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. (MARINA)
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.
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.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Giorgia Montrucchio, Professor
- Numer telefonu: 00390116331633
- E-mail: giorgiagiuseppina.montrucchio@unito.it
Lokalizacje studiów
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Torino, Włochy, 10126
- Rekrutacyjny
- AOU Città della Salute e della Scienza
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Kontakt:
- Giorgia Montrucchio, Professor
- Numer telefonu: 00390116331633
- E-mail: giorgiagiuseppina.montrucchio@unito.it
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
The study enrolls adult patients (aged ≥18 years) admitted to intensive care units (ICU) or step-down units at participating centers. Three partially overlapping patient populations are included:
- Infection group: patients with suspected or confirmed infection, including sepsis and septic shock, either community- or hospital-acquired.
- Surgical group: patients who have undergone high-risk major surgery under general anesthesia (cardiac, thoracic, or abdominal surgery) within the 24 hours preceding ICU admission, either as elective or emergency procedures.
- Immunocompromised group: patients with severely impaired immune status, including recipients of solid organ transplant (SOT), hematopoietic stem cell transplant (HSCT), bone marrow transplant, or CAR-T cell therapy, as well as patients under any other form of severe immunosuppression, presenting with signs or symptoms of active infection.
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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Septic shock
patients with probable or documented septic shock
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major surgery
patients admitted to ICU after major surgical procedures (cardiac surgery, major abdominal surgery, major thoracic surgery)
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immunocompromised
patients with >= organ failure due to probable or documented immune alteration (hematologic patients, oncologic patients, autoimmune diseases)
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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28-day all-cause mortalityTime Frame: 28 days from ICU admission
Ramy czasowe: Up to 28 days from ICU admission
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To evaluate whether serial measurements of prognostic biomarkers (including procalcitonin, MR-proadrenomedullin, copeptin, ferritin, interleukin-6, lymphocyte subpopulations, and immunoglobulins) can predict 28-day mortality in critically ill patients with active infection, including those undergoing major surgery or with impaired immune status.
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Up to 28 days from ICU admission
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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clinical severity
Ramy czasowe: Up to 28 days from ICU admission
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Assessment of whether biomarker levels correlate with clinical severity scores in patients with active infection admitted to intensive or step-down care units.
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Up to 28 days from ICU admission
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Organ damage
Ramy czasowe: Up to 28 days from ICU admission
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Evaluation of the correlation between biomarker levels and the degree of organ dysfunction/damage during ICU stay.
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Up to 28 days from ICU admission
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Response to treatment
Ramy czasowe: Up to 28 days from ICU admission
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Assessment of the ability of serial biomarker measurements to reflect and predict response to antimicrobial and supportive treatment.
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Up to 28 days from ICU admission
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Infectious complications
Ramy czasowe: Up to 28 days from ICU admission
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Evaluation of the ability of biomarkers to predict the occurrence of infectious complications, including ventilator-associated pneumonia (VAP) and bacteremia.
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Up to 28 days from ICU admission
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ICU and hospital length of stay
Ramy czasowe: Up to 180 days from ICU admission
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Evaluation of whether biomarker levels at admission and during follow-up correlate with duration of ICU stay and total hospital stay.
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Up to 180 days from ICU admission
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Long-term survival
Ramy czasowe: 90 and 180 days from ICU admission
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Evaluation of the correlation between biomarker levels and long-term survival at 90 and 180 days.
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90 and 180 days from ICU admission
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Early risk stratification in severely immunocompromised patients
Ramy czasowe: Up to 28 days from ICU admission
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Evaluation of the role of biomarkers in early prediction of mortality risk, infectious complications, and superinfections in patients with severe immune deficiency.
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Up to 28 days from ICU admission
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ID 887.433 (00458/2023)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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