NCT07682766 BioMArkeRs of INflammation, Infection, and Immunity in the Critical Area (MARINA): 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.
| NCT ID | NCT07682766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Turin, Italy |
| Condition | Septic Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The MARINA study (bioMARkers of INflammation, infection, and immunity in critical cAre) is a multicenter, prospective and retrospective observational cohort study designed to evaluate the diagnostic and prognostic role of inflammatory and immune biomarkers in critically ill patients. The study enrolls adult patients (≥18 years) admitted to intensive care or step-down units who present with signs or symptoms of active infection, including sepsis and septic shock. Three main patient populations are targeted: (1) patients with suspected or confirmed infection (community- or hospital-acquired); (2) patients undergoing high-risk major surgery (cardiac, thoracic, or abdominal) under general anesthesia; and (3) immunocompromised patients (solid organ transplant, HSCT, bone marrow transplant, CAR-T cell therapy, or other severe immunosuppression). Serial measurements of established and emerging biomarkers - including procalcitonin, C-reactive protein, MR-proadrenomedullina, copeptin, ferritin, interleukin-6, troponin, D-dimer, lactate, lymphocyte subpopulations, and immunoglobulins - are collected at predefined time points (T1: within 24 hours; T2: within 72 hours; T7: at day 7 of ICU admission) and integrated with clinical data on a dedicated electronic platform. The primary endpoint is 28-day mortality. Secondary endpoints include assessment of organ damage, clinical severity, response to treatment, infectious complications (including VAP and bacteremia), superinfections (bacterial, viral, fungal), ICU and hospital length of stay, and the ability of biomarkers to guide antimicrobial de-escalation. Long-term survival at 90 and 180 days is also assessed. A minimum sample size of 200 patients (prospective phase) is planned across participating centers in Italy and Spain. The study duration is four years from ethical approval.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07682766 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07682766 currently recruiting?
Yes, NCT07682766 is actively recruiting participants. Contact the research team at giorgiagiuseppina.montrucchio@unito.it for enrollment information.
Where is the NCT07682766 trial being conducted?
This trial is being conducted at Torino, Italy.
Who is sponsoring the NCT07682766 clinical trial?
NCT07682766 is sponsored by University of Turin, Italy. The trial plans to enroll 200 participants.