A Realworld Study of Acute Respiratory Distress Syndrome in China

Acute Respiratory Distress Syndrome Clinical Trial

— CHARDSnet  

Official title:

A Realworld Study of Acute Respiratory Distress Syndrome in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02975908
• Other study ID #: CHARDS20160301
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2016
• Last updated: November 23, 2016
• Start date: August 2015
• Est. completion date: February 2019

Study information

• Verified date: November 2016
• Source: China-Japan Friendship Hospital
• Contact: Huang Xu
• Phone: 8613641345816
• Email: huangxu1122[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

ARDS is a critical respiratory disease caused by endogenous and exogenous factors. The mortality of ARDS varies from 30 to 70%. In 2012, a new international diagnostic criterion has been put forward. Yet, its feasibility, reliability and validity need to be tested. Meanwhile, the correlation of different severity and prognosis remains unclear. As so far, the epidemiological information about ARDS in China is lacking.

Investigators plan to conduct a multi-center observational study（real-life study） to investigate the risk factors, morbidity, management and prognosis of ARDS in China, in order to facilitate standardization of diagnosis and management of ARDS and provide basic data and idea for further clinical intervention studies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• =18 years of age; hospitalized patients with main diagnosis as ARDS.

Exclusion Criteria:

• <18 years of age

• Patients or their families refused to participate in the study

• Patients diagnosed as COPD, pulmonary fibrosis or bronchiectasis

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
China	China - Japan Friendship Hospital	Beijing	Beijing

Sponsors (20)

Lead Sponsor

Collaborator

China-Japan Friendship Hospital

Beijing Chao Yang Hospital, Beijing Hospital, First Hospital Affiliated to Anhui Medical University, First Hospital Affiliated to China Medical University, First Hospital Affiliated to Xinjiang Medical University, Fujian Provincial Hospital, Fuxing Hospital, Nanjing General Hospital, No.3 Hospital of Peking University, Peking Union Medical College Hospital, Peking University First Hospital, PLA General Hospital, Qilu Hospital, Ruijin Hospital, Second Hospital Affiliated to Hebei Medical University, The Second Affiliated Hospital of Chongqing Medical University, Third Hospital Affiliated to Neimenggu Medical University, Xiangya No.1 Hospital of Central South University, Xiangya No.2 Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	the 28days mortality after the diagnosis of ARDS	28days	No
Secondary	Length of ICU stay	The days between admission to intensive care unit(ICU) and discharge from ICU.	90 days	No
Secondary	Ventilation free days	The days between successful weaning from mechanical ventilation and day 28 after study enrollment.	28 days	No
Secondary	Incidence of ARDS	The total number of acute respiratory distress syndrome(ARDS)patients in 2 years.	2 years	No
Secondary	Severity of patients	Number of patients in each grade of severities according to Berlin definition: the number of mild, moderate and severe acute respiratory distress syndrome(ARDS) patients will be recorded.	2 years	No
Secondary	Adverse events related to treatment	Number of patients with adverse events, include biotrauma, worsen of hemodynamics, hospital-acquired infection, patient-ventilator asynchrony, gastric distention, aspiration etc.	90 days	No
Secondary	Number of patients using adjuvant drugs	Adjuvant drugs refer to corticosteroid, sedative, analgesic and non depolarizing muscle relaxant.	28 days	No
Secondary	Number of patients with high risk factors	High risk factors for acute respiratory distress syndrome(ARDS), including endogenous factors as pneumonia, aspiration, lung contusion and drowning; the exogenous factors as extrapulmonary trauma, extra pulmonary sepsis , hypovolemic shock, pancreatitis, severe burning, drug overdose, blood transfusion,eclampsia etc.	1 week	No
Secondary	Number of patients with conventional respiratory support techniques	Conventional respiratory support techniques include noninvasive positive pressure ventilation(NPPV), invasive positive pressure ventilation(include volume-controlled ventilation and pressure-controlled ventilation) .	28 days	No
Secondary	Number of patients with unconventional respiratory support techniques	Unconventional respiratory support techniques include recruitment maneuver(RM), prone position ventilation(PPV), high-frequency oscillatory ventilation(HFOV) ,extracorporeal membrane oxygenation(ECMO) and extracorporeal CO2 removal(ECCO2R)	28 days	No
Secondary	Number of patients with impaired lung function	The number patients with impaired lung function 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).	90 days, 1 year	No
Secondary	Number of patients with abnormal lung CT	The number patients with abnormal lung CT 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).	90 days, 1 year	No