causes of death in intensive care units.

Venous congestion, which means blood builds up in the veins, can occur in sepsis-for example, due to fluid overload or reduced heart function. This condition has been linked to organ injury. The VExUS (Venous Excess Ultrasound Score) is an ultrasound-based method that evaluates blood flow in the body's main veins. It has shown promise for identifying patients with venous congestion early. By using VExUS, it may be possible to detect the risk of organ injury sooner in intensive care patients with sepsis.

Ultrasound is becoming an increasingly important diagnostic tool in intensive care and is now often used directly at the bedside. Doctors already use ultrasound in many clinical situations and have extensive experience with it. Intensive care nurses, however, have had less opportunity to use ultrasound. Increasing their skills in this area could improve patient care.

VExUS is a relatively simple method that assesses blood flow in central veins without requiring precise measurements, making it well suited as an introduction to ultrasound use.

The purpose of this study is to examine whether intensive care nurses, after training, can perform VExUS on sepsis patients reliably. In the long term, this study could lead to intensive care nurses routinely performing VExUS as part of their hemodynamic assessment of patients.The study also explores the nurses' experiences and confidence with the method, including interviews. In addition, it investigates whether venous congestion identified by VExUS is linked to clinical outcomes.

Study Type

Observational

Enrollment (Estimated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Intensive care nurses with a specialist degree in intensive care and intensive care patients with sepsis.

Description

Inclusion Criteria:

Intensive Care Nurses a) Intensive care nurse, specialist degree in intensive care. b) ≥1,5 years of experience in intensive care. c) ≥75% clinical employment rate at the ICU. d) Continued employment until 2026 at the ICU at Örebro University Hospital. e) Written informed consent Intensive Care Patients

  1. Patients with suspected or verified sepsis according to the Sepsis 3 criteria (suspected or confirmed infection), ≥qSOFA (systolic blood pressure < 90 mmHg, GCS ≤ 13, respiratory rate ≥ 22 per minute) or rise in SOFA score ≥ 2 points and admitted to the ICU.
  2. ≥18 years of age.

Exclusion Criteria:

Intensive Care Nurses

a) Personnel with primarily an administration position or less clinical duty at the ICU.

Intensive Care Patients

  1. Patients with preexisting liver cirrhosis.
  2. Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intensive care nurse
Intensive care nurses that perform hemodynamic diagnostic ultrasound acording to the VExUS protocol
Behavioral: Education in performing hemodynamic diagnostic ultrasound of venous congestion
Educational program in performing hemodynamic diagnostic ultrasound of venous congestion
Intensive care patients
Intensive care patients with sepsis
Diagnostic test: Hemodynamic diagnostic ultrasound of venous congestion
Hemodynamic diagnostic ultrasound of venous congestion
Other Names:
  • VeXUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensive care nurses' VExUS performance
Time Frame: two years
Intensive care nurses' performance, regarding ultrasound image quality and assessment of ultrasound images according to VExUS protocol, evaluated by two experts.
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-rater VExUS reliability
Time Frame: two years
Agreement of assessments of prior collected ultrasound images, according to VExUS protocol, performed by the same intensive care nurse.
two years
Inter-rater VExUS reliability
Time Frame: two years
Agreement of assessments of prior collected ultrasound images according to VExUS protocol performed by different intensive care nurses.
two years
Inter-rater VExUS image agreement
Time Frame: two years
Agreement of the ability to obtain ultrasound images according to VExUS protocol performed on the same intensive care patients by different intensive care nurses, in temporal proximity.
two years
Venous congestion measured by VExUS and fluid status
Time Frame: two years
Association of presence of venous congestion assessed by VExUS over time in septic intensive care patients and daily measures used to monitor fluid status, such as daily weight, daily fluid balance and cumulative fluid balance.
two years
Venous congestion measured by VExUS and clinical outcomes
Time Frame: two years
Association of presence of venous congestion assessed by VExUS over time in septic intensive care patients and clinical outcomes determined by mortality in the ICU, 30 days mortality, ICU length of stay, hospital length of stay, SOFA score, time in assisted ventilation, need of vasoactive agents, gastrointestinal dysfunction, acute kidney injury and physiological variables.
two years
Intensive care nurses' self-efficacy, confidence and experiences
Time Frame: two years
Differences in intensive care nurses' perceived self-efficacy and confidence at various time points during data collection, along with their experiences.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Örebro County

Collaborators

Region Östergötland
Örebro University, Sweden
Dalarna County Council, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEXIVAN01
  • CIV-25-05-052654 (Other Identifier: the Swedish Medicines Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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