Trial Outcomes & Findings for The Role of Circulating Soluble CD74 in Acute Lung Injury (NCT NCT02201446)

NCT ID: NCT02201446

Last Updated: 2017-02-17

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 139 participants
• Primary outcome timeframe: up to 28 days
• Results posted on: 2017-02-17

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	81	58
Overall Study COMPLETED	81	58
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Role of Circulating Soluble CD74 in Acute Lung Injury

Baseline characteristics by cohort

Measure	ARDS Patients n=81 Participants 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 n=58 Participants Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.	Total n=139 Participants Total of all reporting groups
Age, Continuous	48.02 years STANDARD_DEVIATION 16.05 • n=5 Participants	39.52 years STANDARD_DEVIATION 10.43 • n=7 Participants	44.47 years STANDARD_DEVIATION 14.58 • n=5 Participants
Gender Female	37 Participants n=5 Participants	26 Participants n=7 Participants	63 Participants n=5 Participants
Gender Male	44 Participants n=5 Participants	32 Participants n=7 Participants	76 Participants n=5 Participants
Sequential Organ Failure Assessment(SOFA)	7.16 Scores on a scale STANDARD_DEVIATION 3.70 • n=5 Participants	NA Scores on a scale STANDARD_DEVIATION NA • n=7 Participants	7.16 Scores on a scale STANDARD_DEVIATION 3.70 • n=5 Participants
Trauma	35 participants n=5 Participants	0 participants n=7 Participants	35 participants n=5 Participants
Inhalation injury	46 participants n=5 Participants	0 participants n=7 Participants	46 participants n=5 Participants
Diabetes mellitus	8 participants n=5 Participants	0 participants n=7 Participants	8 participants n=5 Participants
Hypertension	15 participants n=5 Participants	0 participants n=7 Participants	15 participants n=5 Participants
Kidney disease	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Respiratory disease	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Blood diseases	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Day1 tumor necrosis factor-α(TNF-α)	97.09 pg/ml n=5 Participants	NA pg/ml n=7 Participants	97.09 pg/ml n=5 Participants
Day1 interleukin-6 (IL-6)	101.63 pg/ml n=5 Participants	NA pg/ml n=7 Participants	101.63 pg/ml n=5 Participants
Day1 migration inhibitory factor (MIF)	73.64 ng/ml STANDARD_DEVIATION 23.27 • n=5 Participants	NA ng/ml STANDARD_DEVIATION NA • n=7 Participants	73.64 ng/ml STANDARD_DEVIATION 23.27 • n=5 Participants

PRIMARY outcome

Timeframe: up to 28 days

Population: not collected for healthy volunteers

Outcome measures

Measure	ARDS Patients n=81 Participants 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 n=58 Participants Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
Number of Participants Receiving Mechanical Ventilation	51 participants	NA participants not collected for healthy volunteers

PRIMARY outcome

Timeframe: up to 28 days

Population: not collected for healthy volunteers

Outcome measures

Measure	ARDS Patients n=81 Participants 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 n=58 Participants Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)	2.1 ratio Standard Deviation 0.46	NA ratio Standard Deviation NA not collected for healthy volunteers

PRIMARY outcome

Timeframe: up to 28 days

Population: not collected for healthy volunteers

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

Outcome measures

Measure	ARDS Patients n=81 Participants 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 n=58 Participants Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
Acute Physiology and Chronic Health Evaluation (APACHE) II Scores	14.35 Scores on a scale Standard Deviation 6.39	NA Scores on a scale Standard Deviation NA not collected for healthy volunteers

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	ARDS Patients n=81 Participants 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 n=58 Participants Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
Serum Soluble Cluster of Differentiations 74 (sCD74)	87.04 ng/ml Standard Deviation 31.53	-14.77 ng/ml Standard Deviation 15.57

PRIMARY outcome

Timeframe: Day 3

Population: Only 62 ARDS patients with Day 3 blood samples were analyzed.

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

Outcome measures

Measure	ARDS Patients n=62 Participants 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 n=58 Participants Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
Serum Soluble Cluster of Differentiations 74 (sCD74)	132.92 ng/ml Standard Deviation 40.40	-14.78 ng/ml Standard Deviation 15.57

SECONDARY outcome

Timeframe: 1 year

Population: not collected for healthy volunteers

Outcome measures

Measure	ARDS Patients n=81 Participants 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 n=58 Participants Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
Length of Stay in the ICU	23 days Interval 15.0 to 44.0	NA days not collected for healthy volunteers

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	ARDS Patients n=81 Participants 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 n=58 Participants Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
Length of Hospital Stay	36.94 days Interval 22.0 to 53.0	NA days not collected for healthy volunteers

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	ARDS Patients n=81 Participants 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 n=58 Participants Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
Days of Unassisted Ventilation	22 days Interval 8.5 to 28.0	NA days not collected for healthy volunteers

SECONDARY outcome

Timeframe: up to 28 days

Outcome measures

Measure	ARDS Patients n=81 Participants 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 n=58 Participants Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
Death	14 participants	0 participants

SECONDARY outcome

Timeframe: Day 3

Population: Only 62 ARDS patients with Day 3 blood samples were analyzed

Outcome measures

Measure	ARDS Patients n=62 Participants 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 n=58 Participants Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
TNF-α	138.67 pg/ml Standard Deviation 64.26	NA pg/ml Standard Deviation NA not collected for healthy volunteers

SECONDARY outcome

Timeframe: Day 3

Population: Only 62 ARDS patients with Day 3 blood samples were analyzed

Outcome measures

Measure	ARDS Patients n=62 Participants 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 n=58 Participants Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
IL-6	305.36 pg/ml Standard Deviation 177.14	NA pg/ml Standard Deviation NA not collected for healthy volunteers

SECONDARY outcome

Timeframe: Day 3

Population: Only 62 ARDS patients with Day 3 blood samples were analyzed

Outcome measures

Measure	ARDS Patients n=62 Participants 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 n=58 Participants Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
MIF	129.27 ng/ml Standard Deviation 41.12	NA ng/ml Standard Deviation NA not collected for healthy volunteers

Adverse Events

ARDS Patients

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	ARDS Patients n=81 participants at risk 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 n=58 participants at risk Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
Cardiac disorders Heart failure	0.00% 0/81 • 1 month	0.00% 0/58 • 1 month
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/81 • 1 month	0.00% 0/58 • 1 month
Renal and urinary disorders Renal inadequacy	0.00% 0/81 • 1 month	0.00% 0/58 • 1 month
Infections and infestations Respiratory infection	0.00% 0/81 • 1 month	0.00% 0/58 • 1 month
Respiratory, thoracic and mediastinal disorders Death	17.3% 14/81 • Number of events 14 • 1 month	0.00% 0/58 • 1 month

Other adverse events

Measure	ARDS Patients n=81 participants at risk 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 n=58 participants at risk Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
Gastrointestinal disorders Astriction or diarrhea	0.00% 0/81 • 1 month	0.00% 0/58 • 1 month
Nervous system disorders Anxiety or depression	0.00% 0/81 • 1 month	0.00% 0/58 • 1 month
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/81 • 1 month	0.00% 0/58 • 1 month
General disorders Fever	0.00% 0/81 • 1 month	0.00% 0/58 • 1 month

Additional Information

Guo-sheng Wu

Department of Burn Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, People's Republic of China

Phone: +86 18019359841

Email: drwuguosheng@sina.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place