Acute Respiratory Distress Syndrome, ARDSNCT02944279
Neutrophil Elastase and Elafin as Prognostic Biomarker for Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome, ARDS, run by Peking University Third Hospital.
Trial summary
The acute respiratory distress syndrome (ARDS), characterized by alveolar flooding with protein-rich pulmonary edema fluid, is one of the most common disease in the intensive care unit (ICU) throughout the world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, ARDS
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Aug 2014
- 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: Study population is from five clinical and surgical ICUs in Beijing metropolitan area: Peking University Third Hospital in the northwest of Beijing, Beijing Friendship Hospital in the south, Beijing Shijitan Hospital in the middle, Beijing Xiyuan Hospital in the west, and China-Japan Friendship Hospital in the northeast.
Who may be able to join
None listed.
Who cannot join
- Age <18 years
- History of chronic lung diseases, such as interstitial pulmonary fibrosis or bronchiolitis
- history of pneumonectomy
- Treatment with immunomodulating therapy other than corticosteroids, such as granulocyte colony stimulating factor, cyclophosphamide, cyclosporine, interferon, or TNF-α antagonists
- Presence of other immunodeficient conditions, such as HIV infection, leukemia, or neutropenia (absolute neutrophil count <1000/μl)
- History of organs or bone marrow transplant other than autologous bone marrow transplant
Show all 9Show fewer
- Directive to withhold intubation
- ICU stay duration<72h
- Patient developed ARDS before ICU admission. Sepsis and septic shock were defined according to the Berlin definition
About this study
The acute respiratory distress syndrome (ARDS), characterized by alveolar flooding with protein-rich pulmonary edema fluid, is one of the most common disease in the intensive care unit (ICU) throughout the world. In recent years, much effort has been focused on the biological markers for their potential values to diagnose ARDS and outcomes.
ARDS is generally accompanied by the disruption in alveolar-capillary barrier permeability, which subsequently caused an influx of neutrophils into the interstitium and alveolar space. It was reported that the aggregation, adhesion activation and release proteases of neutrophils are the key pathogenesis of ARDS pulmonary edema. Neutrophil Elastase (HNE), the most crucial protease generated in neutrophil azurophilic granules, plays an important role in various inflammations, especially the lung injury. The destructive action of HNE on almost all extracellular matrix influences cell signaling through cleavage of surface receptors. Once released in circulation, HNE is rapidly inactivated by conjugation with PI3. This local inhibitor reduces HNE mediated tissue injury and inflammation. Thus, the investigators plan to conduct a cohort study with repeated measures to examine the diagnostic and prognostic value of HNE and PI3 for ARDS.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Peking University Third Hospital | Not described | |
| Beijing Friendship Hospital | Not described | |
| Beijing Shijitan Hospital | Not described | |
| Beijing Xiyuan Hospital | Not described | |
| China-Japan Friendship Hospital | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARDS development-Berlin definition
Measured: 60 days
ARDS survival
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startJan 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome, ARDSStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital, Beijing Shijitan Hospital, Capital Medical University, Beijing Xiyuan Hospital, China-Japan Friendship Hospital
- Responsible party
- Principal investigator, Xi Zhu, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944279
- Sponsor's protocol ID
- 2009-1014
- Status last verified
- Oct 2016
- First submitted
- 21 Oct 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil Elastase and Elafin as Prognostic Biomarker for Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02944279
- Acronym / sponsor ID
- 2009-1014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Friendship Hospital, Beijing Shijitan Hospital, Capital Medical University, Beijing Xiyuan Hospital, China-Japan Friendship Hospital
- Study start
- Jan 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Oct 2016 (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 acute respiratory distress syndrome (ARDS), characterized by alveolar flooding with protein-rich pulmonary edema fluid, is one of the most common disease in the intensive care unit (ICU) throughout the world. In recent years, much effort has been focused on the biological markers for their potential values to diagnose ARDS and outcomes.
ARDS is generally accompanied by the disruption in alveolar-capillary barrier permeability, which subsequently caused an influx of neutrophils into the interstitium and alveolar space. It was reported that the aggregation, adhesion activation and release proteases of neutrophils are the key pathogenesis of ARDS pulmonary edema. Neutrophil Elastase (HNE), the most crucial protease generated in neutrophil azurophilic granules, plays an important role in various inflammations, especially the lung injury. The destructive action of HNE on almost all extracellular matrix influences cell signaling through cleavage of surface receptors. Once released in circulation, HNE is rapidly inactivated by conjugation with PI3. This local inhibitor reduces HNE mediated tissue injury and inflammation. Thus, the investigators plan to conduct a cohort study with repeated measures to examine the diagnostic and prognostic value of HNE and PI3 for ARDS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Peking University Third Hospital | – | – |
| Beijing Friendship Hospital | – | – |
| Beijing Shijitan Hospital | – | – |
| Beijing Xiyuan Hospital | – | – |
| China-Japan Friendship Hospital | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is from five clinical and surgical ICUs in Beijing metropolitan area: Peking University Third Hospital in the northwest of Beijing, Beijing Friendship Hospital in the south, Beijing Shijitan Hospital in the middle, Beijing Xiyuan Hospital in the west, and China-Japan Friendship Hospital in the northeast.
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Age <18 years
- History of chronic lung diseases, such as interstitial pulmonary fibrosis or bronchiolitis
- history of pneumonectomy
- Treatment with immunomodulating therapy other than corticosteroids, such as granulocyte colony stimulating factor, cyclophosphamide, cyclosporine, interferon, or TNF-α antagonists
- Presence of other immunodeficient conditions, such as HIV infection, leukemia, or neutropenia (absolute neutrophil count <1000/μl)
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
ARDS development-Berlin definition
Time frame: 60 days
ARDS survival
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, ARDS, run by Peking University Third Hospital.
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 0 inclusion and 9 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 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ARDS development-Berlin definition (time frame: 60 days). 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?
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 25 Oct 2016.