A Prospective Randomized Trial of Systemic Corticosteroids (Oral Prednisolone) in Severe Exacerbation of COPD Requiring Ventilatory Assistance
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 317
- 试验地点
- 1
- 主要终点
- ICU mortality rate
研究概览
简要总结
Evaluation of systematic administration of oral prednisolone (1mg/Kg/day) as an add on therapy in Chronic Obstructive Pulmonary Disease (COPD) patients admitted to intensive care unit (ICU) for severe exacerbation of COPD. Patients with pneumonia are excluded.
Randomization is stratified according to ventilatory support: non invasive or conventional ventilation.The major outcome is the ICU mortality rate in overall population and stratified according to ventilatory mode (noninvasive ventilation (NIV) versus conventional).
Secondary outcomes are superinfection necessitating a new antibiotic course, Length of mechanical ventilation (MV) (and ventilatory free days), Length of ICU stay, The frequency of gastric bleeding episodes that of frequency of hyperglycemic episodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All COPD patients (according to the ATS definition) experiencing acute exacerbation originating in acute respiratory failure and requiring ICU admission will be included in the study.
- •COPD exacerbation is defined by the increased frequency of cough, volume and purulence of sputum and that of wheeze.
- •Acute respiratory failure is defined by the presence of hypercapnia with PaCO2 >45mmHg associated with pH > 7.35 and signs of respiratory muscle fatigue (contraction of accessory respiratory muscles, thoracoabdominal swinging ,..).
排除标准
- •Asthmatic patients defined by a reversible obstructive disease following nebulized bronchodilators,
- •Patients with uncontrolled left heart failure,
- •AECOPD patients with a radiologically documented pneumonia,
- •Systemic corticotherapy within 30 days before screening,
- •contra-indication to corticosteroids (active gastroduodenal ulcer, uncontrolled sepsis, etc. ..)
研究组 & 干预措施
usual care
干预措施: usual care (Drug)
Prednisolone
1mg/kg/day prednisolone for the entire ICU stay and a maximum of 10 days
干预措施: Prednisolone (Drug)
结局指标
主要结局
ICU mortality rate
时间窗: ICU stay (on average patients will be followed 30 days)
次要结局
- Length of MV (and ventilatory free days)(ICU stay (on average patients will be followed 30 days))
研究者
Fekri Abroug
ead of the ICU
Hôpital Universitaire Fattouma Bourguiba