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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)

26. juni 2026 opdateret af: University of Turin, Italy

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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

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Studiekontakt

Studiesteder

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Septic shock
patients with probable or documented septic shock
major surgery
patients admitted to ICU after major surgical procedures (cardiac surgery, major abdominal surgery, major thoracic surgery)
immunocompromised
patients with >= organ failure due to probable or documented immune alteration (hematologic patients, oncologic patients, autoimmune diseases)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
28-day all-cause mortalityTime Frame: 28 days from ICU admission
Tidsramme: Up to 28 days from ICU admission
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.
Up to 28 days from ICU admission

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
clinical severity
Tidsramme: Up to 28 days from ICU admission
Assessment of whether biomarker levels correlate with clinical severity scores in patients with active infection admitted to intensive or step-down care units.
Up to 28 days from ICU admission
Organ damage
Tidsramme: Up to 28 days from ICU admission
Evaluation of the correlation between biomarker levels and the degree of organ dysfunction/damage during ICU stay.
Up to 28 days from ICU admission
Response to treatment
Tidsramme: Up to 28 days from ICU admission
Assessment of the ability of serial biomarker measurements to reflect and predict response to antimicrobial and supportive treatment.
Up to 28 days from ICU admission
Infectious complications
Tidsramme: Up to 28 days from ICU admission
Evaluation of the ability of biomarkers to predict the occurrence of infectious complications, including ventilator-associated pneumonia (VAP) and bacteremia.
Up to 28 days from ICU admission
ICU and hospital length of stay
Tidsramme: Up to 180 days from ICU admission
Evaluation of whether biomarker levels at admission and during follow-up correlate with duration of ICU stay and total hospital stay.
Up to 180 days from ICU admission
Long-term survival
Tidsramme: 90 and 180 days from ICU admission
Evaluation of the correlation between biomarker levels and long-term survival at 90 and 180 days.
90 and 180 days from ICU admission
Early risk stratification in severely immunocompromised patients
Tidsramme: Up to 28 days from ICU admission
Evaluation of the role of biomarkers in early prediction of mortality risk, infectious complications, and superinfections in patients with severe immune deficiency.
Up to 28 days from ICU admission

Samarbejdspartnere og efterforskere

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Sponsor

University of Turin, Italy

Datoer for undersøgelser

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Studer store datoer

Studiestart (Faktiske)

1. januar 2025

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ID 887.433 (00458/2023)

Plan for individuelle deltagerdata (IPD)

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