Acute Respiratory Distress SyndromeARDSNCT02625064
Discovery of New Early Detection Biomarkers of Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The goal of this project is to find a series novel biomarkers by differential proteomic techniques that can improve the early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Blood samples collection before treatment, Blood samples collection after treatment and laboratory biomarker proteomic analysis
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients at High risk for Extra-pulmonary ARDS and pulmonary ARDS; patients who have ARDS
Who may be able to join
- The Berlin definition of acute respiratory distress syndrome
- ATS definition of severe pneumonia
Who cannot join
- age below 18 years
- pregnancy
- Expected survival under 24 hours
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital
Changsha, Hunan
Pinhua Pan, MD，Doctor, +8613574810968, pinhuapan668@126.com
About this study
The goal of this project is to find a series novel biomarkers by differential proteomic techniques that can improve the early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate.
Read the detailed description
Acute respiratory distress syndrome(ARDS) has a very poor prognosis and high mortality. To improve the early diagnosis of ARDS, there is an urgent need for novel biomarkers of ARDS. The goal of this project is to find a series novel biomarkers by differential proteomic techniques that can improve the early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate. Clinical data and blood sample were recorded before treatment and after treatment. Acute Physiology And Chronic Health Evaluation III (APACHE III) scores were calculated at enrolment. Studying blood specimens from different period ARDS patients by proteomic analysis. It can provide information on a complex composition of proteins that are differentially expressed, which could be used for discovering high sensitivity and specificity ARDS biomarker.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Blood samples collection before treatment, Blood samples collection after treatment, laboratory biomarker proteomic analysis
- Keywords
- ARDS, biomarkers, proteomic
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples collection before treatmentOther
Blood samples collection after treatmentOther
laboratory biomarker proteomic analysisOther
| Study group | Role | What they receive |
|---|---|---|
| 1: patient at High risk for ARDSp | Severe pneumonia and（PaO2/FIO2）>300mmHg Receives: Other: Blood samples collection before treatment; Other: Blood samples collection after treatment; Other: laboratory biomarker proteomic analysis | |
| 2: patient at High risk for ARDSexp | Severe sepsis and without ARDS Receives: Other: Blood samples collection before treatment; Other: Blood samples collection after treatment; Other: laboratory biomarker proteomic analysis | |
| 3: mild ARDS | PaO2/FiO2=201～300 mmHg，and PEEP or CPAP≤5 cm Receives: Other: Blood samples collection before treatment; Other: Blood samples collection after treatment; Other: laboratory biomarker proteomic analysis | |
| 4: moderate ARDS | PaO2/FIO2=101～200 mmHg，且PEEP≥5 cm H2O Receives: Other: Blood samples collection before treatment; Other: Blood samples collection after treatment; Other: laboratory biomarker proteomic analysis | |
| 5: severe ARDS | PaO2/FIO2≤100 mmHg，且PEEP≥10 cm H2O Receives: Other: Blood samples collection before treatment; Other: Blood samples collection after treatment; Other: laboratory biomarker proteomic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS
Measured: baseline
Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS
Measured: 1 month
Secondary outcomes (3)
APACHE III score
Measured: baseline, 1week, 2 weeks
PaO2/FiO2 ratio
Measured: baseline, day 3, day 5, 1week, 2 weeks
Mortality or multi-organ failure
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pinhua Pan, MD, Doctor, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625064
- Sponsor's protocol ID
- 20151030
- Acronym
- ARDS
- Status last verified
- Dec 2015
- First submitted
- 24 Nov 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Janz DR, Ware LB. Biomarkers of ALI/ARDS: pathogenesis, discovery, and relevance to clinical trials. Semin Respir Crit Care Med. 2013 Aug;34(4):537-48. doi: 10.1055/s-0033-1351124. Epub 2013 Aug 11.
PubMed 23934723Ware LB, Calfee CS. Biomarkers of ARDS: what's new? Intensive Care Med. 2016 May;42(5):797-799. doi: 10.1007/s00134-015-3973-0. Epub 2015 Jul 15. No abstract available.
PubMed 26174184Ware LB, Koyama T, Billheimer DD, Wu W, Bernard GR, Thompson BT, Brower RG, Standiford TJ, Martin TR, Matthay MA; NHLBI ARDS Clinical Trials Network. Prognostic and pathogenetic value of combining clinical and biochemical indices in patients with acute lung injury. Chest. 2010 Feb;137(2):288-96. doi: 10.1378/chest.09-1484. Epub 2009 Oct 26.
PubMed 19858233
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery of New Early Detection Biomarkers of Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02625064
- Acronym / sponsor ID
- ARDS / 20151030
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, biomarkers, proteomic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to find a series novel biomarkers by differential proteomic techniques that can improve the early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate.
