Improving diagnosis and outcomes of septic cardiomyopathy with a mathematical model
Official title: Use of an Integrated Mathematical Model for the Diagnosis, Treatment and Outcome Assessment of Septic Cardiomyopathy
Run by Vilnius University · NCT06793020 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Vilnius University Academic / other |
| Locations | 2 sites (Vilnius and 1 other locations) |
| Status | Recruiting |
| Started | March 17, 2024 |
| Main results expected | March 2028 |
| Study ends | March 2028 |
| Registry record updated | January 27, 2025 |
| Trial ID | NCT06793020 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with sepsis or septic shock according to SEPSIS-3 criteria.
✕Probably not a fit
Patients with uncompensated cardiovascular diseases or those under 18 years of age may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania Recruiting -
University Clinical Centre of the Medical University of Warsaw
Warsaw, Poland Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using Shenfu Injection to Protect Heart Function in Septic Shock
This study tests if adding Shenfu Injection to regular treatment can help people with septic shock keep their hearts working better and recover faster.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.