Acute Respiratory Distress SyndromeNCT02490215
Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs
An observational study of Acute Respiratory Distress Syndrome, run by Peking Union Medical College Hospital at 26 sites in China.
Trial summary
The acute respiratory distress syndrome(ARDS)has a high morbidity and mortality in patients admitted to intensive care units(ICUs). It represents a significant public health issue. No large nationwide, multicenters study of ARDS has been conducted in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 2,530 participants
- Where
- 26 sitesChina
- Study dates
- Jan 2015to Dec 2015
- 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: All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 )
Who may be able to join
- all patients age >18 yrs admitted to 24 participating ICUs
Who cannot join
- No patients should be excluded (regardless of age, underlying disease, life expectancy, etc).
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
MICU, Peking union medical college hospital
Beijing, Beijing Municipality, 100730
Beijing Hospital of ministry of Health
Beijing, Beijing Municipality
Department of Critical Care Medicine, Fuxing Hospital, Capital Medical University
Beijing, Beijing Municipality
General ICU, Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
China-Japan Friendship Hospital
Beijng, Beijing Municipality
Department of Critical Care Medicine, The Second Hospital of Jilin University
Changchun, Jilin
Department of Critical Care Medicine, Xiangya Hospital, Central South University
Changsha, Hunan
Department of Critical Care Medicine, West China Hospital, Sichuan University
Chengdu, Sichuan
Department of Emergency and Intensive Care Medicine, The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Department of CriticalCare Medicine, Guangdong General Hospital
Guangzhou, Guangdong
Department of Critical Care Medicine, Hainan Provincial People's Hospital
Haikou, Hainan
Department of Critical Care Medicine, Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Department of Critical Care Medicine, The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Department of Critical Care Medicine, The Affiliated Hopsital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Department of Critical Care Medicine, Qilu Hospital of Shandong University
Jinan, Shandong
Department of Emergency Medicine and Medical ICU, The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Emergency ICU, Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
Department of Critical Care Medicine, The First Affiliated Hospital of China Medical University
Shenyang, Liaoning
Department of Critical Care Medicine, Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei
Department of Critical Care Medicine, First Affiliated Hospital, Xinjiang Medical University
Ürümqi, Xinjiang
Department of Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei
Surgical Intensive Care Unit, Xijing Hospital
XiAn, Shanxi
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
ICU, The First Affiliated Hospital, Zhengzhou University
Zhengzhou, Henan
About this study
The acute respiratory distress syndrome(ARDS)has a high morbidity and mortality in patients admitted to intensive care units(ICUs). It represents a significant public health issue. No large nationwide, multicenters study of ARDS has been conducted in China. The purposes of this study are to analyse: 1)the incidence and outcomes of ARDS in ICU; 2) factors associated the mortality ; and 3) risk factors for development of ARDS .
Read the detailed description
All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 ) will be screened at ICU admission and daily for the occurrence of ARDS ( AECC criteria) for a maximum of 28 days after ICU admission.
Data collection:
- For all patients, Demographic characteristics, admission category, the patient source intervention during ICU , APACHEII , SOFA score and discharge information will be collected
- For patients with ARDS, data about ABG , parameters of MV, hemodynamic on day0 to day7 and last day of MV will be collected.
- For patients without ARDS at ICU admission, data about risk factor for ARDS ,such as LIPS score, parameters of MV , and fluid balance on ICU day0 to day7 will be collected.
- Conditions
- Acute Respiratory Distress Syndrome
- 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 |
|---|---|---|
| ARDS, non-ARDS | patients with ARDS and patients without ARDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of acute respiratory distress syndrome (ARDS)
incidence of ARDS = the number of patients developing ARDS during ICU / the total number of patients admitted to ICU
Measured: from ICU admission to 28-day of ICU stay
Secondary outcomes (2)
ICU mortality of patients with ARDS
Measured: followed up to 3 months after inclusion or to ICU discharge, whichever occurred first
hospital mortality of patients with ARDS
Measured: followed up to 3 months after inclusion or to hospital discharge, whichever occurred first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 2,530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin Du, Principal investigator, MICU of Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490215
- Sponsor's protocol ID
- MICU2015_1
- Status last verified
- Jan 2015
- First submitted
- 18 May 2015
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs
- ClinicalTrials.gov ID
- NCT02490215
- Acronym / sponsor ID
- MICU2015_1
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,530 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Jul 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 acute respiratory distress syndrome(ARDS)has a high morbidity and mortality in patients admitted to intensive care units(ICUs). It represents a significant public health issue. No large nationwide, multicenters study of ARDS has been conducted in China. The purposes of this study are to analyse: 1)the incidence and outcomes of ARDS in ICU; 2) factors associated the mortality ; and 3) risk factors for development of ARDS .
Detailed description
All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 ) will be screened at ICU admission and daily for the occurrence of ARDS ( AECC criteria) for a maximum of 28 days after ICU admission.
Data collection:
- For all patients, Demographic characteristics, admission category, the patient source intervention during ICU , APACHEII , SOFA score and discharge information will be collected
- For patients with ARDS, data about ABG , parameters of MV, hemodynamic on day0 to day7 and last day of MV will be collected.
- For patients without ARDS at ICU admission, data about risk factor for ARDS ,such as LIPS score, parameters of MV , and fluid balance on ICU day0 to day7 will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS, non-ARDS | – | –patients with ARDS and patients without ARDS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 )
Key inclusion criteria (1 listed)
- all patients age >18 yrs admitted to 24 participating ICUs
Key exclusion criteria (1 listed)
- No patients should be excluded (regardless of age, underlying disease, life expectancy, etc).
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 acute respiratory distress syndrome (ARDS)
Time frame: from ICU admission to 28-day of ICU stay
incidence of ARDS = the number of patients developing ARDS during ICU / the total number of patients admitted to ICU
2 secondary outcomes
ICU mortality of patients with ARDS
Time frame: followed up to 3 months after inclusion or to ICU discharge, whichever occurred first
hospital mortality of patients with ARDS
Time frame: followed up to 3 months after inclusion or to hospital discharge, whichever occurred first
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 16 Jun 2020.
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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.
Bin Du principal investigator
MICU of Peking Union Medical College Hospital
26 sites 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 Peking Union Medical College Hospital at 26 sites 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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 acute respiratory distress syndrome (ARDS) (time frame: from ICU admission to 28-day of ICU stay). 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 16 Jun 2020.