Atrial Strain in Septic Shock (ALARMS)

Assessment of Left And Right Atrial Strain in Septic Shock

Septic shock is a critical condition associated with high mortality. Transthoracic echocardiography is widely used to evaluate cardiac function and guide treatment. Left and right atrial strain (LAS and RAS) measured via speckle tracking echocardiography have shown prognostic value in cardiovascular diseases. However, differences exist between echocardiographic software, leading to challenges in result comparability. This study aims to compare LAS and RAS measurements between ECHOPAC and UWS software, evaluate AutoStrain technology, and assess reproducibility across observers. The study is non-interventional and will use retrospective echocardiographic data from patients treated for septic shock. The findings will contribute to improving measurement standardization in critically ill patients.

Study Overview

• Status: Recruiting
• Conditions: Septic Shock; Critical Care; Transthoracic Echocardiography; Speckle Tracking; Reproducibility; Left Atrial Strain; Right Atrial Strain; Echocardiographic Software

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Christophe Beyls, MD; Phone Number: 33+322087866; Email: beyls.christophe@chu-amiens.fr

Study Locations

• France
  • Salouël, France, 80480
    • Recruiting
    • CHRU Amiens
    • Contact: Christophe Beyls, MD; Phone Number: 33 + 03 22 08 78 66; Email: beyls.christophe@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to critical care for septic shock (SEPSIS-3 definition)

Description

Inclusion Criteria:

• Age: >18 years
• Adult patients admitted to critical care for septic shock (SEPSIS-3 definition)
• TTE performed as part of medical management
• No objection to data usage

Exclusion Criteria:

• Pregnancy
• Moderate to severe valvular regurgitation/stenosis (>grade 2)
• Ventricular or supraventricular tachyarrhythmia (HR >140 bpm) at the time of TTE
• Poor echogenicity preventing LAS measurement
• Mechanical circulatory support
• Pacemaker dependence
• Patients under guardianship

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variation of LASr between ECOPAC and UWS	Agreement of LAS Reservoir Phase (LASr) measurement in manual mode between ECHOPAC and UWS	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variation of LAScd between ECHOPAC and UWS	Comparison of LAS Conduit (LAScd) measurements in manual mode between ECHOPAC and UWS	1 year
variation of LASct between ECHOPAC and UWS	Comparison of LAS Conduit (LAScd) and Contraction (LASct) measurements in manual mode between ECHOPAC and UWS	1 year
Comparison of LASr measurements in apical 2-chamber views	Comparison of LASr measurements in apical 2-chamber views in manual mode between ECHOPAC and UWS	1 year
Comparison of LAScd measurements in apical 2-chamber views	Comparison of LAScd measurements in apical 2-chamber views in manual mode between ECHOPAC and UWS	1 year
Comparison of LASct measurements in apical 2-chamber views	Comparison of LASct measurements in apical 2-chamber views in manual mode between ECHOPAC and UWS	1 year
Comparison of right atrial strain RASr between ECHOPAC and UWS	Comparison of right atrial strain (RASr) in manual mode between ECHOPAC and UWS	1 year
Comparison of right atrial strain RAScd between ECHOPAC and UWS	Comparison of right atrial strain RAScd in manual mode between ECHOPAC and UWS	1 year
Comparison of right atrial strain RASct between ECHOPAC and UWS	Comparison of right atrial strain RASct in manual mode between ECHOPAC and UWS	1 year
Comparison of LAS in AutoStrain versus manual mode	Comparison of LAS measurements in AutoStrain versus manual mode on UWS	1 year
Comparison of RAS in AutoStrain versus manual mode	Comparison of RAS measurements in AutoStrain versus manual mode on UWS	1 year
Comparison of LAS measurements in AutoStrain (UWS) versus manual mode on ECHOPAC	Comparison of LAS measurements in AutoStrain (UWS) versus manual mode on ECHOPAC	1 year
Comparison of RAS measurements in AutoStrain (UWS) versus manual mode on ECHOPAC	Comparison of RAS measurements in AutoStrain (UWS) versus manual mode on ECHOPAC	1 year
Assessment of differences in LAS measurements at end-diastole between ECHOPAC and UWS	Assessment of differences in LAS phase measurements between ECHOPAC and UWS	1 year
Assessment of differences in LAS measurements at pre-A between ECHOPAC and UWS	Assessment of differences in LAS measurements at pre-A between ECHOPAC and UWS	1 year
Assessment of differences in RAS measurements at end-diastole between ECHOPAC and UWS	Assessment of differences in RAS measurements at end-diastole between ECHOPAC and UWS	1 year
Assessment of differences in RAS measurements at pre-A between between ECHOPAC and UWS	Assessment of differences in RAS measurements at pre-A between between ECHOPAC and UWS	1 year
Inter-observer reproducibility assessment of manual measurements (UWS and GE) in a sample of 10 patients	Inter-observer reproducibility assessment of manual measurements (UWS and GE) in a sample of 10 patients	1 year
Intra-observer reproducibility assessment of manual measurements (UWS and GE) in a sample of 10 patients	Intra-observer reproducibility assessment of manual measurements (UWS and GE) in a sample of 10 patients	1 year
Inter-observer reproducibility assessment of AutoStrain measurements (UWS and GE) in a sample of 10 patients	Inter-observer reproducibility assessment of AutoStrain measurements (UWS and GE) in a sample of 10 patients	1 year
Intra-observer reproducibility assessment of AutoStrain measurements (UWS and GE) in a sample of 10 patients	Intra-observer reproducibility assessment of AutoStrain measurements (UWS and GE) in a sample of 10 patients	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Henri Mondor University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: septic shock; critical care; transthoracic echocardiography; speckle tracking; reproducibility; left atrial strain; right atrial strain; echocardiographic software; AutoStrain; Bland-Altman analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic
• Other Study ID Numbers: PI2025_843_0034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No