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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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Turin, Italy

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2025

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

26. juni 2026

Først innsendt som oppfylte QC-kriteriene

26. juni 2026

Først lagt ut (Faktiske)

6. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ID 887.433 (00458/2023)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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