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.

NCT07682766 | Recruiting

• 1 other identifier: ID 887.433 (00458/2023)
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Immunocompromised Patients

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortalityTime Frame: 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

Secondary Outcomes (7)

• clinical severity

  Up to 28 days from ICU admission

• Organ damage

  Up to 28 days from ICU admission

• Response to treatment

  Up to 28 days from ICU admission

• Infectious complications

  Up to 28 days from ICU admission

• ICU and hospital length of stay

  Up to 180 days from ICU admission

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

AOU Città della Salute e della Scienza

Torino, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Giorgia Montrucchio, Professor

CONTACT

00390116331633; giorgiagiuseppina.montrucchio@unito.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)