The Role of Circulating Soluble CD74 in Acute Lung Injury

NCT ID: NCT02201446

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 139 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

Acute Lung Injury; Acute Respiratory Distress Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of ALI/ARDS
• Informed consent was obtained from either the subjects themselves or from designated surrogates before enrollment in the study.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhaofan Xia

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhaofan Xia, MD PhD

Role: STUDY_DIRECTOR

Department of Burn Sugery, Changhai Hospital

Locations

Department of Burn and Trauma Sugery, Changhai Hospital

Shanghai, , China

Countries

China

References

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.

Reference Type: RESULT

PMID: 27444250 (View on PubMed)

Other Identifiers

20131224

Identifier Type: -

Identifier Source: org_study_id