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

NCT ID: NCT06793020

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-17
• Study Completion Date: 2028-03-31

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' 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.

Conditions

Septic Cardiomyopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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 > 2 mmol/l;
• Cardiovascular support requirement for norepinephrine > 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role: collaborator

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Tomas Jovaisa

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Site Status: RECRUITING

University Clinical Centre of the Medical University of Warsaw

Warsaw, , Poland

Site Status: RECRUITING

Countries

Lithuania; Poland

Facility Contacts

Tomas Jovaisa, Prof

Role: primary

tomas.jovaisa@santa.lt

+37062697567

Mateusz Zawadka, Dr

Role: primary

mateusz.zawadka@wum.edu.pl

+48505018394

Other Identifiers

2024/3-1574-1032

Identifier Type: OTHER

Identifier Source: secondary_id

2024-3-1574-1032

Identifier Type: -

Identifier Source: org_study_id