Comparison of corticosteroids versus placebo on duration of ventilatory support during severe acute exacerbations of COPD patients in the intensive care unit: a multicentre randomized controlled trial, CORTICOP. - CORTICOP

Centre Hospitalier de Versailles0 个研究点目标入组 440 人2019年6月26日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Severe acute exacerbations of Chronic Obstructive Pulmonary Disease
发起方: Centre Hospitalier de Versailles
入组人数: 440
状态: 进行中（未招募）
最后更新: 4年前

暂无简介。

注册库

who.int

开始日期

2019年6月26日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•1\) Patients aged \= 40 years, man or woman
•2\) Strongly suspected or documented COPD defined by all the following criterias :
•\- Persistent respiratory symptoms (dyspnoea, chronic cough or sputum production)
•\- History of exposure to a risk factor such as tobacco smoke
•\- If available, pulmonary function tests showing airflow limitation that is not fully reversible (post\-bronchodilator ratio of forced expiratory volume in 1 s (FEV1\)/forced vital capacity (FVC) ratio \< 0\.7\)
•3\) ACRF, defined by the presence of the two following criteria:
•\- COPD exacerbation defined by a change in the patient baseline respiratory symptoms: dyspnoea, cough or sputum (volume or purulence) for at least 24 hours and requiring a change in regular respiratory medication
•\- Acute respiratory failure (defined by clinical signs of excessive muscle activity: polypnea \= 30 breaths /min or use of accessory respiratory muscles) requiring ventilatory support, either invasive (implemented because of respiratory distress) or NIV (implemented because of hypercapnic acidosis with PaCO2 \= 45 mmHg and pH \= 7\.35\)
•\- Acute respiratory failure \< 24h
•4\) Admission to an ICU, a step\-up unit or a respiratory care unit

•Patient will not be included if they present any of the following criteria
•1\) Previous diagnostic of asthma, according to GINA” international guidelines
•2\) Recent use of systemic corticosteroids, defined by systemic corticosteroids use in the past 7 days
•3\) Contra\-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro\-intestinal ulcer bleeding
•4\) Pneumothorax at randomization
•5\) Extracorporeal life support (ECMO or ECCO2R) at randomization
•6\) Moribund patient life expectancy \< 3 months
•7\) Pregnancy
•8\) Patients protected by law
•9\) Exclusion period due to other clinical trial enrolment which can influence primary outcome