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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 28-day all-cause mortalityTime Frame: 28 days from ICU admission
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
28-day all-cause mortalityTime Frame: 28 days from ICU admission
时间窗: 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.
次要结局
- 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)
- Long-term survival(90 and 180 days from ICU admission)
- Early risk stratification in severely immunocompromised patients(Up to 28 days from ICU admission)