ARDS (Acute Respiratory Distress Syndrome)NCT03827863
Acute CorPulmonale and ARDS Circulation Protection China Study China (ACPC)
An observational study of ARDS (Acute Respiratory Distress Syndrome) and Acute Cor Pulmonale, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The investigators established a national cohort of Chinese ARDS with Acute CorPulmonale to enable prospective observational studies. The goals are the following. First, morbidity and mortality rate of ARDS with ACP in the ICU across Chinese mainland. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome), Acute Cor Pulmonale
- What is being tested?
- TTE
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Mar 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the critically patients admitted to ICU
Who may be able to join
- 18≤ aged ≤85 years old
- received a diagnosis of ARDS with Acute CorPulmonal
- provided signed informed consent
Who cannot join
- are diagnosed as cardiogenic pulmonary edema
- are diagnosed as Idiopathic pulmonary fibrosis acute exacerbation
- are participating in other interventional clinical trials
- refused to continue to participate in the study or refused further treatment
- unable to complete the study procedure even if assisted and otherwise unable to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, 100730
Hui Xu, +86 10 69155817, pumchkyc@126.com
Longxiang Su, MD
About this study
Official title: The Prospective Observational Study of ARDS Related Acute CorPulmonale and the Randomized Controlled Study of ARDS Aimed Circulation Protection China (ACPC)
The investigators established a national cohort of Chinese ARDS with Acute CorPulmonale to enable prospective observational studies. The goals are the following.
First, morbidity and mortality rate of ARDS with ACP in the ICU across Chinese mainland.
Second, forming the diagnostic ultrasound strategy of ARDS-ACP, namely TRIP procedures. And predictive value of diagnostic strategy for ACP or prognosis of ACP were calculated.
Third, comparison of ventilator parameters for ACP and non-ACP or survivor and non-survisors, which reaveald that of inappropriate mechanical ventilation on circulation and prognosis. Screening for risk factors of ARDS with ACP.
Read the detailed description
Acute respiratory distress syndrome (ARDS) is an acute and critical illness characterized by progressive dyspnea and refractory hypoxemia caused by intrapulmonary or extrapulmonary factors. The mortality rate of ARDS is extremely high. ACP caused by pulmonary circulatory disorder is its main clinical feature, which is related to the severity of lung injury in ARDS patients. It has been recognized that the ACP is an independent risk factor for the prognosis of patients with ARDS. Positive pressure mechanical ventilation is an important ARDS treatment strategy for ARDS. Especially the lung protective ventilation strategy with "small tidal volume and increased PEEP" as the core content, which achieved a milestone of lower the mortality of ARDS. However, improper use of positive pressure mechanical ventilation can increase right ventricular load and increase mortality in ARDS patients. Therefore, understanding the effect of positive pressure mechanical ventilation on right heart function in patients with ARDS is important for prevention and treatment for the ACP of ARDS and reduction of ARDS mortality.
The alveolar edema, alveolar collapse, and hypoxic pulmonary vasoconstriction loss caused by increased pulmonary vascular permeability and release of inflammatory mediators resulted in loss of ventilation/blood flow, severe hypoxemia, pulmonary vasospasm, pulmonary microthrombus formation, which increased pulmonary arterial pressure and even APC. Positive pressure mechanical ventilation maintains alveolar ventilation through positive airway pressure, prevents premature alveolar collapse by positive end expiratory pressure (PEEP), changes intrathoracic pressure and lung volume, and affects the right ventricle load. Different studies have found that the incidence of ACP in patients with ARDS is from 22% to 60%. Jardin, et al found that patients with ARDS had a significant increase in ACP and mortality when the airway pressure was greater than 26 cmH2O, which revealed that the difference in positive pressure mechanical ventilation settings has a significant difference in the right heart function of ARDS patients. Mekontso, et al propose a simple clinical risk score for early identification of ACP included pneumonia as cause of ARDS, driving pressure ≥18cmH2O, PaO2/FiO2 ratio<150 mmHg, and PaCO2≥48mmHg. However, for the morbidity and mortality of ACP in ARDS, the related risk factors and criteria are different due to the influence of the different etiology of ARDS and the different study time. For these reasons, the investigators established a national cohort of Chinese ARDS with Acute CorPulmonale to enable prospective observational studies.
