NCT06586931

Brief Summary

assessing septic patients with a noninvasive ultrasound protocol, and earlier identification of fluid overload to help clinicians decide whether to administer supplemental fluid therapy or suspend its administration and to evaluate the possible relation between the different VExUS grades and the adverse effects of intensive fluid administration

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

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

First Submitted

Initial submission to the registry

September 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 4, 2024

Last Update Submit

September 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • VEXUS score

    Assessment of fluid status in septic patients by VEXUS score

    Baseline

Secondary Outcomes (1)

  • Accuracy of CVP for assessment of fluid status in septic patients

    Baseline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients (≥ 18 years old) with the diagnosis of severe sepsis and clinical indication to be admitted in critical care units are recruited. Sepsis should be suspected to be the primary cause of their acute illness by the treating physician,

You may qualify if:

  • adult patients (≥ 18 years old) with the diagnosis of severe sepsis and clinical indication to be admitted in critical care units are recruited. Sepsis should be suspected to be the primary cause of their acute illness by the treating physician, consistent with the
  • Surviving Sepsis Campaign Guidelines (2021) :
  • Life-threatening organ dysfunction
  • Diagnosis of infection Some patients diagnosed with sepsis will not meet the criteria, but will be eligible for the study if the treating physician makes a clinical diagnosis of severe sepsis.

You may not qualify if:

  • \. Refusal to participate 2. Patients in hemodialysis program 3. Patients with previously known conditions that interfere with portal Doppler assessments, namely liver cirrhosis, or severe tricuspid regurgitation with structural heart disease. If any of these conditions are identified during the present episode, the patient would also be excluded.
  • \. Age \< 18 years 5. Patients subjected to withdrawal of care 6. Hemodynamic instability due to active hemorrhage 7. Acute coronary syndrome 8. Indication for immediate surgery 9. Received CPR within 24 hours of enrollment 10. Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Longino A, Martin K, Leyba K, Siegel G, Gill E, Douglas IS, Burke J. Correlation between the VExUS score and right atrial pressure: a pilot prospective observational study. Crit Care. 2023 May 26;27(1):205. doi: 10.1186/s13054-023-04471-0.

    PMID: 37237315BACKGROUND
  • Rola P, Miralles-Aguiar F, Argaiz E, Beaubien-Souligny W, Haycock K, Karimov T, Dinh VA, Spiegel R. Clinical applications of the venous excess ultrasound (VExUS) score: conceptual review and case series. Ultrasound J. 2021 Jun 19;13(1):32. doi: 10.1186/s13089-021-00232-8.

    PMID: 34146184BACKGROUND

Related Links

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jozef Zekry, Professor

    Minia U

    STUDY CHAIR

Central Study Contacts

Andrew Emad thabet

CONTACT

Mohamed Mostafa ali

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Accuracy of venous excess ultrasound (VEXUS) score versus central venous pressure to assess volume status in patients with severe sepsis

Study Record Dates

First Submitted

September 4, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09