Sepsis and Hospital Mortality
ConditionSepsis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Calabria
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Cardiology patients without documented infection (Control Group)
Patients with sepsis
Patients with nosocomial infection
Disqualifiers
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)
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
conductivity and dieletric constant
Diagnostic testcollecting blood samples and directly measuring plasma conductivity and dielectric constant using microwave probes already validated for non-invasive glucose monitoring.
Treatment groups
100 Participants
are divided into 5 treatment groupsGroup A: Sepsis1 intervention
Group B: Myocarditis1 intervention
Group C: Pericarditis1 intervention
Group D: Endocarditis1 intervention
Group E: Control Cases1 intervention
Trial outcomes
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.
Time frame
through study completion, an average of 10 daysSecondary outcomes
1
Correlation Between Biophysical Parameters and Conventional Infection and Inflammation Biomarkers
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.
Time frame
through study completion, an average of 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov