RecruitingNCT06793020

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

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


Sponsor

Vilnius University

Enrollment

100 participants

Start Date

Mar 17, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • 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 Criteria6

  • 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.

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Locations(2)

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

University Clinical Centre of the Medical University of Warsaw

Warsaw, Poland

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NCT06793020


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