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NCT Number: NCT07022041

Sepsis and Hospital Mortality

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

''Annunziata'' Hospital

Cosenza, 87100, Italy

Location status: Recruiting

Location contact

Antonio Curcio, Medicine

CONTACT

[email protected]

+390984681877

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Comparative Analysis of Plasma Bioelectrical Properties in Sepsis

    Time frame: through study completion, an average of 10 days

    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.

Secondary outcomes

  1. Correlation Between Biophysical Parameters and Conventional Infection and Inflammation Biomarkers

    Time frame: through study completion, an average of 3 months

    correlations will be assessed between measured biophysical parameters and conventional infection/inflammation biomarkers (e.g., ESR, procalcitonin, CRP, and white blood cell count) in patients with suspected or confirmed infection.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Curcio, Medicine

CONTACT

[email protected]

+390984681877

Sponsors and collaborators

Lead sponsor

University of Calabria

Other

Registry information

Official study title

Sepsis Mortality in Hospitals: a Quality Indicator in Acute Care Settings

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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