ArdsNCT05493839
A Reverification of the Berlin Definition Plateau Criteria in Golmud
An observational study of Ards, run by Southeast University, China at 1 site in China.
Trial summary
This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, Golmud People's Hospital from January 2015 to june 2022 were divided into three groups: mild (142mmHg < PaO2/ FiO2 ≤ 213 mmHg), moderate (71mmHg < PaO2/ FiO2 ≤… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ards
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2022to 30 Aug 2022
- 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: This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, Golmud People's Hospital from January 2015 to june 2022 were divided into three groups: mild (142mmHg < PaO2/ FiO2 ≤ 213 mmHg), moderate (71mmHg < PaO2/ FiO2 ≤ 142mmHg) and severe (PaO2/ FiO2 ≤ 71 mmHg).
Who may be able to join
- Meet the diagnostic criteria of ARDS
Who cannot join
- length of stay in hospital less than 48h Data missing younger than 18 years or older than 80 years
Trial locations and contacts
1 site in 1 country.
About this study
This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, Golmud People's Hospital from January 2015 to june 2022 were divided into three groups: mild (142mmHg < PaO2/ FiO2 ≤ 213 mmHg), moderate (71mmHg < PaO2/ FiO2 ≤ 142mmHg) and severe (PaO2/ FiO2 ≤ 71 mmHg). The ICU mortality, 28-day mortality, non-ventilator time in ICU, ICU hospitalization time observed respectively.
- Conditions
- Ards
- Medical subject headings
- Acute Lung Injury
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 |
|---|---|---|
| Plateau Criteria | mild ： 142mmHg < PaO2/ FiO2 ≤ 213 mmHg moderate ： 71mmHg < PaO2/ FiO2 ≤ 142mmHg severe： PaO2/ FiO2 ≤ 71 mmHg | |
| Berlin Definition | mild ： 200mmHg < PaO2/ FiO2 ≤ 300 mmHg moderate ： 100mmHg < PaO2/ FiO2 ≤ 200mmHg severe： PaO2/ FiO2 ≤ 100 mmHg | |
| zhang | ARDS：PaO2/FiO2≤100mmHg ALI ：100mmHg<PaO2/FiO2≤150mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Mortality during treatment in ICU
Measured: up to 24 weeks
28-days mortality rate
28-days mortality rate [ Time Frame: 28 days after discharge ] Mortality at 28 days of hospitalization
Measured: up to 24 weeks
Secondary outcomes (3)
Ventilator Free time
Ventilator Free time in ICU
Measured: up to 24 weeks
Ventilator time
Ventilator time in ICU
Measured: up to 24 weeks
Hospital length of stay
Hospital length of stay in hospital
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start20 Jun 2022
- Primary completion8 Aug 2022
- Study completion30 Aug 2022 (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.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493839
- Sponsor's protocol ID
- ARDS in Golmud
- Status last verified
- Aug 2022
- First submitted
- 7 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reverification of the Berlin Definition Plateau Criteria in Golmud
- ClinicalTrials.gov ID
- NCT05493839
- Acronym / sponsor ID
- ARDS in Golmud
- Conditions
- Ards
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 9 Aug 2022 (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.
This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, Golmud People's Hospital from January 2015 to june 2022 were divided into three groups: mild (142mmHg < PaO2/ FiO2 ≤ 213 mmHg), moderate (71mmHg < PaO2/ FiO2 ≤ 142mmHg) and severe (PaO2/ FiO2 ≤ 71 mmHg). The ICU mortality, 28-day mortality, non-ventilator time in ICU, ICU hospitalization time observed respectively.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Plateau Criteria | – | –mild ： 142mmHg < PaO2/ FiO2 ≤ 213 mmHg moderate ： 71mmHg < PaO2/ FiO2 ≤ 142mmHg severe： PaO2/ FiO2 ≤ 71 mmHg |
| Berlin Definition | – | –mild ： 200mmHg < PaO2/ FiO2 ≤ 300 mmHg moderate ： 100mmHg < PaO2/ FiO2 ≤ 200mmHg severe： PaO2/ FiO2 ≤ 100 mmHg |
| zhang | – | –ARDS：PaO2/FiO2≤100mmHg ALI ：100mmHg<PaO2/FiO2≤150mmHg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, Golmud People's Hospital from January 2015 to june 2022 were divided into three groups: mild (142mmHg < PaO2/ FiO2 ≤ 213 mmHg), moderate (71mmHg < PaO2/ FiO2 ≤ 142mmHg) and severe (PaO2/ FiO2 ≤ 71 mmHg).
Key inclusion criteria (1 listed)
- Meet the diagnostic criteria of ARDS
Key exclusion criteria (1 listed)
- length of stay in hospital less than 48h Data missing younger than 18 years or older than 80 years
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
ICU mortality
Time frame: up to 24 weeks
Mortality during treatment in ICU
28-days mortality rate
Time frame: up to 24 weeks
28-days mortality rate [ Time Frame: 28 days after discharge ] Mortality at 28 days of hospitalization
3 secondary outcomes
Ventilator Free time
Time frame: up to 24 weeks
Ventilator time
Time frame: up to 24 weeks
Hospital length of stay
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
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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.
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 Southeast University, China 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: status not confirmed, as of the sponsor's last update on 9 Aug 2022. 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?
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?
ICU mortality (time frame: up to 24 weeks). 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 9 Aug 2022.