Actively Recruiting

Age: 18Years +
All Genders
ID06793020

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

Led by Vilnius University · Updated on 2025-01-27

100

Participants Needed

2

Research Sites

206 weeks

Total Duration

On this page

Sponsors

V

Vilnius University

Lead Sponsor

V

Vilnius University Hospital Santaros Klinikos

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether a new integrated mathematical model can improve the accuracy of diagnosing septic cardiomyopathy and predicting clinical outcomes in adults with suspected septic cardiomyopathy. This multicenter, prospective observational study focuses on patients treated for sepsis or septic shock in intensive care units. The aim is to see if combining clinical and echocardiographic data into one cardiovascular estimate enhances diagnosis and outcome prediction compared to the standard method. Adult patients meeting specific sepsis and septic shock criteria will undergo a primary transthoracic echocardiography within 48 hours of enrollment, alongside hemodynamic measurements. A second echocardiography will be performed within 10 days during ongoing ICU care or hospital ward stay, depending on patient progress. Data from both evaluations will be used in the integrated model to assess its diagnostic and predictive value. After hospital discharge, participants will be followed for up to one year, including completing a quality of life questionnaire (SF-36). Researchers will monitor overall health, functional status, healthcare visits, and nursing care needs to understand the long-term effects of septic cardiomyopathy. The study's main outcome is comparing the incidence of septic cardiomyopathy diagnosed by the new model versus the standard left ventricular ejection fraction method over this period.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Sepsis according to SEPSIS-3 criteria with suspected or confirmed infection and SOFA score 6 2 or qSOFA score 6 2
  • Septic shock as defined by SEPSIS-3 with sepsis diagnosis, vasopressor infusion to maintain MAP 6 65 mmHg, and lactate > 2 mmol/l
  • Requirement for cardiovascular support with norepinephrine infusion > 0.1 mcg/kg/min
  • Signed informed consent form (ICF)
Not Eligible

You will not qualify if you...

  • Individuals under 18 years of age
  • Uncompensated cardiovascular disease including cardiogenic shock, congenital heart disease, or heart failure NYHA functional class IV
  • Refusal to participate in the study

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Trial Site Locations

Total: 2 locations

1

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Actively Recruiting

2

University Clinical Centre of the Medical University of Warsaw

Warsaw, Poland

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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