- Being tested
- TTE
- 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.
TTEDevice
TTE to detect the heart function
| Study group | Role | What they receive |
|---|---|---|
| ARDS WITH ACP | 1. Diagnostic criteria for ARDS ARDS defined as within 1 week of a known clinical insult or new or worsening respiratory symptoms. ARDS was classified as mild (200 mmHg < PaO2/FIO2≤300 mmHg), moderate (100 mmHg < PaO2/FIO2≤200 mmHg) and severe (PaO2/FIO2≤100 mmHg) according to the value of PaO2/FiO2 ratio. Importantly, the PaO2/FiO2 ratio value is considered only with a CPAP or PEEP value of at least 5 cmH2O.
2. Ultrasound diagnostic criteria for ACP The specific diagnostic parameters are as follows: TR>2.8m/s; RVEDA/LVEDA>0.6 or Right ventricle/left ventricle basal diameter ratio>1.0 or systolic D sign; IVC >2cm with decreased inspiratory collapse; Pulmonary Regurgitation Velocity >2.2m/s. Receives: Device: TTE | |
| ARDS WITHOUT ACP | Diagnosis as ARDS but no ultrasound evidence of ACP. Receives: Device: TTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 days SURVIVAL
Measured: 28 days after ICU admission
length of stay of ICU
Measured: 1 years
mechanical ventilation time
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Apr 2019 (estimated)
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Mar 2020 (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 ARDS (Acute Respiratory Distress Syndrome)Studies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827863
- Sponsor's protocol ID
- HS-1615
- Status last verified
- Feb 2019
- First submitted
- 29 Jan 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: When the study begin.
Publications
Su LX, Shang XL, Zhu R, He W, Pan P, Zhang HM, Zhang LN, Liu DW, Yu RG, Wang XT; Chinese Critical Ultrasound Study Group (CCUSG). A cross-sectional study of acute cor pulmonale in acute respiratory distress syndrome patients in China. Chin Med J (Engl). 2019 Dec 5;132(23):2842-2847. doi: 10.1097/CM9.0000000000000531.
PubMed 31856056
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective Observational Study of ARDS Related Acute CorPulmonale and the Randomized Controlled Study of ARDS Aimed Circulation Protection China (ACPC)
- ClinicalTrials.gov ID
- NCT03827863
- Acronym / sponsor ID
- HS-1615
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 4 Feb 2019 (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 investigators established a national cohort of Chinese ARDS with Acute CorPulmonale to enable prospective observational studies. The goals are the following.
First, morbidity and mortality rate of ARDS with ACP in the ICU across Chinese mainland.
Second, forming the diagnostic ultrasound strategy of ARDS-ACP, namely TRIP procedures. And predictive value of diagnostic strategy for ACP or prognosis of ACP were calculated.
Third, comparison of ventilator parameters for ACP and non-ACP or survivor and non-survisors, which reaveald that of inappropriate mechanical ventilation on circulation and prognosis. Screening for risk factors of ARDS with ACP.
Detailed description
Acute respiratory distress syndrome (ARDS) is an acute and critical illness characterized by progressive dyspnea and refractory hypoxemia caused by intrapulmonary or extrapulmonary factors. The mortality rate of ARDS is extremely high. ACP caused by pulmonary circulatory disorder is its main clinical feature, which is related to the severity of lung injury in ARDS patients. It has been recognized that the ACP is an independent risk factor for the prognosis of patients with ARDS. Positive pressure mechanical ventilation is an important ARDS treatment strategy for ARDS. Especially the lung protective ventilation strategy with "small tidal volume and increased PEEP" as the core content, which achieved a milestone of lower the mortality of ARDS. However, improper use of positive pressure mechanical ventilation can increase right ventricular load and increase mortality in ARDS patients. Therefore, understanding the effect of positive pressure mechanical ventilation on right heart function in patients with ARDS is important for prevention and treatment for the ACP of ARDS and reduction of ARDS mortality.
