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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARDS patients | Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent. | ||
| Healthy volunteers | Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Receiving Mechanical Ventilation | up to 28 days | |
| Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2) | up to 28 days | |
| Acute Physiology and Chronic Health Evaluation (APACHE) II Scores | APACHE II scores range from 0 to 71. A higher values represent a worse outcome. | up to 28 days |
| Serum Soluble Cluster of Differentiations 74 (sCD74) | The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein. | Day 1 |
| Serum Soluble Cluster of Differentiations 74 (sCD74) | The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein. | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay in the ICU | 1 year | |
| Length of Hospital Stay | 1 year | |
| Days of Unassisted Ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with and without ARDS were screened from Changhai Hospital. Patients were enrolled consecutively over a 2-year time period (2014-2015). All enrolled patients with ALI met the American-European Consensus Committee criteria.In addition, healthy individuals were recruited from the general population.
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| Name | Affiliation | Role |
|---|---|---|
| Zhaofan Xia, MD PhD | Department of Burn Sugery, Changhai Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Burn and Trauma Sugery, Changhai Hospital | Shanghai | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27444250 | Result | Wu G, Sun Y, Wang K, Chen Z, Wang X, Chang F, Li T, Feng P, Xia Z. Relationship between elevated soluble CD74 and severity of experimental and clinical ALI/ARDS. Sci Rep. 2016 Jul 22;6:30067. doi: 10.1038/srep30067. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ARDS Patients | Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent. |
| FG001 | Healthy Volunteers | Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ARDS Patients | Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The age of participant. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Receiving Mechanical Ventilation | not collected for healthy volunteers | Posted | Number | participants | up to 28 days |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARDS Patients | Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart failure | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Astriction or diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guo-sheng Wu | Department of Burn Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, People's Republic of China | +86 18019359841 | drwuguosheng@sina.cn |
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| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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ARDS patients and healthy volunteers
| 1 year |
| Death | up to 28 days |
| TNF-α | Day 3 |
| IL-6 | Day 3 |
| MIF | Day 3 |
| BG001 | Healthy Volunteers | Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Gender | Count of Participants | Participants |
|
| Sequential Organ Failure Assessment(SOFA) | SOFA score ranges from 0 to 43. A higher values represent a worse outcome. | Mean | Standard Deviation | Scores on a scale |
|
| Trauma | Number | participants |
|
| Inhalation injury | Number | participants |
|
| Diabetes mellitus | Number | participants |
|
| Hypertension | Number | participants |
|
| Kidney disease | Number | participants |
|
| Respiratory disease | Number | participants |
|
| Blood diseases | Number | participants |
|
| Day1 tumor necrosis factor-α(TNF-α) | Mean | Inter-Quartile Range | pg/ml |
|
| Day1 interleukin-6 (IL-6) | Mean | Inter-Quartile Range | pg/ml |
|
| Day1 migration inhibitory factor (MIF) | Mean | Standard Deviation | ng/ml |
|
|
|
| Primary | Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2) | not collected for healthy volunteers | Posted | Mean | Standard Deviation | ratio | up to 28 days |
|
|
|
| Primary | Acute Physiology and Chronic Health Evaluation (APACHE) II Scores | APACHE II scores range from 0 to 71. A higher values represent a worse outcome. | not collected for healthy volunteers | Posted | Mean | Standard Deviation | Scores on a scale | up to 28 days |
|
|
|
| Primary | Serum Soluble Cluster of Differentiations 74 (sCD74) | The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein. | Posted | Mean | Standard Deviation | ng/ml | Day 1 |
|
|
|
| Primary | Serum Soluble Cluster of Differentiations 74 (sCD74) | The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein. | Only 62 ARDS patients with Day 3 blood samples were analyzed. | Posted | Mean | Standard Deviation | ng/ml | Day 3 |
|
|
|
| Secondary | Length of Stay in the ICU | not collected for healthy volunteers | Posted | Mean | Inter-Quartile Range | days | 1 year |
|
|
|
| Secondary | Length of Hospital Stay | Posted | Mean | Inter-Quartile Range | days | 1 year |
|
|
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| Secondary | Days of Unassisted Ventilation | Posted | Mean | Inter-Quartile Range | days | 1 year |
|
|
|
| Secondary | Death | Posted | Number | participants | up to 28 days |
|
|
|
| Secondary | TNF-α | Only 62 ARDS patients with Day 3 blood samples were analyzed | Posted | Mean | Standard Deviation | pg/ml | Day 3 |
|
|
|
| Secondary | IL-6 | Only 62 ARDS patients with Day 3 blood samples were analyzed | Posted | Mean | Standard Deviation | pg/ml | Day 3 |
|
|
|
| Secondary | MIF | Only 62 ARDS patients with Day 3 blood samples were analyzed | Posted | Mean | Standard Deviation | ng/ml | Day 3 |
|
|
|
| 14 |
| 81 |
| 0 |
| 81 |
| EG001 | Healthy Volunteers | Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients. | 0 | 58 | 0 | 58 |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Renal inadequacy | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory infection | Infections and infestations | Systematic Assessment |
|
| Death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Anxiety or depression | Nervous system disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
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