Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

200

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

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)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
28-day all-cause mortalityTime Frame: 28 days from ICU admission
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
clinical severity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Turin, Italy

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Januar 2025

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

31. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

26. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Juni 2026

Zuerst gepostet (Tatsächlich)

6. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ID 887.433 (00458/2023)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren