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

NCT06793020 | Recruiting

• 2 other identifiers: 2024-3-1574-10322024/3-1574-1032
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

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.

Conditions

Septic Cardiomyopathy

Keywords

Septic cardiomyopathy; Sepsis; Septic shock

Outcome Measures

Primary Outcomes (1)

• Incidence of septic cardiomyopathy when comparing a new clinical-echocardiographic model with the standard diagnostic method (left ventricular ejection fraction).

  Incidence of septic cardiomyopathy, evaluated by comparing the diagnostic accuracy of a new clinical-echocardiographic model with the standard method, left ventricular ejection fraction (LVEF) measurement. The study will determine whether the new model improves the diagnosis of septic cardiomyopathy in patients with sepsis or septic shock.

  From enrollment to the end of one-year follow-up.

Secondary Outcomes (5)

• Assessing the severity of septic cardiomyopathy and determining the severity grade.

  From enrollment to the end of one-year follow-up.

• Length of intensive care unit and hospital stay

  Intensive care unit days spent per patient: within 60 days following intensive care unit admission. Hospital days spent per patient: from admission up to 30 days.

• Mortality

  Within 1 year of inclusion

• Recovery of cardiac function

  Within 30 days of inclusion

• Long-term health and functional outcomes

  Within 1 year of inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for sepsis or septic shock in the Intensive Care Units of two university hospitals.

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vilnius University: lead
• Vilnius University Hospital Santaros Klinikos: collaborator

Study Sites (2)

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

RECRUITING

University Clinical Centre of the Medical University of Warsaw

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 27, 2025
• Study Start: March 17, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 27, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); LI (1)