Improving diagnosis and outcomes of septic cardiomyopathy with a mathematical model

Use of an Integrated Mathematical Model for the Diagnosis, Treatment and Outcome Assessment of Septic Cardiomyopathy

This study is testing a new mathematical model to see if it can help doctors better diagnose septic cardiomyopathy and predict how well adult patients with sepsis will do after treatment.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vilnius University (Academic / other)
• Locations: 2 sites (Vilnius and 1 other locations)
• Trial ID: NCT06793020 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of a new integrated mathematical model in diagnosing septic cardiomyopathy and predicting clinical outcomes in adult patients with suspected septic cardiomyopathy. Conducted in multiple centers, the study will enroll patients treated for sepsis or septic shock in the ICU, performing echocardiography and hemodynamic measurements to gather essential data. The collected data will be analyzed using the mathematical model to assess its predictive capabilities. Patients will be followed for up to one year post-discharge to evaluate long-term health outcomes and quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with sepsis or septic shock according to SEPSIS-3 criteria.

Not a fit: Patients with uncompensated cardiovascular diseases or those under 18 years of age may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate diagnoses and better management of septic cardiomyopathy, ultimately improving patient outcomes.

How similar studies have performed: While the use of mathematical models in clinical settings is gaining traction, this specific approach to septic cardiomyopathy is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Vilnius and 1 other locations

• Vilnius University Hospital Santaros Klinikos — Vilnius, Lithuania (Recruiting)
• University Clinical Centre of the Medical University of Warsaw — Warsaw, Poland (Recruiting)

Conditions Septic Cardiomyopathy; Septic cardiomyopathy; Sepsis; Septic shock