2024-516651-41-00招募中3 期
CORTICOP_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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 24
- 主要终点
- Number of ventilator-free days (VFD) and alive.
研究概览
简要总结
To determine if the systemic administration of corticosteroids, as compared to placebo, increases the number of ventilator-free days (VFD) and alive at day 28 in COPD patients admitted to an ICU, a step-up unit or a respiratory care unit for an ACRF requiring ventilatory support, either invasive or non-invasive.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 40 years, man or woman
- •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)
- •Severe acute exacerbation, 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) 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 mechanical ventilation (possibly already started <24H), either invasive or NIV (implemented because of hypercapnic acidosis with PaCO2 ≥ 45 mmHg and pH ≤ 7.35)
- •Admission to an ICU, a step-up unit or a respiratory care unit <24h
- •Written Informed consent from the patient or his surrogates. In patients who are not able to consent on admission (i.e., because of hypercapnic encephalopathy) and in absence of a substitute decision maker, an emergency inclusion procedure will be allowed, with a mandatory delayed consent
- •Affiliation to (or benefit from) French health insurance system.
排除标准
- •Previous diagnostic of asthma, according to "GINA" international guidelines
- •Exclusion period due to other interventional clinical trial enrolment which can influence primary outcome
- •Previous inclusion in the present study.
- •current and proven SARS-COV2 infection
- •Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding
- •underlying disease requiring chronic daily use of systemic steroids
- •Pneumothorax at inclusion
- •Support circulatoire extra-corporel (ECMO or ECCO2R) à la randomisation
- •Moribund patient life expectancy < 3 months
- •Patients protected by law
结局指标
主要结局
Number of ventilator-free days (VFD) and alive.
Number of ventilator-free days (VFD) and alive.
次要结局
- ICU acquired weakness (MRC-score) assessed on day 28 or at the time of ICU discharge
- ICU-acquired infections (especially Ventilator-Associated Pneumonia)
- Length of ICU and hospital stay
- ICU and hospital mortality
- Duration of NIV and of invasive mechanical ventilation
- Circulatory support-free days and alive at day 28
- Severe hyperglycemia requiring intravenous insulin before day 5
- Gastro-intestinal bleeding: acute loss of 2 g/dL of hemoglobin requiring red blood cell transfusion or gastroscopic evaluation
- Uncontrolled arterial hypertension: unusual hypertension requiring to introduce/add antihypertensive medication (compared to usual medications)
- NIV failure rate, defined by intubation
- Day 28 and Day 90 mortality
- Standardized mortality ratio (SMR)
- Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90
- Dyspnea and comfort (patient reported outcome) at Day 90
研究者
project manager
Scientific
Centre Hospitalier De Versailles
研究点 (24)
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