A Realworld Study of Acute Respiratory Distress Syndrome in China (CHARDSnet)

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.

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Distress Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Huang Xu; Phone Number: 8613641345816; Email: huangxu1122@sina.com
• Study Contact Backup: Name: Zhan Qingyuan; Phone Number: 8613911785957; Email: dr.zhanqy@gmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China - Japan Friendship Hospital
      • Contact: Huang Xu; Phone Number: 8613641345816; Email: huangxu1122@sina.com
      • Contact: Zhan Qingyuan; Phone Number: 8613911785957; Email: dr.zhanqy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This research plans to enroll 400 hospitalized patients (≥ 18 years old with main diagnosis as ARDS). Sample size estimation is based on estimated mortality of ARDS hospitalized patients (~5%). Study patients will be recruited from 20 hospitals across China,each hospital will recruit 20 patients. Hospital selection follows a multi-stage sampling strategy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	the 28days mortality after the diagnosis of ARDS	28days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU stay	The days between admission to intensive care unit(ICU) and discharge from ICU.	90 days
Ventilation free days	The days between successful weaning from mechanical ventilation and day 28 after study enrollment.	28 days
Incidence of ARDS	The total number of acute respiratory distress syndrome(ARDS)patients in 2 years.	2 years
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
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
Number of patients using adjuvant drugs	Adjuvant drugs refer to corticosteroid, sedative, analgesic and non depolarizing muscle relaxant.	28 days
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
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
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
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
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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Peking University First Hospital; Peking Union Medical College Hospital; Qilu Hospital of Shandong University; Ruijin Hospital; Beijing Chao Yang Hospital; Beijing Hospital; The Second Affiliated Hospital of Chongqing Medical University; First Affiliated Hospital of Xinjiang Medical University; Fujian Provincial Hospital; PLA General Hospital; Xiangya No.2 Hospital of Central South University; Xiangya No.1 Hospital of Central South University; First Hospital Affiliated to China Medical University; Nanjing General Hospital; Third Hospital Affiliated to Neimenggu Medical University; Second Hospital Affiliated to Hebei Medical University; First Hospital Affiliated to Anhui Medical University; No.3 Hospital of Peking University; Fuxing Hospital

Publications and helpful links

General Publications

• Huang X, Zhang R, Fan G, Wu D, Lu H, Wang D, Deng W, Sun T, Xing L, Liu S, Wang S, Cai Y, Tian Y, Zhang Y, Xia J, Zhan Q; CHARDSnet group. Incidence and outcomes of acute respiratory distress syndrome in intensive care units of mainland China: a multicentre prospective longitudinal study. Crit Care. 2020 Aug 20;24(1):515. doi: 10.1186/s13054-020-03112-0.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Estimate): November 29, 2016
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: prognosis; epidemiology; clinical features; Acute Respiratory Distress Syndrome; management
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: CHARDS20160301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided