SepsisNCT07915869
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
An observational study of Sepsis and Septic Shock Hyperdynamic, run by Shanghai Zhongshan Hospital.
Trial summary
This prospective, single-center observational cohort study aims to investigate the feasibility, reproducibility, and longitudinal trajectory patterns of left ventricular myocardial work in adult patients with sepsis during the early phase of intensive care unit (ICU) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock Hyperdynamic
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2029
- 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
- Adult, Older adult
Study population: Adult patients admitted to the participating intensive care unit who meet Sepsis-3 criteria within 12 hours of admission, have an arterial catheter placed for clinical indications, and are eligible for early echocardiographic assessment.
Who may be able to join
- Age 18 years or older and admitted to the participating intensive care unit.
- Diagnosis of sepsis according to Sepsis-3 criteria, defined as an acute increase in the Sequential Organ Failure Assessment (SOFA) score of at least 2 points attributable to infection, within 12 hours of ICU admission.
- An arterial catheter placed for clinical indications and available at the first assessment, without additional catheter placement solely for research purposes.
- Eligible for an attempt at echocardiographic data acquisition within 0-12 hours after ICU admission. Technical success of the initial myocardial work assessment is not required for enrollment.
- Written informed consent obtained from the participant or a legally authorized representative before initiation of study procedures.
Who cannot join
- ICU admission following cardiac surgery, including coronary artery bypass grafting, valve surgery, or other cardiac procedures that substantially alter cardiac mechanical function.
- Receipt of mechanical circulatory support, including ECMO, intra-aortic balloon pump, or Impella, before enrollment.
- Moderate-to-severe aortic stenosis, significant left ventricular outflow tract obstruction, severe aortic regurgitation, severe mitral regurgitation, or other structural abnormalities that substantially compromise the interpretation of myocardial work.
- A decision at enrollment to provide comfort measures only without active resuscitation.
- Pregnancy.
- Inability to obtain informed consent through an ethics committee-approved consent procedure.
About this study
Official title: A Prospective Observational Study on the Longitudinal Trajectory Phenotype of Myocardial Work in Patients With Sepsis
This prospective, single-center observational cohort study aims to investigate the feasibility, reproducibility, and longitudinal trajectory patterns of left ventricular myocardial work in adult patients with sepsis during the early phase of intensive care unit (ICU) treatment.
A total of 215 patients will be enrolled. Myocardial work indices, including global work efficiency (GWE), global work index (GWI), global constructive work (GCW), and global wasted work (GWW), will be assessed at approximately 12, 24, and 72 hours after ICU admission. Latent trajectory classes of GWE will be explored, and their internal stability will be evaluated.
The association between GWE trajectory classes and organ support-free days through day 28 will be assessed in a prespecified 84-hour landmark population. All treatment decisions will be made independently by the clinical team, and study-derived myocardial work measurements will not guide clinical management.
Read the detailed description
Sepsis is associated with complex and dynamic changes in myocardial function, vascular tone, loading conditions, and hemodynamic status. Conventional echocardiographic indices, such as left ventricular ejection fraction and global longitudinal strain, are influenced by loading conditions and may not adequately characterize early changes in myocardial performance.
Myocardial work assessment combines longitudinal myocardial strain with an estimated left ventricular pressure curve to generate pressure-strain loops. This approach provides indices including global work index, global constructive work, global wasted work, and global work efficiency.
This prospective, single-center observational cohort study will consecutively screen adult patients who meet Sepsis-3 criteria within 12 hours of ICU admission and have an arterial catheter placed for clinical indications.
Echocardiographic images and synchronized hemodynamic data will be collected during three predefined assessment windows: 0-12 hours (T1), 20-28 hours (T2), and 60-84 hours (T3) after ICU admission. Myocardial work indices will be obtained through offline analysis of echocardiographic images. Clinical information, laboratory results, vasoactive medication use, and organ support will also be recorded.
Group-based trajectory modeling or latent class growth analysis will be used to explore one to three potential longitudinal GWE trajectory classes. Class identifiability and internal stability will be assessed using model diagnostics and patient-level bootstrap resampling.
For clinical association analyses, the prespecified 84-hour landmark population will be used to evaluate the relationship between stable GWE trajectory classes and organ support-free days through day 28. Secondary analyses will examine mortality, organ support outcomes, and dynamic relationships between myocardial work indices and hemodynamic measurements.
The study will not assign treatments, alter clinical management, require additional blood sampling, or require additional arterial catheterization. All clinical investigations and echocardiographic examinations will be performed within routine clinical care.
