About this trial
The goal of this observational study is to evaluate whether a new integrated mathematical model can improve the accuracy of diagnosing septic cardiomyopathy and predicting clinical outcomes in adult patients with suspected septic cardiomyopathy. The study aims to determine whether the integrated mathematical model enhances diagnostic accuracy and improves the prediction of clinical outcomes in these patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older;
Suspected/confirmed infection and
SOFA (Sequential Organ Failure Assessment) score ≥ 2 or qSOFA score ≥ 2;
Sepsis is diagnosed and
Disqualifiers
Individuals under 18 years of age;
Cardiogenic shock;
Congenital heart disease;
Heart failure NYHA functional class IV;
Trial population
Patients treated for sepsis or septic shock in the Intensive Care Units of two university hospitals.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incidence of septic cardiomyopathy when comparing a new clinical-echocardiographic model with the standard diagnostic method (left ventricular ejection fraction).
Incidence of septic cardiomyopathy, evaluated by comparing the diagnostic accuracy of a new clinical-echocardiographic model with the standard method, left ventricular ejection fraction (LVEF) measurement. The study will determine whether the new model improves the diagnosis of septic cardiomyopathy in patients with sepsis or septic shock.
Secondary outcomes
Assessing the severity of septic cardiomyopathy and determining the severity grade.
This will be done by applying clinical and echocardiographic data to the integrated mathematical model, which will then categorize the severity of the condition into predefined severity grades. The assessment aims to provide a more nuanced understanding of the diseases impact on cardiac function and to validate the models ability to stratify patients based on the severity of their condition.
Length of intensive care unit and hospital stay
Total cumulative number of days spent in intensive care unit and hospital
Mortality
Mortality during intensive care unit stay, in hospital and at 1 year
Recovery of cardiac function
Changes in the integrated mathematical model during hospitalization
Sponsors and contacts
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Vilnius University
Lead sponsor
Vilnius University Hospital Santaros Klinikos
Collaborator