The alveolar edema, alveolar collapse, and hypoxic pulmonary vasoconstriction loss caused by increased pulmonary vascular permeability and release of inflammatory mediators resulted in loss of ventilation/blood flow, severe hypoxemia, pulmonary vasospasm, pulmonary microthrombus formation, which increased pulmonary arterial pressure and even APC. Positive pressure mechanical ventilation maintains alveolar ventilation through positive airway pressure, prevents premature alveolar collapse by positive end expiratory pressure (PEEP), changes intrathoracic pressure and lung volume, and affects the right ventricle load. Different studies have found that the incidence of ACP in patients with ARDS is from 22% to 60%. Jardin, et al found that patients with ARDS had a significant increase in ACP and mortality when the airway pressure was greater than 26 cmH2O, which revealed that the difference in positive pressure mechanical ventilation settings has a significant difference in the right heart function of ARDS patients. Mekontso, et al propose a simple clinical risk score for early identification of ACP included pneumonia as cause of ARDS, driving pressure ≥18cmH2O, PaO2/FiO2 ratio<150 mmHg, and PaCO2≥48mmHg. However, for the morbidity and mortality of ACP in ARDS, the related risk factors and criteria are different due to the influence of the different etiology of ARDS and the different study time. For these reasons, the investigators established a national cohort of Chinese ARDS with Acute CorPulmonale to enable prospective observational studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDS WITH ACP | – | Device: TTE1. Diagnostic criteria for ARDS ARDS defined as within 1 week of a known clinical insult or new or worsening respiratory symptoms. ARDS was classified as mild (200 mmHg < PaO2/FIO2≤300 mmHg), moderate (100 mmHg < PaO2/FIO2≤200 mmHg) and severe (PaO2/FIO2≤100 mmHg) according to the value of PaO2/FiO2 ratio. Importantly, the PaO2/FiO2 ratio value is considered only with a CPAP or PEEP value of at least 5 cmH2O. 2. Ultrasound diagnostic criteria for ACP The specific diagnostic parameters are as follows: TR>2.8m/s; RVEDA/LVEDA>0.6 or Right ventricle/left ventricle basal diameter ratio>1.0 or systolic D sign; IVC >2cm with decreased inspiratory collapse; Pulmonary Regurgitation Velocity >2.2m/s. |
| ARDS WITHOUT ACP | – | Device: TTEDiagnosis as ARDS but no ultrasound evidence of ACP. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the critically patients admitted to ICU
Key inclusion criteria (3 listed)
- 18≤ aged ≤85 years old
- received a diagnosis of ARDS with Acute CorPulmonal
- provided signed informed consent
Key exclusion criteria (5 listed)
- are diagnosed as cardiogenic pulmonary edema
- are diagnosed as Idiopathic pulmonary fibrosis acute exacerbation
- are participating in other interventional clinical trials
- refused to continue to participate in the study or refused further treatment
- unable to complete the study procedure even if assisted and otherwise unable to comply with the study protocol
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 |
|---|---|---|
| TTETTE to detect the heart function | Device | ARDS WITH ACP, ARDS WITHOUT ACP |
Primary outcome
28 days SURVIVAL
Time frame: 28 days after ICU admission
length of stay of ICU
Time frame: 1 years
mechanical ventilation time
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 31856056Su LX, Shang XL, Zhu R, He W, Pan P, Zhang HM, Zhang LN, Liu DW, Yu RG, Wang XT; Chinese Critical Ultrasound Study Group (CCUSG). A cross-sectional study of acute cor pulmonale in acute respiratory distress syndrome patients in China. Chin Med J (Engl). 2019 Dec 5;132(23):2842-2847. doi: 10.1097/CM9.0000000000000531.
- Individual participant dataSharing planned: Undecided. When the study begin.
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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 (Acute Respiratory Distress Syndrome) and Acute Cor Pulmonale, run by Peking Union Medical College Hospital 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 3 inclusion and 5 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 5 Feb 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 days SURVIVAL (time frame: 28 days after ICU admission). 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 NCT03827863, 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 5 Feb 2019.