Septic ShockALARMSNCT06832436
Atrial Strain in Septic Shock
An observational study of Septic Shock and Left Atrial Strain, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Left Atrial Strain, Right Atrial Strain
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2025to Sep 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to critical care for septic shock (SEPSIS-3 definition)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Amiens
Salouël, 80480
Christophe Beyls, MD, 33 + 03 22 08 78 66, beyls.christophe@chu-amiens.fr
About this study
Official title: 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.
- Conditions
- Septic Shock, Left Atrial Strain, Right Atrial Strain, Transthoracic Echocardiography, Speckle Tracking, Echocardiographic Software
- Keywords
- transthoracic echocardiography, septic shock, left atrial strain, right atrial strain, speckle tracking, echocardiographic software, AutoStrain, Bland-Altman analysis, reproducibility, critical care
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of LASr between ECOPAC and UWS
Agreement of LAS Reservoir Phase (LASr) measurement in manual mode between ECHOPAC and UWS
Measured: 1 year
Secondary outcomes (20)
variation of LAScd between ECHOPAC and UWS
Comparison of LAS Conduit (LAScd) measurements in manual mode between ECHOPAC and UWS
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Comparison of LAS in AutoStrain versus manual mode
Comparison of LAS measurements in AutoStrain versus manual mode on UWS
Measured: 1 year
Comparison of RAS in AutoStrain versus manual mode
Comparison of RAS measurements in AutoStrain versus manual mode on UWS
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start6 Mar 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Henri Mondor University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832436
- Sponsor's protocol ID
- PI2025_843_0034
- Acronym
- ALARMS
- Status last verified
- Jan 2026
- First submitted
- 11 Feb 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Left And Right Atrial Strain in Septic Shock
- ClinicalTrials.gov ID
- NCT06832436
- Acronym / sponsor ID
- ALARMS / PI2025_843_0034
- Conditions
- Septic Shock, Left Atrial Strain, Right Atrial Strain, Transthoracic Echocardiography, Speckle Tracking, Echocardiographic Software
- Keywords
- transthoracic echocardiography, septic shock, left atrial strain, right atrial strain, speckle tracking, echocardiographic software, AutoStrain, Bland-Altman analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Henri Mondor University Hospital
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 18 Feb 2025 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to critical care for septic shock (SEPSIS-3 definition)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
variation of LASr between ECOPAC and UWS
Time frame: 1 year
Agreement of LAS Reservoir Phase (LASr) measurement in manual mode between ECHOPAC and UWS
20 secondary outcomes
variation of LAScd between ECHOPAC and UWS
Time frame: 1 year
variation of LASct between ECHOPAC and UWS
Time frame: 1 year
Comparison of LASr measurements in apical 2-chamber views
Time frame: 1 year
Comparison of LAScd measurements in apical 2-chamber views
Time frame: 1 year
Comparison of LASct measurements in apical 2-chamber views
Time frame: 1 year
Comparison of right atrial strain RASr between ECHOPAC and UWS
Time frame: 1 year
Comparison of right atrial strain RAScd between ECHOPAC and UWS
Time frame: 1 year
Comparison of right atrial strain RASct between ECHOPAC and UWS
Time frame: 1 year
Comparison of LAS in AutoStrain versus manual mode
Time frame: 1 year
Comparison of RAS in AutoStrain versus manual mode
Time frame: 1 year
Comparison of LAS measurements in AutoStrain (UWS) versus manual mode on ECHOPAC
Time frame: 1 year
Comparison of RAS measurements in AutoStrain (UWS) versus manual mode on ECHOPAC
Time frame: 1 year
Assessment of differences in LAS measurements at end-diastole between ECHOPAC and UWS
Time frame: 1 year
Assessment of differences in LAS measurements at pre-A between ECHOPAC and UWS
Time frame: 1 year
Assessment of differences in RAS measurements at end-diastole between ECHOPAC and UWS
Time frame: 1 year
Assessment of differences in RAS measurements at pre-A between between ECHOPAC and UWS
Time frame: 1 year
Inter-observer reproducibility assessment of manual measurements (UWS and GE) in a sample of 10 patients
Time frame: 1 year
Intra-observer reproducibility assessment of manual measurements (UWS and GE) in a sample of 10 patients
Time frame: 1 year
Inter-observer reproducibility assessment of AutoStrain measurements (UWS and GE) in a sample of 10 patients
Time frame: 1 year
Intra-observer reproducibility assessment of AutoStrain measurements (UWS and GE) in a sample of 10 patients
Time frame: 1 year
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 16 Jan 2026.
- Individual participant dataSharing planned: No
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Sepsis
Not yet recruiting
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Acute Kidney Injury Due to Sepsis
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
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Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.
Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Left Atrial Strain, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Christophe Beyls, MD (33+322087866, beyls.christophe@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of LASr between ECOPAC and UWS (time frame: 1 year). 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 16 Jan 2026.