Clinical trial NCT03827863: Acute CorPulmonale and ARDS Circulation Protection China Study China (ACPC)
Official title: The Prospective Observational Study of ARDS Related Acute CorPulmonale and the Randomized Controlled Study of ARDS Aimed Circulation Protection China (ACPC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS (Acute Respiratory Distress Syndrome)
Acute Cor Pulmonale
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the critically patients admitted to ICU

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: 28 days SURVIVAL
timeFrame: 28 days after ICU admission
measure: length of stay of ICU
timeFrame: 1 years
measure: mechanical ventilation time
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
citation: 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.