Biomarkers of Inflammation, Infection, and Immunity in Critically Ill Patients
Official title: The MARINA Study: bioMArkeRs of INflammation, Infection, and Immunity in the Critical Area: the Use of Inflammatory and Immunity Biomarkers as Early Predictors of Clinical Severity, Organ Damage, Response to Treatment, and Infectious Complications in Patients Admitted to the Critical Care Area.
Run by University of Turin, Italy · NCT07682766 · Data updated 2026-11-12
This study tests whether blood biomarkers can predict illness severity and complications in adults admitted to intensive care with infection, including sepsis, and in immunocompromised or high-risk surgical patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Turin, Italy Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Torino) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07682766 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18 years and older) admitted to ICU or step-down units with suspected or confirmed infection, high-risk surgical patients within 24 hours post-procedure, or immunocompromised individuals.
✕Probably not a fit
Patients without infection, without high-risk surgery, or without immunocompromised status may have limited relevance to the study goals.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
MARINA is an observational study that collects biomarker data from adults in critical care to see how inflammatory and immune markers relate to disease severity, organ damage, treatment response, and infectious complications. It includes patients with suspected or confirmed infections, those undergoing high-risk major surgery, and immunocompromised individuals. The study uses serial measurements of both established and emerging biomarkers, such as procalcitonin and C-reactive protein, to explore prognostic patterns. Data are gathered from multiple centers, combining prospective and retrospective elements to understand relationships between biomarkers and clinical outcomes. Interventions are not part of the protocol; the study focuses on observational associations to inform future risk assessment.
Why it matters
Potential benefit: If successful, the findings could improve early risk stratification and guide more personalized care for critically ill patients with infection or immunocompromised status.
How similar studies have gone: Previous observational work in critical care has linked biomarker patterns to outcomes, supporting the potential value of MARINA’s approach, though this specific multi-population design is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Written informed consent to participate in the study (or deferred consent, obtained as soon as clinically feasible, in patients unable to provide consent at the time of enrollment) * Surgical group: patients who have undergone a high-risk elective or emergency surgical procedure under general anesthesia within the previous 24 hours (cardiac surgery, thoracic surgery, abdominal surgery) * Infection group: suspected or confirmed infection (including sepsis and septic shock), either community- or hospital-acquired * Immunocompromised group (subset of the infection group): patients with impaired immune status, including solid organ transplant (SOT) recipients, hematopoietic stem cell transplant (HSCT) recipients, bone marrow transplant recipients, CAR-T cell therapy recipients, or any other form of severe immunosuppression Exclusion Criteria: * Refusal to provide informed consent * Age \< 18 years * Pregnancy * Therapeutic limitations or clinical decision to withdraw or withhold life-sustaining treatment at the time of enrollment
Where it's running
-
AOU Città della Salute e della Scienza
Torino, Italy Recruiting
Study contacts
- Study coordinator: Giorgia Montrucchio, Professor
- Email: giorgiagiuseppina.montrucchio@unito.it
- Phone: 00390116331633
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.