Skip to main content
OpenTrials
Completed

NCT Number: NCT02201446

The Role of Circulating Soluble CD74 in Acute Lung Injury

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Burn and Trauma Sugery, Changhai Hospital

Shanghai, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Participants Receiving Mechanical Ventilation

    Time frame: up to 28 days

  2. Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)

    Time frame: up to 28 days

  3. Acute Physiology and Chronic Health Evaluation (APACHE) II Scores

    Time frame: up to 28 days

    APACHE II scores range from 0 to 71. A higher values represent a worse outcome.

  4. Serum Soluble Cluster of Differentiations 74 (sCD74)

    Time frame: Day 1

    The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.

  5. Serum Soluble Cluster of Differentiations 74 (sCD74)

    Time frame: 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.

Secondary outcomes

  1. Length of Stay in the ICU

    Time frame: 1 year

  2. Length of Hospital Stay

    Time frame: 1 year

  3. Days of Unassisted Ventilation

    Time frame: 1 year

  4. Death

    Time frame: up to 28 days

  5. TNF-α

    Time frame: Day 3

  6. IL-6

    Time frame: Day 3

  7. MIF

    Time frame: Day 3

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Relationship Between Elevated Soluble Cluster of Differentiation 74 (CD74) and Severity of Experimental and Clinical ALI/ARDS.

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jul 28, 2014
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.