NCT06343519

Brief Summary

Shocked patients require prompt and accurate assessment of their hemodynamic status to guide appropriate management. Echocardiography is a valuable tool for assessing cardiac function, while laboratory parameters such as mixed venous oxygen saturation and arterial blood lactate provide insights into tissue perfusion and oxygen metabolism. This study aims to compare echocardiographic findings, including cardiac index, speckle tracking parameters, and tissue Doppler indices, with laboratory findings in the evaluation of hemodynamic monitoring in shocked patients.

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 May 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

March 6, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

March 6, 2024

Last Update Submit

March 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Shock Status After Fluid Therapy Based on Echocardiographic Assessment of Fluid Responsiveness

    Change in shock status will be assessed 24 hours after initiation of fluid therapy by echocardiographic evaluation of cardiac index in liters per minute per square meter (L/min/m2).

    24 hours

Interventions

Measuring echocardiographic parameters (cardiac index, speckle tracking, tissue Doppler indices)

Eligibility Criteria

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

Adult patients (age \>18 years) presenting with shock admitted to the intensive care unit.

You may qualify if:

  • Patients diagnosed with shock based on clinical criteria (e.g., hypotension, signs of tissue hypoperfusion) requiring hemodynamic monitoring.
  • Patients age \> 18 year old.

You may not qualify if:

  • Patients with pre-existing cardiac conditions affecting echocardiographic parameters, those receiving mechanical circulatory support.
  • Patients with contraindications to echocardiography or blood sampling.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jardin F, Fourme T, Page B, Loubieres Y, Vieillard-Baron A, Beauchet A, Bourdarias JP. Persistent preload defect in severe sepsis despite fluid loading: A longitudinal echocardiographic study in patients with septic shock. Chest. 1999 Nov;116(5):1354-9. doi: 10.1378/chest.116.5.1354.

    PMID: 10559099BACKGROUND

MeSH Terms

Conditions

Shock

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Dina Ahmed

    Assiut University

    STUDY DIRECTOR
  • Mohamed Maghraby

    Assiut University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2024

First Posted

April 2, 2024

Study Start

May 1, 2024

Primary Completion

March 1, 2026

Study Completion

May 1, 2026

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share