Immunocompromised Patients, Septic Shock
Conditions
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.
Interventions
None listed
Sponsors
University of Turin, Italy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day all-cause mortalityTime Frame: 28 days from ICU admission | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical severity | 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. |
| Organ damage | Up to 28 days from ICU admission | Evaluation of the correlation between biomarker levels and the degree of organ dysfunction/damage during ICU stay. |
| Response to treatment | 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. |
| Infectious complications | 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. |
| ICU and hospital length of stay | 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. |
| Long-term survival | 90 and 180 days from ICU admission | Evaluation of the correlation between biomarker levels and long-term survival at 90 and 180 days. |
| Early risk stratification in severely immunocompromised patients | 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. |
Countries
Italy
Contacts
CONTACTGiorgia Montrucchio, Professor
Outcome results
None listed