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临床试验/NCT05032898
NCT05032898Unknown不适用

Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II

China-Japan Friendship Hospital0 个研究点目标入组 1,500 人开始时间: 2021年9月最近更新:
适应症

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

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

发起方
China-Japan Friendship Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Wang

Principal investigator

China-Japan Friendship Hospital

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