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临床试验/NCT05734365
NCT05734365
招募中
不适用

Epidemiological, Clinical and Biological Characteristics and Therapeutic Management of ICU Patients With Severe Acute Exacerbation of COPD. Evaluation of the Prognosis and the Factors Associated With Survival Multicentre Prospective Observational Register

Versailles Hospital1 个研究点 分布在 1 个国家目标入组 500 人2022年11月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
COPD Exacerbation Acute
发起方
Versailles Hospital
入组人数
500
试验地点
1
主要终点
Day 90 survival
状态
招募中
最后更新
3年前

概览

简要总结

COPD is one of the leading causes of morbidity, mortality and health care utilisation worldwide. Currently, COPD is the third leading cause of death worldwide and is therefore a major public health problem. Projections show an increase in the prevalence and burden of COPD in the coming decades due to ageing populations and continued exposure to risk factors.

In patients with COPD, mortality due to exacerbations is about 35%. Exacerbations represent the most important respiratory event in the history of this chronic disease and are of major socio-economic interest (about 50-75% of healthcare expenditure in this disease).

In the most severe cases, COPD exacerbations lead to respiratory distress with hypercapnic ventilatory acidosis requiring ventilatory support. These most severe episodes are common, accounting for 20% of exacerbations and are a signal of advanced disease, with a high risk of future hospitalisations and a limited long-term prognosis.

Despite progress in management, the mortality of these severe acute exacerbations is around 15% in the ICU and 20% in hospital. The long-term prognosis following hospitalisation for an acute exacerbation of COPD is poor with a 5-year mortality of around 50%. On the one hand, the means and treatments likely to improve the prognosis of these patients are of great medical and socio-economic interest, on the other hand, it seems important to identify the elements that may be associated with management failure and to treat them where appropriate.

Thus, improving scientific knowledge thanks to prospective data, evaluating the different characteristics and prognosis of patients hospitalised for a severe acute exacerbation of COPD seems, in the 21st century, a major axis in order to continue to optimise the individual management of these patients but also collectively, given the COPD public health burden.

注册库
clinicaltrials.gov
开始日期
2022年11月1日
结束日期
2027年12月
最后更新
3年前
研究类型
Observational
性别
All

研究者

发起方
Versailles Hospital
责任方
Principal Investigator
主要研究者

Alexis FERRE

Medical doctor, Principal investigator

Versailles Hospital

入排标准

入选标准

  • Age ≥ 40 years old
  • COPD documented or strongly suspected
  • Chronic respiratory symptoms (dyspnoea, cough and/or sputum)
  • Exposure to a known risk factor for COPD (such as tobacco smoke)
  • If available, respiratory function tests showing non- or partially reversible obstructive syndrome (post-bronchodilator ratio FEV1/CV \< 0.7)
  • Severe acute exacerbation, defined as a worsening of the patient's usual respiratory symptoms with signs of acute respiratory distress (polypnoea ≥ 30 cycles.min-1 or use of accessory respiratory muscles) and/or hypercapnic acidosis (with PaCO2 ≥ 45 mmHg and pH ≤ 7.35)
  • Admission to an ICU, or a dedicated respiratory intensive care unit

排除标准

  • Known asthma (according to the criteria of the international "Global Initiative for Asthma" guidelines)
  • Patient refusal to participate (information note, application for non-opposition)

结局指标

主要结局

Day 90 survival

时间窗: 90 days after ICU admission

vital status at day 90

ICU survival

时间窗: immediately after hospitalization in ICU

vital status at ICU discharge

次要结局

  • One-year survival(one year after ICU admission)
  • Factors associated with ICU mortality(immediately after hospitalization in ICU)
  • Factors associated with hospital mortality(immediately after hospital discharge)
  • Factors associated with the need for invasive mechanical ventilation(immediately after the intervention named invasive mechanical ventilation)

研究点 (1)

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