Comparing Hydrocortisone and Prednisolone for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 14
- 主要终点
- Readmission for COPD exacerbation or death from all causes
研究概览
简要总结
The goal of this cluster randomized controlled trial is to determine the optimal treatment for Acute Exacerbation of Chronic Obstructive Pulmonary Disease. The study compares the effects and side effects of hydrocortisone and prednisolone in patients above 40 years old diagnosed with chronic obstructive pulmonary disease with acute exacerbation. The main question is whether there is a difference in readmission for COPD excerbation or all cause mortality within thirty days.
Participants will randomized to receive treatment with either hydrocortisone or prednisolone.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥40 years
- •Chronic obstructive pulmonary disease with acute exacerbation, unspecified: ICDJ44
排除标准
- •All diagnoses that would merit treatment with a specific corticosteroid
- •Pregnant or breastfeeding women
- •Active tuberculosis or invasive fungal infection
研究组 & 干预措施
Treatment with Hydrocortisone.
This arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days.
干预措施: Hydrocortisone (Drug)
Treatment with Methylprednisolone
This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days.
干预措施: Methylprednisolone (drug) (Drug)
结局指标
主要结局
Readmission for COPD exacerbation or death from all causes
时间窗: 30 days
次要结局
- Readmission for COPD exacerbation(90 days)
- Daily amount of insulin administered to the patient by day 7 or discharge from hospital(7 days)
- Gastrointestinal bleeding(30 days)
- Days alive and out of hospital(14 days)
- Mortality(90 days)
- All-cause infections(90 days)
- Need for mechanical ventilation(30 days)
- New onset infections(30 days)
- Blood glucose levels(7 days)