Acute Lung InjuryNCT02201446
The Role of Circulating Soluble CD74 in Acute Lung Injury
An observational study of Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Lung Injury, Acute Respiratory Distress Syndrome
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Apr 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Clinical diagnosis of ALI/ARDS
- Informed consent was obtained from either the subjects themselves or from designated surrogates before enrollment in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Burn and Trauma Sugery, Changhai Hospital
Shanghai, 200433
About this study
Official title: Relationship Between Elevated Soluble Cluster of Differentiation 74 (CD74) and Severity of Experimental and Clinical ALI/ARDS.
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.
Read the 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.
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Receiving Mechanical Ventilation
Measured: up to 28 days
Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 3
Secondary outcomes (7)
Length of Stay in the ICU
Measured: 1 year
Length of Hospital Stay
Measured: 1 year
Days of Unassisted Ventilation
Measured: 1 year
Death
Measured: up to 28 days
TNF-α
Measured: Day 3
IL-6
Measured: Day 3
MIF
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaofan Xia, Changhai Hospital
- Investigators
- Zhaofan Xia, MD PhD, Study director, Department of Burn Sugery, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201446
- Sponsor's protocol ID
- 20131224
- Status last verified
- Jan 2017
- First submitted
- 24 Jul 2014
- Last updated
- 17 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27444250
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Elevated Soluble Cluster of Differentiation 74 (CD74) and Severity of Experimental and Clinical ALI/ARDS.
- ClinicalTrials.gov ID
- NCT02201446
- Acronym / sponsor ID
- 20131224
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Posted 15 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Clinical diagnosis of ALI/ARDS
- Informed consent was obtained from either the subjects themselves or from designated surrogates before enrollment in the study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Receiving Mechanical Ventilation
Time frame: up to 28 days
Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)
Time frame: up to 28 days
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.
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.
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.
7 secondary outcomes
Length of Stay in the ICU
Time frame: 1 year
Length of Hospital Stay
Time frame: 1 year
Days of Unassisted Ventilation
Time frame: 1 year
Death
Time frame: up to 28 days
TNF-α
Time frame: Day 3
IL-6
Time frame: Day 3
MIF
Time frame: Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27444250Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaofan Xia, MD PhD study director
Department of Burn Sugery, Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Receiving Mechanical Ventilation (time frame: up to 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02201446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.