Mechanisms of Prognostic Regulation andPrecision Phenotype Ldentification in Severe Infections Driven by SpecializedPro-Resolving Mediators
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
研究概览
简要总结
This is a prospective observational study involving adult patients with severe infection who are admitted to the intensive care unit (ICU). Severe infection and sepsis are major causes of death worldwide. Many patients experience uncontrolled inflammation or immune suppression, but current tests are limited in identifying which patients are at highest risk.
This study focuses on specialized pro-resolving mediators (SPMs), a group of naturally occurring lipid molecules that help the body turn off inflammation and promote healing. Blood samples that are collected during routine clinical care will be used to measure levels of SPMs. No additional blood draws or experimental treatments will be performed.
The purpose of this study is to understand how SPM levels change over time in patients with severe infection and how these changes relate to organ function and outcomes such as survival. By combining SPM measurements with routine laboratory results, immune cell counts, and imaging findings, the study aims to identify different clinical phenotypes and to develop tools that may help doctors recognize high-risk patients earlier in the future.
All participants will receive standard medical care determined by their treating physicians. No experimental drugs or interventions are given as part of this study.
详细描述
Severe infection and sepsis remain leading causes of morbidity and mortality worldwide. Although antimicrobial therapy and organ support have improved, many critically ill patients continue to experience poor outcomes. Increasing evidence indicates that failure to appropriately resolve inflammation plays a key role in organ dysfunction and mortality. Specialized pro-resolving mediators (SPMs) are endogenous lipid mediators that actively terminate inflammation, promote clearance of pathogens and apoptotic cells, and support tissue repair. However, their role in human severe infection has not been systematically investigated in prospective clinical cohorts.
This study is a prospective observational cohort study enrolling adult patients with severe infection admitted to the intensive care unit (ICU). Approximately 300 patients are expected to be included. Peripheral blood samples obtained during routine clinical care on days 1, 3, and 7 after ICU admission will be analyzed. Plasma SPMs, including resolvins, protectins, and maresins, will be quantified using liquid chromatography-tandem mass spectrometry. Routine clinical data, including demographic characteristics, laboratory tests, immune cell subsets, coagulation indicators, severity scores (SOFA and APACHE II), organ support therapies, and 28-day outcomes will be recorded.
The study has four major objectives:
to describe the temporal profiles of SPMs in severe infection
to determine associations between SPM levels and adverse outcomes including 28-day mortality and organ failure
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Admission to the intensive care unit (ICU)
- •Diagnosis of severe infection or sepsis, as determined by the treating physician according to current clinical criteria
- •Ability to obtain blood samples as part of routine clinical care within 24-48 hours after ICU admission
- •Informed consent provided by the patient or legally authorized representative (when applicable)
排除标准
- •Known pregnancy
- •Known immunosuppressive disease (e.g., hematologic malignancy, advanced HIV infection)
- •Use of long-term immunosuppressive therapy or systemic corticosteroids prior to ICU admission
- •Pre-existing end-stage disease with expected survival < 28 days (e.g., end-stage cancer receiving palliative care)
- •Enrollment in interventional clinical trials that may influence immune or inflammatory responses
- •Refusal of informed consent by the patient or legal representative
- •Patients in whom blood sampling or follow-up is not feasible (e.g., expected transfer, withdrawal of life-sustaining treatment within 24 hours)