Shock, SepticSepsistrainNCT03663192
Strain Echocardiography During Septic Shock : an Observational Pilot Study
An observational study of Shock, Septic and Echocardiography, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The mortality of septic shock remains high nowadays despite a trend toward improvement.Septic cardiomyopathy has been reported in most experimental models of sepsis shock. Its relationship with mortality is unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Septic, Echocardiography
- What is being tested?
- strain echocardiography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2016to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: ICU patients
Who may be able to join
- Septic shock (suspected or proven infection and norepinephrine ≥ 0,25µg/kg/min)
Who cannot join
- Patient < 18 year of age
- Pregnant women
- History of myocardial infarction, valvular disease, atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
The mortality of septic shock remains high nowadays despite a trend toward improvement.Septic cardiomyopathy has been reported in most experimental models of sepsis shock. Its relationship with mortality is unclear. A decrease in mortality have been reported in patients with decreased left ventricular ejection fraction (LVEF), but a recent meta-analysis did not support such results. In fact, it appears that high LVEF are linked to profound vasoplegia which is associated to bad outcome.
In the other hand, alterations of Strain echocardiography, a new method allowing a more sensitive evaluation of heart function, have been associated with a worse outcome in sepsis patients. Only few studies have examined echocardiographic strain during sepsis shock in human, and its natural history was only described in pigs. Moreover, the right ventricular strain was reported only by Orde et al whereas the evolution of strain during fluid infusion have never been studied. The aim of the present study is to describe the natural history of echocardiographic strain during sepsis shock and to determine its prognosis value.
- Conditions
- Shock, Septic, Echocardiography
- Being tested
- strain echocardiography
- Keywords
- Shock, Septic, Echocardiography, speckle tracking, strain
- Medical subject headings
- Shock, Septic, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strain echocardiographyDevice
strain echocardiography during septic shock
What is being measured
The primary outcome is the main question the study is designed to answer.
Global peak systolic longitudinal strain assessed by echocardiography. Global peak systolic longitudinal strain
Measured: up to 90 days
Secondary outcomes (1)
ICU mortality
On the day of patient discharge from the ICU
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start22 Feb 2016
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shock, SepticStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Roger, MD,PhD, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663192
- Sponsor's protocol ID
- IRB : 16.02.07
- Acronym
- Sepsistrain
- Status last verified
- May 2019
- First submitted
- 5 Apr 2018
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bazalgette F, Roger C, Louart B, Daurat A, Bobbia X, Lefrant JY, Muller L. Prognostic value and time course evolution left ventricular global longitudinal strain in septic shock: an exploratory prospective study. J Clin Monit Comput. 2021 Dec;35(6):1501-1510. doi: 10.1007/s10877-020-00620-w. Epub 2020 Nov 20.
PubMed 33216237
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strain Echocardiography During Septic Shock : an Observational Pilot Study
- ClinicalTrials.gov ID
- NCT03663192
- Acronym / sponsor ID
- Sepsistrain / IRB : 16.02.07
- Conditions
- Shock, Septic, Echocardiography
- Keywords
- Shock, Septic, Echocardiography, speckle tracking, strain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 10 Sep 2018 (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.
The mortality of septic shock remains high nowadays despite a trend toward improvement.Septic cardiomyopathy has been reported in most experimental models of sepsis shock. Its relationship with mortality is unclear. A decrease in mortality have been reported in patients with decreased left ventricular ejection fraction (LVEF), but a recent meta-analysis did not support such results. In fact, it appears that high LVEF are linked to profound vasoplegia which is associated to bad outcome.
In the other hand, alterations of Strain echocardiography, a new method allowing a more sensitive evaluation of heart function, have been associated with a worse outcome in sepsis patients. Only few studies have examined echocardiographic strain during sepsis shock in human, and its natural history was only described in pigs. Moreover, the right ventricular strain was reported only by Orde et al whereas the evolution of strain during fluid infusion have never been studied. The aim of the present study is to describe the natural history of echocardiographic strain during sepsis shock and to determine its prognosis value.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (1 listed)
- Septic shock (suspected or proven infection and norepinephrine ≥ 0,25µg/kg/min)
Key exclusion criteria (3 listed)
- Patient < 18 year of age
- Pregnant women
- History of myocardial infarction, valvular disease, atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| strain echocardiographystrain echocardiography during septic shock | Device | – |
Primary outcome
Global peak systolic longitudinal strain assessed by echocardiography. Global peak systolic longitudinal strain
Time frame: up to 90 days
1 secondary outcome
ICU mortality
Time frame: up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Results publication: PubMed 33216237Bazalgette F, Roger C, Louart B, Daurat A, Bobbia X, Lefrant JY, Muller L. Prognostic value and time course evolution left ventricular global longitudinal strain in septic shock: an exploratory prospective study. J Clin Monit Comput. 2021 Dec;35(6):1501-1510. doi: 10.1007/s10877-020-00620-w. Epub 2020 Nov 20.
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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. This study is not recruiting at the moment.
Claire Roger, MD,PhD principal investigator
CHU Nimes
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 Shock, Septic and Echocardiography, run by Centre Hospitalier Universitaire de Nīmes 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 1 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global peak systolic longitudinal strain assessed by echocardiography. Global peak systolic longitudinal strain (time frame: up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03663192, which also lists 1 linked publication.
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 1 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.