NCT07406750

Brief 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.

Trial Health

65
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Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Apr 2026

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026May 2027

First Submitted

Initial submission to the registry

November 25, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

February 18, 2026

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

November 25, 2025

Last Update Submit

February 13, 2026

Conditions

Keywords

sepsisintensive careultrasoundvenous congestionVExUSintensive care nurse

Outcome Measures

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.

    two years

Secondary Outcomes (6)

  • Intra-rater VExUS reliability

    two years

  • Inter-rater VExUS reliability

    two years

  • Inter-rater VExUS image agreement

    two years

  • Venous congestion measured by VExUS and fluid status

    two years

  • Venous congestion measured by VExUS and clinical outcomes

    two years

  • +1 more secondary outcomes

Study Arms (2)

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

Educational program in performing hemodynamic diagnostic ultrasound of venous congestion

Intensive care nurse

Hemodynamic diagnostic ultrasound of venous congestion

Also known as: VeXUS
Intensive care patients

Eligibility Criteria

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

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SepsisShock, SepticHyperemia

Interventions

Educational Status

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

February 12, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

February 18, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share