An observational study in Sepsis and Septic Shock Hyperdynamic, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Shanghai Zhongshan Hospital · Observational
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.
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.
1,956 studies on the registry are indexed under Sepsis; 477 are open to participants now.
This study's planned enrollment of 215 is above the median of 160 across 964 observational studies indexed under Sepsis.
Browse Sepsis studies →Shanghai Zhongshan Hospital is the lead sponsor of 651 studies on the registry; 290 are open to participants now.
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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.
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Exclusion Criteria:
Organ Support-Free Days Through Day 28
Time frame: From ICU admission through day 28
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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