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

NCT03827863 | Unknown DMC

• 1 other identifier: HS-1615
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS (Acute Respiratory Distress Syndrome); Acute Cor Pulmonale

Outcome Measures

Primary Outcomes (3)

• 28 days SURVIVAL

  28 days after ICU admission

• length of stay of ICU

  1 years

• mechanical ventilation time

  1 years

Study Arms (2)

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

TTE DEVICE

TTE to detect the heart function

ARDS WITH ACP; ARDS WITHOUT ACP

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the critically patients admitted to ICU

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Related Publications (1)

• 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.

  PMID: 31856056 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood specimen, morning blood samples were collected at the baseline assessment and will be collected at the follow-ups. After simple processing, the supernatant was separated after centrifugation and frozen at -80°C at each participating centre, and then transported to the central laboratory by cold chain every 3 months for future use. With these specimens, we intend to explore for novel biomarkers that reflect ARDS progression and develop predictive models to identify a subgroup population among ARDS with ACP who are at high risk. Examples of biomarkers to explore include glycocalyx shedding, vascular endothelium, and inflammatory factors.

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 4, 2019
• Study Start: April 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: March 31, 2020
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

CN (1)