- Conditions
- Sepsis, Septic Shock Hyperdynamic
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ Support-Free Days Through Day 28
Measured: From ICU admission through day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915869
- Sponsor's protocol ID
- Myocardial Work in Sepsis
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Longitudinal Trajectory Phenotype of Myocardial Work in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT07915869
- Acronym / sponsor ID
- Myocardial Work in Sepsis
- Conditions
- Sepsis, Septic Shock Hyperdynamic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Nov 2026 (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.
This prospective, single-center observational cohort study aims to investigate the feasibility, reproducibility, and longitudinal trajectory patterns of left ventricular myocardial work in adult patients with sepsis during the early phase of intensive care unit (ICU) treatment.
A total of 215 patients will be enrolled. Myocardial work indices, including global work efficiency (GWE), global work index (GWI), global constructive work (GCW), and global wasted work (GWW), will be assessed at approximately 12, 24, and 72 hours after ICU admission. Latent trajectory classes of GWE will be explored, and their internal stability will be evaluated.
The association between GWE trajectory classes and organ support-free days through day 28 will be assessed in a prespecified 84-hour landmark population. All treatment decisions will be made independently by the clinical team, and study-derived myocardial work measurements will not guide clinical management.
Detailed description
Sepsis is associated with complex and dynamic changes in myocardial function, vascular tone, loading conditions, and hemodynamic status. Conventional echocardiographic indices, such as left ventricular ejection fraction and global longitudinal strain, are influenced by loading conditions and may not adequately characterize early changes in myocardial performance.
Myocardial work assessment combines longitudinal myocardial strain with an estimated left ventricular pressure curve to generate pressure-strain loops. This approach provides indices including global work index, global constructive work, global wasted work, and global work efficiency.
This prospective, single-center observational cohort study will consecutively screen adult patients who meet Sepsis-3 criteria within 12 hours of ICU admission and have an arterial catheter placed for clinical indications.
Echocardiographic images and synchronized hemodynamic data will be collected during three predefined assessment windows: 0-12 hours (T1), 20-28 hours (T2), and 60-84 hours (T3) after ICU admission. Myocardial work indices will be obtained through offline analysis of echocardiographic images. Clinical information, laboratory results, vasoactive medication use, and organ support will also be recorded.
Group-based trajectory modeling or latent class growth analysis will be used to explore one to three potential longitudinal GWE trajectory classes. Class identifiability and internal stability will be assessed using model diagnostics and patient-level bootstrap resampling.
For clinical association analyses, the prespecified 84-hour landmark population will be used to evaluate the relationship between stable GWE trajectory classes and organ support-free days through day 28. Secondary analyses will examine mortality, organ support outcomes, and dynamic relationships between myocardial work indices and hemodynamic measurements.
The study will not assign treatments, alter clinical management, require additional blood sampling, or require additional arterial catheterization. All clinical investigations and echocardiographic examinations will be performed within routine clinical care.
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
- Adult patients admitted to the participating intensive care unit who meet Sepsis-3 criteria within 12 hours of admission, have an arterial catheter placed for clinical indications, and are eligible for early echocardiographic assessment.
Key inclusion criteria (5 listed)
- Age 18 years or older and admitted to the participating intensive care unit.
- Diagnosis of sepsis according to Sepsis-3 criteria, defined as an acute increase in the Sequential Organ Failure Assessment (SOFA) score of at least 2 points attributable to infection, within 12 hours of ICU admission.
- An arterial catheter placed for clinical indications and available at the first assessment, without additional catheter placement solely for research purposes.
- Eligible for an attempt at echocardiographic data acquisition within 0-12 hours after ICU admission. Technical success of the initial myocardial work assessment is not required for enrollment.
- Written informed consent obtained from the participant or a legally authorized representative before initiation of study procedures.
Key exclusion criteria (6 listed)
- ICU admission following cardiac surgery, including coronary artery bypass grafting, valve surgery, or other cardiac procedures that substantially alter cardiac mechanical function.
- Receipt of mechanical circulatory support, including ECMO, intra-aortic balloon pump, or Impella, before enrollment.
- Moderate-to-severe aortic stenosis, significant left ventricular outflow tract obstruction, severe aortic regurgitation, severe mitral regurgitation, or other structural abnormalities that substantially compromise the interpretation of myocardial work.
- A decision at enrollment to provide comfort measures only without active resuscitation.
- Pregnancy.
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
Organ Support-Free Days Through Day 28
Time frame: From ICU admission through day 28
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 4 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock Hyperdynamic, run by Shanghai Zhongshan Hospital.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Organ Support-Free Days Through Day 28 (time frame: From ICU admission through day 28). 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 4 Nov 2026.