ARDSNCT02174081
ARDS Prediction Score in Critically Ill Patients in China
An observational study of ARDS and Septic Shock, run by Jianfeng Xie at 1 site in China.
Trial summary
ARDS is a severe disease, it's important to predict the incidence of ARDS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS, Septic Shock
- How many people
- 698 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Jun 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients have the risk of ARDS
Who may be able to join
- Critically ill patients who admitted into participating ICU
Who cannot join
- Patients with chronic pulmonary disease such as chronic obstructive pulmonary disease (COPD), asthma, lung cancer, pulmonary fibrosis and tuberculosis Age less than 18 years old Pregnancy Died within 24 hours from ICU admission ARDS patients who diagnosed 24hours before ICU admission Referral from other hospital to participating ICU Lack of data of ARDS risk factors
Trial locations and contacts
1 site in 1 country.
About this study
ARDS is a severe disease, it's important to predict the incidence of ARDS.
Read the detailed description
From January 1 to January 31, 2012 and from January 1 to January 10, 2013 , all patients admit to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded.
- Conditions
- ARDS, Septic Shock
- Keywords
- mechanical ventilation, ARDS, Ventilator strategy, outcome
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of ARDS
evaluate the incidence of risk factors of ARDS
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2016
- Study completionJun 2016
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.
- 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
- Enrolment
- 698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianfeng Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianfeng Xie, Southeast University, China
- Investigators
- Jianfeng Xie, Dr, Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174081
- Sponsor's protocol ID
- ARDS Prediction system
- Status last verified
- Jun 2016
- First submitted
- 11 Jun 2014
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARDS Prediction Score in Critically Ill Patients in China
- ClinicalTrials.gov ID
- NCT02174081
- Acronym / sponsor ID
- ARDS Prediction system
- Conditions
- ARDS, Septic Shock
- Keywords
- mechanical ventilation, ARDS, Ventilator strategy, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- Jianfeng XieUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Jun 2014 (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.
ARDS is a severe disease, it's important to predict the incidence of ARDS.
Detailed description
From January 1 to January 31, 2012 and from January 1 to January 10, 2013 , all patients admit to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients have the risk of ARDS
Key inclusion criteria (1 listed)
- Critically ill patients who admitted into participating ICU
Key exclusion criteria (1 listed)
- Patients with chronic pulmonary disease such as chronic obstructive pulmonary disease (COPD), asthma, lung cancer, pulmonary fibrosis and tuberculosis Age less than 18 years old Pregnancy Died within 24 hours from ICU admission ARDS patients who diagnosed 24hours before ICU admission Referral from other hospital to participating ICU Lack of data of ARDS risk factors
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
incidence of ARDS
Time frame: up to 24 months
evaluate the incidence of risk factors of ARDS
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 28 Jun 2016.
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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.
Jianfeng Xie, Dr principal investigator
Southeast 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 ARDS and Septic Shock, run by Jianfeng Xie 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 1 inclusion and 1 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 28 Jun 2016. 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?
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?
incidence of ARDS (time frame: up to 24 months). 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 28 Jun 2016.