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.

University of Turin, Italy200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Septic Shock Immunocompromised Patients

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to 28 days from ICU admission

Secondary Outcomes

clinical severity

Assessment of whether biomarker levels correlate with clinical severity scores in patients with active infection admitted to intensive or step-down care units.

Time frame: Up to 28 days from ICU admission

Organ damage

Evaluation of the correlation between biomarker levels and the degree of organ dysfunction/damage during ICU stay.

Time frame: Up to 28 days from ICU admission

Response to treatment

Assessment of the ability of serial biomarker measurements to reflect and predict response to antimicrobial and supportive treatment.

Time frame: Up to 28 days from ICU admission

Infectious complications

Evaluation of the ability of biomarkers to predict the occurrence of infectious complications, including ventilator-associated pneumonia (VAP) and bacteremia.

Time frame: Up to 28 days from ICU admission

ICU and hospital length of stay

Evaluation of whether biomarker levels at admission and during follow-up correlate with duration of ICU stay and total hospital stay.

Time frame: Up to 180 days from ICU admission

Long-term survival

Evaluation of the correlation between biomarker levels and long-term survival at 90 and 180 days.

Time frame: 90 and 180 days from ICU admission

Early risk stratification in severely immunocompromised patients

Evaluation of the role of biomarkers in early prediction of mortality risk, infectious complications, and superinfections in patients with severe immune deficiency.

Time frame: Up to 28 days from ICU admission

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.

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts