SepsisNCT07022041
Sepsis and Hospital Mortality
An observational study of Sepsis, run by University of Calabria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- conductivity and dieletric constant
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2025to 15 Dec 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
''Annunziata'' Hospital
Cosenza, 87100
Antonio Curcio, Medicine, +390984681877, antonio.curcio.cardio@unical.it
About this study
Official title: Sepsis Mortality in Hospitals: a Quality Indicator in Acute Care Settings
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
- Being tested
- conductivity and dieletric constant
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conductivity and dieletric constantDiagnostic test
collecting blood samples and directly measuring plasma conductivity and dielectric constant using microwave probes already validated for non-invasive glucose monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Not described Receives: Diagnostic Test: conductivity and dieletric constant | |
| Myocarditis | Not described Receives: Diagnostic Test: conductivity and dieletric constant | |
| Pericarditis | Not described Receives: Diagnostic Test: conductivity and dieletric constant | |
| Endocarditis | Not described Receives: Diagnostic Test: conductivity and dieletric constant | |
| Control Cases | Not described Receives: Diagnostic Test: conductivity and dieletric constant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 10 days
Secondary 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.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start15 Jul 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- University of Calabria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Curcio, University of Calabria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022041
- Sponsor's protocol ID
- 59/2025
- Status last verified
- Aug 2025
- First submitted
- 6 Jun 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis Mortality in Hospitals: a Quality Indicator in Acute Care Settings
- ClinicalTrials.gov ID
- NCT07022041
- Acronym / sponsor ID
- 59/2025
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalabriaUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Cardiology patients without documented infection (Control Group)
- Patients with sepsis
- Patients with nosocomial infection
- Patients with myocarditis, endocarditis, or pericarditis
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conductivity and dieletric constantcollecting blood samples and directly measuring plasma conductivity and dielectric constant using microwave probes already validated for non-invasive glucose monitoring. | Diagnostic test | Control Cases, Endocarditis, Myocarditis, Pericarditis, Sepsis |
Primary outcome
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.
1 secondary outcome
Correlation Between Biophysical Parameters and Conventional Infection and Inflammation Biomarkers
Time frame: through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by University of Calabria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Curcio, Medicine (+390984681877, antonio.curcio.cardio@unical.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative Analysis of Plasma Bioelectrical Properties in Sepsis (time frame: through study completion, an average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.