Diagnosis, Treatment, and Outcome Assessment of Septic Cardiomyopathy Using an Integrated Mathematical Model

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVilnius University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of one-year follow-up.

Secondary outcomes

1

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.

Time frame
From enrollment to the end of one-year follow-up.
2

Length of intensive care unit and hospital stay

Total cumulative number of days spent in intensive care unit and hospital

Time frame
Intensive care unit days spent per patient: within 60 days following intensive care unit admission. Hospital days spent per patient: from admission up to 30 days.
3

Mortality

Mortality during intensive care unit stay, in hospital and at 1 year

Time frame
Within 1 year of inclusion
4

Recovery of cardiac function

Changes in the integrated mathematical model during hospitalization

Time frame
Within 30 days of inclusion

Other outcomes

Sponsors and contacts

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Vilnius University

Lead sponsor

Vilnius University Hospital Santaros Klinikos

Collaborator