Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 主要终点
- All-cause in-hospital mortality
研究概览
简要总结
The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China.
详细描述
Objective
The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China.
Eligibility Criteria: Details are shown in the Eligibility Criteria part.
Procedures and Measurements: At admission, each eligible subject will be given an in-depth interview to collect the demographics, smoking history, medical history, management of disease during stable period, etc. During hospitalization, treatment and auxiliary examination results including laboratory and lung function tests will be recorded if available. To ensure the quality and uniformity of spirometry data, training on performing spirometry will be provided to each study site by professional doctors from central site. At discharge, physicians will record the discharge diagnoses and clinical outcomes including death, intensive care unit admission, chronic obstructive pulmonary disease assessment test (CAT) score and total direct cost for each participant. During follow-ups, clinical outcomes including death and exacerbation events, change of medication, new-developed complications, auxiliary examination results, and economic burden will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •hospitalized with main diagnosis of acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
排除标准
- •refusing to sign informed consent forms
- •participating in clinical trials or intervention studies of drugs
- •diagnosed as active pulmonary tuberculosis, or acute left heart failure
结局指标
主要结局
All-cause in-hospital mortality
时间窗: From date of admission to date of discharge, an expected median of 10 days
All-cause mortality during hospitalization
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 30 days after discharge
时间窗: 30 days after day of discharge
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 30 days after discharge
次要结局
- Time to the first readmission due to acute exacerbation of chronic obstructive pulmonary disease(30 days, 1 year after day of discharge)
- Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 1 year after discharge(1 year after day of discharge)
- Post-bronchodilator forced vital capacity (L)(30 days, 1 year after day of discharge)
- All-cause mortality(30 days and 1 year after day of discharge)
- Chronic obstructive pulmonary disease assessment test (CAT) score(At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge)
- Modified medical research council (mMRC) dyspnea scale(At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge)
- Post-bronchodilator forced expiratory volume in one second (L)(30 days, 1 year after day of discharge)
- Predicted post-bronchodilator forced expiratory volume in one second (%)(30 days, 1 year after day of discharge)
- Post-bronchodilator forced expiratory volume in one second to forced vital capacity(30 days, 1 year after day of discharge)
- Direct total cost of chronic obstructive pulmonary disease management(At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge)
研究者
Chen Wang
Principal investigator
China-Japan Friendship Hospital
