SepsisVEXIVANNCT07406750
Hemodynamic Venous Congestion Ultrasound (VExUS) by ICU Nurses in Sepsis Patients.
An observational study of Sepsis and Sepsis and Septic Shock, run by Region Örebro County.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Sepsis and Septic Shock, Sepsis at Intensive Care Unit
- What is being tested?
- Education in performing hemodynamic diagnostic ultrasound of venous congestion and Hemodynamic diagnostic ultrasound of venous congestion
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 May 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Intensive care nurses with a specialist degree in intensive care and intensive care patients with sepsis.
Who may be able to join
- 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.
Who cannot join
- Intensive Care Nurses
- Personnel with primarily an administration position or less clinical duty at the ICU.
- Intensive Care Patients
- Patients with preexisting liver cirrhosis.
- Pregnancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Being tested
- Education in performing hemodynamic diagnostic ultrasound of venous congestion, Hemodynamic diagnostic ultrasound of venous congestion
- Keywords
- sepsis, intensive care, ultrasound, venous congestion, VExUS, intensive care nurse
- Medical subject headings
- Sepsis, Shock, Septic, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education in performing hemodynamic diagnostic ultrasound of venous congestionBehavioural
Educational program in performing hemodynamic diagnostic ultrasound of venous congestion
Hemodynamic diagnostic ultrasound of venous congestionDiagnostic test
Also called VeXUS
Hemodynamic diagnostic ultrasound of venous congestion
| Study group | Role | What they receive |
|---|---|---|
| Intensive care nurse | Intensive care nurses that perform hemodynamic diagnostic ultrasound acording to the VExUS protocol Receives: Behavioral: Education in performing hemodynamic diagnostic ultrasound of venous congestion | |
| Intensive care patients | Intensive care patients with sepsis Receives: Diagnostic Test: Hemodynamic diagnostic ultrasound of venous congestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Secondary outcomes (6)
Intra-rater VExUS reliability
Agreement of assessments of prior collected ultrasound images, according to VExUS protocol, performed by the same intensive care nurse.
Measured: two years
Inter-rater VExUS reliability
Agreement of assessments of prior collected ultrasound images according to VExUS protocol performed by different intensive care nurses.
Measured: two years
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.
Measured: two years
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.
Measured: two years
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.
Measured: two years
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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden, Region Östergötland, Dalarna County Council, Sweden
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406750
- Sponsor's protocol ID
- VEXIVAN01
- Other IDs
- CIV-25-05-052654
- Acronym
- VEXIVAN
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Diagnostic Ultrasound of Venous Congestion (VExUS) Performed by Intensive Care Nurses on Patients With Sepsis.
- ClinicalTrials.gov ID
- NCT07406750
- Acronym / sponsor ID
- VEXIVAN / VEXIVAN01
- Keywords
- sepsis, intensive care, ultrasound, venous congestion, VExUS, intensive care nurse
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Örebro University, Sweden, Region Östergötland, Dalarna County Council, Sweden
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 12 Feb 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive care nurse | – | Behavioral: Education in performing hemodynamic diagnostic ultrasound of venous congestionIntensive care nurses that perform hemodynamic diagnostic ultrasound acording to the VExUS protocol |
| Intensive care patients | – | Diagnostic Test: Hemodynamic diagnostic ultrasound of venous congestionIntensive care patients with sepsis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care nurses with a specialist degree in intensive care and intensive care patients with sepsis.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Intensive Care Nurses
- Personnel with primarily an administration position or less clinical duty at the ICU.
- Intensive Care Patients
- Patients with preexisting liver cirrhosis.
- Pregnancy.
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 |
|---|---|---|
| Education in performing hemodynamic diagnostic ultrasound of venous congestionEducational program in performing hemodynamic diagnostic ultrasound of venous congestion | Behavioural | Intensive care nurse |
| Hemodynamic diagnostic ultrasound of venous congestionAlso: VeXUSHemodynamic diagnostic ultrasound of venous congestion | Diagnostic test | Intensive care patients |
Primary outcome
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.
6 secondary outcomes
Intra-rater VExUS reliability
Time frame: two years
Inter-rater VExUS reliability
Time frame: two years
Inter-rater VExUS image agreement
Time frame: two years
Venous congestion measured by VExUS and fluid status
Time frame: two years
Venous congestion measured by VExUS and clinical outcomes
Time frame: two years
Intensive care nurses' self-efficacy, confidence and experiences
Time frame: two years
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 18 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Sepsis and Septic Shock, run by Region Örebro County.
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 5 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: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Johanna Savilampi, MD (+46 019 6060266, johanna.savilampi@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive care nurses' VExUS performance (time frame: two years). 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 18 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.