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Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (TripAE)

2014年8月15日 更新者:Wang Ying、Beijing Chao Yang Hospital
Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of chronic obstructive pulmonary disease is one of the most important causes of death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD exacerbations. In clinical practice for the treatment of acute exacerbation of COPD, antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.

研究概览

地位

未知

详细说明

Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of COPD is one of the most important causes of death in patients with COPD. The global strategy for the diagnosis, management, and prevention of COPD recommends systemic corticosteroids therapy in COPD exacerbations as it can shorten recovery time, reduce treatment failure, improve lung function and arterial hypoxemia. In clinical practice for the treatment of acute exacerbation of COPD, antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.

研究类型

观察性的

注册 (预期的)

400

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease from 1st July, 2014 from Beijing Chao Yang Hospital

描述

Inclusion Criteria:

  • Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease
  • Age≥ 40years old

Exclusion Criteria:

  • The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease
  • Chest radiography shows congestive heart failure
  • Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases
  • Serious cardiac failure, renal insufficiency or hepatic dysfunction

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
change of the score of COPD Assesment Test as a measurement of the overall condition of the patient
大体时间:baseline, 1 month after dischahge, 2 months after discharge
baseline, 1 month after dischahge, 2 months after discharge

次要结果测量

结果测量
大体时间
change of the score of modified Medical British Research Council questionaire as a measurement of the overall condition of the patient
大体时间:baseline, 1 month after discharge, 2 months after discharge
baseline, 1 month after discharge, 2 months after discharge

其他结果措施

结果测量
大体时间
percentage of use of systemic corticosteroid in patients
大体时间:8 months after the first enrollment
8 months after the first enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Wang Ying, Master、Beijing Chao Yang Hospital
  • 学习椅:Huang Kewu, M.D.、Beijing Chao Yang Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年8月1日

初级完成 (预期的)

2015年6月1日

研究完成 (预期的)

2015年9月1日

研究注册日期

首次提交

2014年7月9日

首先提交符合 QC 标准的

2014年8月15日

首次发布 (估计)

2014年8月18日

研究记录更新

最后更新发布 (估计)

2014年8月18日

上次提交的符合 QC 标准的更新

2014年8月15日

最后验证

2014年8月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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