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Status unknownNCT03827863Updated Feb 5, 2019

Acute CorPulmonale and ARDS Circulation Protection China Study China (ACPC)

An observational study in ARDS (Acute Respiratory Distress Syndrome) and Acute Cor Pulmonale, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-02-05.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

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.

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Conditions studied

03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

the critically patients admitted to ICU

Inclusion criteria

  • 18≤ aged ≤85 years old
  • received a diagnosis of ARDS with Acute CorPulmonal
  • provided signed informed consent

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

    Device: TTE

  • ARDS WITHOUT ACP

    Diagnosis as ARDS but no ultrasound evidence of ACP.

    Device: TTE

Interventions

  • DeviceTTE

    TTE to detect the heart function

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What researchers measure

Primary outcomes

  1. 28 days SURVIVAL

    Time frame: 28 days after ICU admission

  2. length of stay of ICU

    Time frame: 1 years

  3. mechanical ventilation time

    Time frame: 1 years

07

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, 100730, China
    • Hui Xu · Contact · pumchkyc@126.com · +86 10 69155817
    • Longxiang Su, MD · Principal investigator
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided — When the study begin.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03827863
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Feb 4, 2019
Start date
Apr 1, 2019 (estimated)
Primary completion
Jan 31, 2020 (estimated)
Completion
Mar 31, 2020 (estimated)
Last update
Feb 5, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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