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

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.

Study Overview

• Status: Unknown
• Conditions: ARDS (Acute Respiratory Distress Syndrome); Acute Cor Pulmonale
• Intervention / Treatment: Device: TTE

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

the critically patients admitted to ICU

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ARDS WITH ACP; 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.; 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; TTE to detect the heart function
ARDS WITHOUT ACP; Diagnosis as ARDS but no ultrasound evidence of ACP.	Device: TTE; TTE to detect the heart function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
28 days SURVIVAL	28 days after ICU admission
length of stay of ICU	1 years
mechanical ventilation time	1 years

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): January 31, 2020
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pulmonary Heart Disease
• Other Study ID Numbers: HS-1615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: When the study begin.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No