Clinical trial NCT06793020: Diagnosis, Treatment, and Outcome Assessment of Septic Cardiomyopathy Using an Integrated Mathematical Model
Official title: Use of an Integrated Mathematical Model for the Diagnosis, Treatment and Outcome Assessment of Septic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Septic Cardiomyopathy
Keywords: Septic cardiomyopathy
Sepsis
Septic shock
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Vilnius University Hospital Santaros Klinikos
First posted: 2025-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for sepsis or septic shock in the Intensive Care Units of two university hospitals.

Brief summary: 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.

Detailed description: 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\&amp;#39; 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older;
* Sepsis according to SEPSIS-3 criteria:
* Suspected/confirmed infection and
* SOFA (Sequential Organ Failure Assessment) score ≥ 2 or qSOFA score ≥ 2;
* Septic shock according to SEPSIS-3 criteria:
* Sepsis is diagnosed and
* Vasopressor infusion is used to maintain a mean arterial pressure (MAP) ≥ 65 mmHg and
* Lactate \&gt; 2 mmol/l;
* Cardiovascular support requirement for norepinephrine \&gt; 0.1 mcg/kg/min infusion;
* Signed informed consent form (ICF);

Exclusion Criteria:

* Individuals under 18 years of age;
* Has uncompensated cardiovascular disease:
* Cardiogenic shock;
* Congenital heart disease;
* Heart failure NYHA functional class IV;
* Refusal to participate in the study.

Primary outcomes:
measure: Incidence of septic cardiomyopathy when comparing a new clinical-echocardiographic model with the standard diagnostic method (left ventricular ejection fraction).
timeFrame: From enrollment to the end of one-year follow-up.
Secondary outcomes:
measure: Assessing the severity of septic cardiomyopathy and determining the severity grade.
timeFrame: From enrollment to the end of one-year follow-up.
measure: Length of intensive care unit and hospital stay
timeFrame: 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.
measure: Mortality
timeFrame: Within 1 year of inclusion
measure: Recovery of cardiac function
timeFrame: Within 30 days of inclusion
measure: Long-term health and functional outcomes
timeFrame: Within 1 year of inclusion
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Warsaw
country: Poland
facility: University Clinical Centre of the Medical University of Warsaw
Study officials:
References: