An observational study in Septic Cardiomyopathy, sponsored by Vilnius University. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Vilnius University · Observational
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.
This multicenter, prospective observational study will enrol adult patients treated for sepsis or septic shock in the intensive care unit (ICU). Eligible patients will be identified based on predefined inclusion and exclusion criteria and enrolled in the study after obtaining informed consent. The primary transthoracic echocardiography will be performed within 48 hours of enrollment to gather detailed echocardiographic data, while key hemodynamic measurements will be recorded simultaneously.
A second transthoracic echocardiography will be conducted within 10 days of the initial evaluation. This follow-up assessment will occur during continued ICU care after discontinuation of vasopressor therapy or during hospitalization in the general ward, depending on the patient's clinical progression. The echocardiographic and hemodynamic parameters from both the initial and follow-up evaluations will be input into a mathematical formula designed to integrate these data into a single cardiovascular estimate. This integrated model will then be used to assess its ability to predict patient outcomes.
Following hospital discharge, patients will be followed for up to one year. During this period, a long-term follow-up assessment will be conducted, during which patients will complete the SF-36 quality of life questionnaire. This follow-up will assess patients\' overall health, functional status, frequency of healthcare visits, and need for nursing care. These data will provide insights into the long-term impact of sepsis and septic cardiomyopathy on survivors beyond the acute phase of their illness.
This study will evaluate whether the use of an integrated model that combines clinical parameters with echocardiographic measurements can improve the accuracy of diagnosing septic cardiomyopathy and provide valuable predictions of clinical outcomes. Additionally, the study will assess the course of septic cardiomyopathy and its impact on one-year follow-up outcomes, including patient quality of life. A broadly applicable diagnostic approach could allow for timely treatment adjustments, reduce the burden of sepsis-related complications, and improve overall patient outcomes.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Vilnius University is the lead sponsor of 61 studies on the registry; 11 are open to participants now.
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Patients treated for sepsis or septic shock in the Intensive Care Units of two university hospitals.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Mortality
Mortality during intensive care unit stay, in hospital and at 1 year
Time frame: Within 1 year of inclusion
Recovery of cardiac function
Changes in the integrated mathematical model during hospitalization
Time frame: Within 30 days of inclusion
Long-term health and functional outcomes
Heath-related quality of life assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). Assessment of changes in functional capacity, number of visits to healthcare facilities, and the need for nursing care.
Time frame: Within 1 year of inclusion
Plan to share: No
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Vilnius University