Relationship Between Elevated Soluble Cluster of Differentiation 74 (CD74) and Severity of Experimental and Clinical ALI/ARDS.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Acute Physiology and Chronic Health Evaluation (APACHE) II Scores
研究概览
简要总结
Efforts to identify circulating factors that predict severity of acute lung injury/acute respiratory distress syndrome（ALI/ARDS） patients is unrevealing. The primary purpose of this study is to verify our hypothesis that soluble CD74 might be a potential novel ALI/ARDS biomarker.
详细描述
Acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) is a devastating cause of morbidity and mortality characterized by alveolar epithelial and endothelial injury. Despite recent advances in pathogenetic mechanisms and therapy strategies of ALI, efforts to identify circulating factors that predict severity of ALI/ARDS patients have been unrevealing.
CD74 (also known as a major histocompatibility complex (MHC) class II invariant chain) is a type II transmembrane protein, recently found to be the high-affinity receptor of macrophage migration inhibitory factor (MIF). MIF promotes neutrophil accumulation in alveolar space via binding to CD74 expressed on the cell surface. Our previous study， consistent with others, has shown that MIF was highly expressed in acute lung injury (ALI). In addition, we also detected highly CD74 expression in lipopolysaccharide (LPS)-induced ALI mouse model. Recently, a circulating form of CD74 was discovered in autoimmune liver disease. Similarly, we investigated the existence of soluble form of CD74 in serum and bronchoalveolar lavage fluid (BALF) in ALI mouse model and burn or trauma related ALI patients. Based on these finds, we postulated that soluble CD74 might participate in regulating lung inflammation and be a potential novel ALI/ARDS biomarker.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of ALI/ARDS
- •Informed consent was obtained from either the subjects themselves or from designated surrogates before enrollment in the study.
排除标准
- •Patients who have chronic lung disease before enrollment.
- •Patients who have severe organ dysfunction, autoimmune diseases and tumor.
- •Women who are pregnant or breast-feeding.
- •Patients who, in the opinion of the Investigator, have any other medical condition which renders the patient unable to complete the study or which would interfere with optimal participation in the study or produce significant risk to the patient.
- •Patients participating in or planning to enroll in another clinical trial during the time of the study.
结局指标
主要结局
Acute Physiology and Chronic Health Evaluation (APACHE) II Scores
时间窗: up to 28 days
APACHE II scores range from 0 to 71. A higher values represent a worse outcome.
Number of Participants Receiving Mechanical Ventilation
时间窗: up to 28 days
Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)
时间窗: up to 28 days
Serum Soluble Cluster of Differentiations 74 (sCD74)
时间窗: Day 3
The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.
次要结局
- IL-6(Day 3)
- MIF(Day 3)
- Length of Stay in the ICU(1 year)
- TNF-α(Day 3)
- Length of Hospital Stay(1 year)
- Days of Unassisted Ventilation(1 year)
- Death(up to 28 days)