ARDSNCT03227107
The Evaluation of NETs, Caspase-1 and Cytokines in ARDS Patients
An observational study of ARDS, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
1. enrollment criteria and clinical data collection: follow the principles of medical ethics, the development of inclusion and exclusion criteria, select 90 cases of ARDS patients, in the active treatment at the same time, according to the Berlin standard severity of the disease divided into mild group, moderate Group… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- ARDS
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 30 Dec 2020
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with ARDS
Who may be able to join
- ARDS patients diagnosis within 3 days
- Over 18 years old but no more than 75 years old
Who cannot join
- Severe thoracic open trauma
- Pulmonary embolism
- Severe cardiovascular and cerebrovascular disease
- Endocrine system diseases
- Coagulation dysfunction
- Liver and kidney failure
- Malignant tumors
- Cardiogenic pulmonary edema
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya hospital of Central South University
Changsha, Hunan, 410008
Li Haitao, Doctor, (+86)18684916132, 168101013@csu.edu.cn
About this study
Official title: IRF-1 Regulate Alveolar Macrophage Pyroptosis in Acute Lung Injury and of Which Will be Possible Mechanism
- enrollment criteria and clinical data collection: follow the principles of medical ethics, the development of inclusion and exclusion criteria, select 90 cases of ARDS patients, in the active treatment at the same time, according to the Berlin standard severity of the disease divided into mild group, moderate Group and severe group, according to the prognosis during hospitalization is divided into survival group and death group. BALF specimens were collected on the day of admission to detect the levels of NETs and alveolar macrophages. The acute and chronic health status scoring system Ⅱ (APACHEⅡ) and Murray acute lung injury score, blood routine, creatinine, urea nitrogen, fasting blood glucose, Item, mean arterial pressure, arterial blood gas analysis, oxygenation index; record the patient's mechanical ventilation time and other data;
- Pearson linear correlation analysis of BALF in the content of NETs, alveolar macrophage coke death level was a positive correlation between the Spearman rank correlation analysis BALF in the NETs content and alveolar macrophage coke death level, APACHE Ⅱ, Murray score, creatinine, Urea nitrogen, fasting blood glucose and other indicators and ARDS severity was positively correlated;
- To analyze the prognostic factors of different prognostic factors, to evaluate the content of NETs in BALF, the level of alveolar macrophage coke, APACHEⅡ and Murray scores were analyzed by receiver operator characteristic curve (ROC curve) Short - term survival outcome prognostic value.
- Conditions
- ARDS
What is being measured
The primary outcome is the main question the study is designed to answer.
neutrophil extracellular traps, caspase-1,cytokines measurement
Assessments with neutrophil extracellular traps be presented in ng/ml; Assessments with caspase-1 and cytokines be presented in pg/ml
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Jan 2016
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, panpinhua, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227107
- Sponsor's protocol ID
- 81470266
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRF-1 Regulate Alveolar Macrophage Pyroptosis in Acute Lung Injury and of Which Will be Possible Mechanism
- ClinicalTrials.gov ID
- NCT03227107
- Acronym / sponsor ID
- 81470266
- Conditions
- ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 24 Jul 2017 (actual)
- 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.
- enrollment criteria and clinical data collection: follow the principles of medical ethics, the development of inclusion and exclusion criteria, select 90 cases of ARDS patients, in the active treatment at the same time, according to the Berlin standard severity of the disease divided into mild group, moderate Group and severe group, according to the prognosis during hospitalization is divided into survival group and death group. BALF specimens were collected on the day of admission to detect the levels of NETs and alveolar macrophages. The acute and chronic health status scoring system Ⅱ (APACHEⅡ) and Murray acute lung injury score, blood routine, creatinine, urea nitrogen, fasting blood glucose, Item, mean arterial pressure, arterial blood gas analysis, oxygenation index; record the patient's mechanical ventilation time and other data;
- Pearson linear correlation analysis of BALF in the content of NETs, alveolar macrophage coke death level was a positive correlation between the Spearman rank correlation analysis BALF in the NETs content and alveolar macrophage coke death level, APACHE Ⅱ, Murray score, creatinine, Urea nitrogen, fasting blood glucose and other indicators and ARDS severity was positively correlated;
- To analyze the prognostic factors of different prognostic factors, to evaluate the content of NETs in BALF, the level of alveolar macrophage coke, APACHEⅡ and Murray scores were analyzed by receiver operator characteristic curve (ROC curve) Short - term survival outcome prognostic value.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with ARDS
Key inclusion criteria (2 listed)
- ARDS patients diagnosis within 3 days
- Over 18 years old but no more than 75 years old
Key exclusion criteria (8 listed)
- Severe thoracic open trauma
- Pulmonary embolism
- Severe cardiovascular and cerebrovascular disease
- Endocrine system diseases
- Coagulation dysfunction
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
neutrophil extracellular traps, caspase-1,cytokines measurement
Time frame: 4 years
Assessments with neutrophil extracellular traps be presented in ng/ml; Assessments with caspase-1 and cytokines be presented in pg/ml
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
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 ARDS, 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 8 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 24 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Haitao, Doctor ((+86)18684916132, 168101013@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neutrophil extracellular traps, caspase-1,cytokines measurement (time frame: 4 years). 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 24 Jul 2017.