ARDSNCT05166759
Incidence and Clinical Characteristics of Pulmonary Hypertension Secondary to ARDS in the Highland
An observational study of ARDS, run by Southeast University, China at 1 site in China.
Trial summary
The study is conducted in the affiliated hospital of Qinghai University .Patients in the department of Critical Care Medicine and Emergency Intensive Care Unit will be eligible for inclusion if they meet the Berlin criteria.Two researchers assess pulmonary artery pressure and right heart function of patients who are… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS
- What is being tested?
- Doppler ultrasound
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2021to Dec 2022
- How long will I take part?
- 28 Days
- 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: The study is conducted in the affiliated hospital of Qinghai University .Patients in the department of Critical Care Medicine and Emergency Intensive Care Unit will be eligible for inclusion if they meet the Berlin criteria.Two researchers assess pulmonary artery pressure and right heart function of patients who are enrolled.
Who may be able to join
- 18 to 80 years of age Meet the diagnostic criteria Receive invasive mechanical ventilation within 48 hours
- -
Who cannot join
- Patients with those disease will be excluded ： chronic obstructive pulmonary disease Pulmonary embolism Chronic heart failure Idiopathic pulmonary fibrosis Pulmonary hypertension Pregnant women will be excluded too.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of QingHai University
Xining, Qinghai
Chun Pan, MD, 13814009925, panchun1982@gmail.com
About this study
Official title: Incidence and Clinical Characteristics of Pulmonary Hypertension Secondary to ARDS
The study is conducted in the affiliated hospital of Qinghai University .Patients in the department of Critical Care Medicine and Emergency Intensive Care Unit will be eligible for inclusion if they meet the Berlin criteria.Two researchers assess pulmonary artery pressure and right heart function of patients who are enrolled.
- Conditions
- ARDS
- Being tested
- Doppler ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasoundDevice
Pulmonary artery pressure and right heart function will be assessed using Doppler ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pulmonary Hypertension Secondary to ARDS in the Highland
Measured: 20/11/2021-20/12/2022
ICU mortality ICU mortality
Mortality during treatment in ICU
Measured: 20/11/2021-20/12/2022
28-days mortality rate
Mortality at 28 days of hospitalization
Measured: 20/11/2021-20/12/2022
Secondary outcomes (2)
Ventilator time
Ventilator time in ICU
Measured: 20/11/2021-20/12/2022
Hospital length of stay
Total length of stay in hospital
Measured: 20/11/2021-20/12/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start25 Nov 2021
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Qinghai University
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
- Investigators
- Chun Pan, MD, Principal investigator, Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166759
- Sponsor's protocol ID
- ARDS in the highland
- Status last verified
- Nov 2021
- First submitted
- 20 Dec 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhu P, Zhu J, Tong S, She X, Qi Z, Xu Q, Shi Z, Si L, Hou M, Gan G, Pan C. Clinical characteristics of patients with a risk of pulmonary artery hypertension secondary to ARDS in a high-altitude area. BMJ Open Respir Res. 2023 Jul;10(1):e001475. doi: 10.1136/bmjresp-2022-001475.
PubMed 37524522
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Clinical Characteristics of Pulmonary Hypertension Secondary to ARDS
- ClinicalTrials.gov ID
- NCT05166759
- Acronym / sponsor ID
- ARDS in the highland
- Conditions
- ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Qinghai University
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Dec 2021 (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.
The study is conducted in the affiliated hospital of Qinghai University .Patients in the department of Critical Care Medicine and Emergency Intensive Care Unit will be eligible for inclusion if they meet the Berlin criteria.Two researchers assess pulmonary artery pressure and right heart function of patients who are enrolled.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is conducted in the affiliated hospital of Qinghai University .Patients in the department of Critical Care Medicine and Emergency Intensive Care Unit will be eligible for inclusion if they meet the Berlin criteria.Two researchers assess pulmonary artery pressure and right heart function of patients who are enrolled.
Key inclusion criteria (2 listed)
- 18 to 80 years of age Meet the diagnostic criteria Receive invasive mechanical ventilation within 48 hours
- -
Key exclusion criteria (2 listed)
- Patients with those disease will be excluded ： chronic obstructive pulmonary disease Pulmonary embolism Chronic heart failure Idiopathic pulmonary fibrosis Pulmonary hypertension Pregnant women will be excluded too.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler ultrasoundPulmonary artery pressure and right heart function will be assessed using Doppler ultrasound | Device | – |
Primary outcome
Incidence of Pulmonary Hypertension Secondary to ARDS in the Highland
Time frame: 20/11/2021-20/12/2022
ICU mortality ICU mortality
Time frame: 20/11/2021-20/12/2022
Mortality during treatment in ICU
28-days mortality rate
Time frame: 20/11/2021-20/12/2022
Mortality at 28 days of hospitalization
2 secondary outcomes
Ventilator time
Time frame: 20/11/2021-20/12/2022
Hospital length of stay
Time frame: 20/11/2021-20/12/2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Derived from this study: PubMed 37524522Zhu P, Zhu J, Tong S, She X, Qi Z, Xu Q, Shi Z, Si L, Hou M, Gan G, Pan C. Clinical characteristics of patients with a risk of pulmonary artery hypertension secondary to ARDS in a high-altitude area. BMJ Open Respir Res. 2023 Jul;10(1):e001475. doi: 10.1136/bmjresp-2022-001475.
- 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.
Chun Pan, MD principal investigator
Qinghai 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, 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 2 inclusion and 2 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 22 Dec 2021. 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 Chun Pan, MD (13814009925, panchun1982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pulmonary Hypertension Secondary to ARDS in the Highland (time frame: 20/11/2021-20/12/2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05166759, which also lists 1 linked publication.
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 22 Dec 2021.