Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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.
Descripción general del estudio
Estado
Estado
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Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
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Criterio de elegibilidad
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Edades elegibles para estudiar
Acepta Voluntarios Saludables
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Método de muestreo
Población de estudio
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.
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Organ Support-Free Days Through Day 28
Periodo de tiempo: From ICU admission through day 28
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From ICU admission through day 28
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
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Inicio del estudio
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Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
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Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- Myocardial Work in Sepsis
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