The Role of Circulating Soluble CD74 in Acute Lung Injury

NCT02201446 | Completed Results

• 1 other identifier: 20131224
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lung Injury; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (7)

• Length of Stay in the ICU

  1 year

• Length of Hospital Stay

  1 year

• Days of Unassisted Ventilation

  1 year

• Death

  up to 28 days

• TNF-α

  Day 3

Study Arms (2)

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.

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Department of Burn and Trauma Sugery, Changhai Hospital

Shanghai, 200433, China

Location

Related Publications (1)

• 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.

  PMID: 27444250 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

ARDS patients and healthy volunteers

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Results Point of Contact

• Title: Guo-sheng Wu
• Organization: Department of Burn Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, People's Republic of China

drwuguosheng@sina.cn

+86 18019359841

Study Officials

• Zhaofan Xia, MD PhD

  Department of Burn Sugery, Changhai Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 28, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: April 1, 2015
• Last Updated: February 17, 2017
• Results First Posted: December 15, 2016

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)