Sepsis and Hospital Mortality

NCT07022041 | Recruiting

• 1 other identifier: 59/2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is one of the leading causes of hospital mortality, with a rate of approximately 20% (World Health Organization) among vulnerable patients admitted to high-intensity care units such as CCUs and inpatient wards. Currently, diagnostic criteria such as the Systemic Inflammatory Response Syndrome (SIRS) and the Sequential Organ Failure Assessment (SOFA) score, although widely used, lack sufficient specificity and accuracy. No established parameters are available for early and timely diagnosis. This study aims to address this gap by investigating the variability of blood plasma conductivity and dielectric constant using microwave probes previously validated for non-invasive glucose monitoring. The acquired data will be analyzed using the Anritsu VectorStar VNA to identify innovative and reliable parameters associated with the presence of severe infections.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Comparative Analysis of Plasma Bioelectrical Properties in Sepsis

  differences in blood plasma conductivity and dielectric constant will be analyzed between patients with and without sepsis, using validated microwave probes and appropriate statistical methods.

  through study completion, an average of 10 days

Secondary Outcomes (1)

• Correlation Between Biophysical Parameters and Conventional Infection and Inflammation Biomarkers

  through study completion, an average of 3 months

Study Arms (5)

Sepsis

Diagnostic Test: conductivity and dieletric constant

Myocarditis

Diagnostic Test: conductivity and dieletric constant

Pericarditis

Diagnostic Test: conductivity and dieletric constant

Endocarditis

Diagnostic Test: conductivity and dieletric constant

Control Cases

Diagnostic Test: conductivity and dieletric constant

Interventions

conductivity and dieletric constant DIAGNOSTIC_TEST

collecting blood samples and directly measuring plasma conductivity and dielectric constant using microwave probes already validated for non-invasive glucose monitoring.

Control Cases; Endocarditis; Myocarditis; Pericarditis; Sepsis

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

Adult cardiac patients aged 18 years and older, both with and without infections, are considered, while those with severe comorbidities or undergoing treatments that may influence the study outcomes are excluded.

You may qualify if:

• Age ≥ 18 years
• Cardiology patients without documented infection (Control Group)
• Patients with sepsis
• Patients with nosocomial infection
• Patients with myocarditis, endocarditis, or pericarditis
• Ability to provide written informed consent

You may not qualify if:

• Patients with severe or chronic medical conditions that may interfere with study results, such as autoimmune diseases, renal or hepatic failure
• Patients taking medications that could affect the measured biophysical parameters, such as corticosteroids or immunosuppressants
• Patients with cancer
• Patients with diseases involving the immune system (e.g., lymphomas, leukemias)
• Patients with congenital or acquired immunodeficiencies (e.g., HIV)
• Patients who are unable to read and sign the informed consent form

Sponsors & Collaborators

• University of Calabria: lead

Study Sites (1)

''Annunziata'' Hospital

Cosenza, 87100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Sepsis

Interventions

Electric Conductivity

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electricity; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena

Central Study Contacts

Antonio Curcio, Medicine

CONTACT

+390984681877; antonio.curcio.cardio@unical.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)