The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Percentage of Hospital mortality
研究概览
简要总结
Cross sectional randomized clinical trial study will be done at Respiratory intensive care unit and Chest department at Assiut University Hospitals on All patients who developed hospital acquired pneumonia including ventilator associated pneumonia through two years duration to assess the prognostic value of different severity scores including (PSI, CURB65, SMART COP, IDSA/ATS and SOAR) in patients with HAP, assess platelet count as a marker for severity, evaluate efficacy and safety of adjuvant systemic steroids in patients with severe conditions and measurement of cortisol level to assess steroid response before administration.
详细描述
The following parameters will be recorded:
- Demographic data: including age, sex, smoking history.
- Clinical data: Glasgow coma scales, Co-morbidities are determined by reviewing the patients' clinical histories, chest examination.
- Vital signs: including body temperature, respiratory rate, heart rate, and arterial blood pressure.
- Oxygenation data: including arterial blood gases in fixed days (at the start, 3rd day and 7th day of steroid administration), ratio of partial oxygen tension in arterial blood to fraction of inspired oxygen (PaO2/FiO2 ratio).
- Laboratory data include complete blood picture focusing on leukocytic count and platelets, kidney and liver function tests, serum electrolytes, Erythrocyte sedimentation rate, C reactive protein, sputum culture and cortisol level before steroid administration.
- Radiology data include chest X-ray and chest ultrasonography at the day of diagnosis and at 7th day of steroid administration. Chest CT will be done if possible.
Procedures: Systemic steroids will be administered early with a dosages equivalent to prednisone 40 mg/day for 7 days which is considered as a "stress dose" of systemic corticosteroids for pneumonia. The patients will also receive the appropriate initial intravenous antibiotic medication and the standard care as recommended in RICU policy. Cortisol level will be measured before steroid administration.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •This study will be conducted on admitted patients aged ≥18 years that developed hospital acquired pneumonia including ventilator associated pneumonia. Its diagnosis is confirmed by developing pneumonia after 48 H of admission and they had new or progressive infiltrates on the chest X-ray with one of the 3 requirements of: fever more than 37.8 C or purulent sputum or leukocytosis.
排除标准
- •Patients having lung cancer and those who hadn't the full data for scoring fulfilled.
- •Chronically immunosuppressed patients (chemotherapy, human immunodeficiency virus infection, or other immunosuppressive agents).
- •Condition requiring prolonged steroid use > 0.5 mg/kg/day of prednisone equivalent.
- •Major gastrointestinal bleeding within 3 months.
- •Patients with prolonged intubation and having tracheostomy.
- •Patients with neurological disorders or encephalopathy.
- •Patients with pandemic H1N1 influenza A pneumonia.
研究组 & 干预措施
prednisone
prednisone 40 mg/day for 7 days
干预措施: Prednisone (Drug)
prednisone
prednisone 40 mg/day for 7 days
干预措施: placebo (Drug)
placebo
5ml saline /day for 7 days
干预措施: Prednisone (Drug)
placebo
5ml saline /day for 7 days
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Hospital mortality
时间窗: 28 days
measure the predicting 28 day mortality for all included cases.
次要结局
- Percentage of ICU needing(28 days)
- Time to clinical stability(28 days)
- complications of hospitalization(28 days)
研究者
Rabab Hamed Hassan
specialist of chest and tuberculosis
Assiut University