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NCT Number: NCT07406750

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.
  • ≥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

  • Patients with preexisting liver cirrhosis.
  • Pregnancy.

Treatment and study plan

Education in performing hemodynamic diagnostic ultrasound of venous congestion

Behavioral

Educational program in performing hemodynamic diagnostic ultrasound of venous congestion

Hemodynamic diagnostic ultrasound of venous congestion

Diagnostic Test

Hemodynamic diagnostic ultrasound of venous congestion

Other names: VeXUS

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Johanna Savilampi, MD

CONTACT

[email protected]

+46 019 6060266

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Collaborators

  • Dalarna County Council, Sweden
  • Region Östergötland
  • Örebro University, Sweden

Registry information

Official study title

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

Acronym: VEXIVAN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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