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Not yet recruitingNCT07406750VEXIVANUpdated Feb 18, 2026

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

An observational study in Sepsis, Sepsis and Septic Shock and Sepsis at Intensive Care Unit, sponsored by Region Örebro County. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-18.

Primary conditionShock, SepticRegistry: SepsisReclassifiedWhy we changed it
Registry
Sepsis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Shock, Septic
Why
  1. The study's listed conditions name Shock, Septic, a narrower term within Sepsis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Region Örebro County · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
46
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Sepsis
  • Sepsis and Septic Shock
  • Sepsis at Intensive Care Unit
  • Intensive Care Nurses

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Keywords

  • sepsis
  • intensive care
  • ultrasound
  • venous congestion
  • VExUS
  • intensive care nurse
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In context

Shock, Septic Reclassified

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's planned enrollment of 46 is below the median of 108 across 406 observational studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Region Örebro County is the lead sponsor of 124 studies on the registry; 29 are open to participants now.

Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
46 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Intensive care patients

    Intensive care patients with sepsis

    Diagnostic Test: Hemodynamic diagnostic ultrasound of venous congestion

Interventions

  • BehavioralEducation in performing hemodynamic diagnostic ultrasound of venous congestion

    Educational program in performing hemodynamic diagnostic ultrasound of venous congestion

  • Diagnostic testHemodynamic diagnostic ultrasound of venous congestion

    Hemodynamic diagnostic ultrasound of venous congestion

    Also known as: VeXUS

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What researchers measure

Primary outcomes

  1. Intensive care nurses' VExUS performance

    Intensive care nurses' performance, regarding ultrasound image quality and assessment of ultrasound images according to VExUS protocol, evaluated by two experts.

    Time frame: two years

Secondary outcomes

  1. Intra-rater VExUS reliability

    Agreement of assessments of prior collected ultrasound images, according to VExUS protocol, performed by the same intensive care nurse.

    Time frame: two years

  2. Inter-rater VExUS reliability

    Agreement of assessments of prior collected ultrasound images according to VExUS protocol performed by different intensive care nurses.

    Time frame: two years

  3. Inter-rater VExUS image agreement

    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.

    Time frame: two years

  4. Venous congestion measured by VExUS and fluid status

    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.

    Time frame: two years

  5. Venous congestion measured by VExUS and clinical outcomes

    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.

    Time frame: two years

  6. Intensive care nurses' self-efficacy, confidence and experiences

    Differences in intensive care nurses' perceived self-efficacy and confidence at various time points during data collection, along with their experiences.

    Time frame: two years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07406750
Collaborators
Örebro University, Sweden, Region Östergötland, Dalarna County Council, Sweden
Responsible party
Sponsor
First posted
Feb 12, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Jan 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Feb 18, 2026

Study contacts

Johanna Savilampi, MD
Contact
johanna.savilampi@regionorebrolan.se
+46 019 6060266

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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