Detailed description
Acute respiratory distress syndrome(ARDS) has a very poor prognosis and high mortality. To improve the early diagnosis of ARDS, there is an urgent need for novel biomarkers of ARDS. The goal of this project is to find a series novel biomarkers by differential proteomic techniques that can improve the early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate. Clinical data and blood sample were recorded before treatment and after treatment. Acute Physiology And Chronic Health Evaluation III (APACHE III) scores were calculated at enrolment. Studying blood specimens from different period ARDS patients by proteomic analysis. It can provide information on a complex composition of proteins that are differentially expressed, which could be used for discovering high sensitivity and specificity ARDS biomarker.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1: patient at High risk for ARDSp | – | Other: Blood samples collection before treatment, Other: Blood samples collection after treatment, Other: laboratory biomarker proteomic analysisSevere pneumonia and（PaO2/FIO2）>300mmHg |
| 2: patient at High risk for ARDSexp | – | Other: Blood samples collection before treatment, Other: Blood samples collection after treatment, Other: laboratory biomarker proteomic analysisSevere sepsis and without ARDS |
| 3: mild ARDS | – | Other: Blood samples collection before treatment, Other: Blood samples collection after treatment, Other: laboratory biomarker proteomic analysisPaO2/FiO2=201～300 mmHg，and PEEP or CPAP≤5 cm |
| 4: moderate ARDS | – | Other: Blood samples collection before treatment, Other: Blood samples collection after treatment, Other: laboratory biomarker proteomic analysisPaO2/FIO2=101～200 mmHg，且PEEP≥5 cm H2O |
| 5: severe ARDS | – | Other: Blood samples collection before treatment, Other: Blood samples collection after treatment, Other: laboratory biomarker proteomic analysisPaO2/FIO2≤100 mmHg，且PEEP≥10 cm H2O |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients at High risk for Extra-pulmonary ARDS and pulmonary ARDS; patients who have ARDS
Key inclusion criteria (2 listed)
- The Berlin definition of acute respiratory distress syndrome
- ATS definition of severe pneumonia
Key exclusion criteria (3 listed)
- age below 18 years
- pregnancy
- Expected survival under 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples collection before treatment | Other | 1: patient at High risk for ARDSp, 2: patient at High risk for ARDSexp, 3: mild ARDS, 4: moderate ARDS, 5: severe ARDS |
| Blood samples collection after treatment | Other | 1: patient at High risk for ARDSp, 2: patient at High risk for ARDSexp, 3: mild ARDS, 4: moderate ARDS, 5: severe ARDS |
| laboratory biomarker proteomic analysis | Other | 1: patient at High risk for ARDSp, 2: patient at High risk for ARDSexp, 3: mild ARDS, 4: moderate ARDS, 5: severe ARDS |
Primary outcome
Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS
Time frame: baseline
Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS
Time frame: 1 month
3 secondary outcomes
APACHE III score
Time frame: baseline, 1week, 2 weeks
PaO2/FiO2 ratio
Time frame: baseline, day 3, day 5, 1week, 2 weeks
Mortality or multi-organ failure
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Background: PubMed 23934723Janz DR, Ware LB. Biomarkers of ALI/ARDS: pathogenesis, discovery, and relevance to clinical trials. Semin Respir Crit Care Med. 2013 Aug;34(4):537-48. doi: 10.1055/s-0033-1351124. Epub 2013 Aug 11.
- Background: PubMed 26174184Ware LB, Calfee CS. Biomarkers of ARDS: what's new? Intensive Care Med. 2016 May;42(5):797-799. doi: 10.1007/s00134-015-3973-0. Epub 2015 Jul 15. No abstract available.
- Background: PubMed 19858233Ware LB, Koyama T, Billheimer DD, Wu W, Bernard GR, Thompson BT, Brower RG, Standiford TJ, Martin TR, Matthay MA; NHLBI ARDS Clinical Trials Network. Prognostic and pathogenetic value of combining clinical and biochemical indices in patients with acute lung injury. Chest. 2010 Feb;137(2):288-96. doi: 10.1378/chest.09-1484. Epub 2009 Oct 26.
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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.
Pinhua Pan, MD, Doctor principal investigator
Xiangya Hospital of Central South University
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 Respiratory Distress Syndrome, run by Xiangya Hospital of Central South University 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 3 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: status not confirmed, as of the sponsor's last update on 9 Dec 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pinhua Pan, MD, Doctor (+86 13574810968, pinhuapan668@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS (time frame: baseline). The study lists 2 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 NCT02625064, which also lists 3 linked publications.
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 9 Dec 2015.