Dexamethasone Infusion in Community-acquired Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- length of hospital stay
研究概览
简要总结
The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.
详细描述
Community-acquired pneumonia (CAP) is common and approximately 20 percent of all episodes of pneumonia result in hospitalization. It is the leading cause of community-acquired infection requiring ICU admission.1 Especially elderly patients may have a severe illness with a high morbidity and mortality rate. In pulmonary infections, the release of cytokines and other inflammatory mediators from alveolar macrophages serves as a useful mechanism in the elimination of invading pathogens. However, this natural reaction can be potentially harmful when excessive release of circulating inflammatory cytokines causes damage to the patient, particularly the lung.
Interest in the role of corticosteroids in the pathophysiology of critical illness has existed since the early part of the 20th century. On ICU, early treatment with corticosteroids to attenuate systemic inflammation is widespread. At the same time, outside the ICU little evidence is available on the effect of treatment with corticosteroids in patients diagnosed with CAP. Hypothetically, early initiated administration of corticosteroids in the course of a CAP can lower systemic and pulmonary inflammation. This may lead to earlier resolution of pneumonia and a reduction of complications (sepsis, mortality).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 100 years with a community-acquired pneumonia.
- •Criteria to determine a community-acquired pneumonia:
- •Chest radiograph showing new opacities
- •In combination with two of the following findings:
- •Production of sputum
- •Temp >38,0 °C or <36,0 °C
- •Audible abnormalities by chest examination compatible with pneumonia
- •Leukocytosis (>10.000 cells/mm3), leftward shift (>10%) or leukopenia (<4000 cells/mm3)
- •CRP > 15 mg/dl (three times upper limit of normal)
排除标准
- •o The following groups are excluded:
- •Immunocompromised patients:
- •Patients with a known congenital or achieved immunodeficiency.
- •Patients who received chemotherapy less than 6 weeks ago.
- •Patients who received corticosteroids in the last 6 weeks.
- •Patients who received immunosuppressive medication in the last 6 weeks. (like cyclosporine, cyclofosfamide, azathioprine)
- •Patients with COPD who are on systemic corticosteroids for COPD.
- •Patients who require ICU treatment.
研究组 & 干预措施
1
dexamethasone
干预措施: dexamethasone (Drug)
2
Placebo
干预措施: dexamethasone (Drug)
结局指标
主要结局
length of hospital stay
时间窗: 30 days
次要结局
- side-effects inflammation markers lung function(30 days)
