Corticosteroids and ICU Course of Community Acquired Pneumonia in Egyptian Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- PaO2:FIO2
研究概览
简要总结
Low dose hydrocortisone IV in patients with CAP fastens recovery of pneumonia and prevents the development of sepsis related complications with a significant reduction in duration of mechanical ventilation
详细描述
Inclusion Criteria Minor criteria includes
- respiratory rate > 30 bpm at admission;
- ratio of PaO2 to fraction of inspired oxygen (PaO2:FIO2 ) < 250;
- chest radiograph showing bilateral involvement or multilobar involvement;
- systolic blood pressure < 90 mm Hg; or
- diastolic blood pressure < 60 mm Hg. Major criteria includes
- Requirement of MV;
- Increase in the size of opacities on chest radiograph of 50% or more at 48 hours;
- Requirement of vasopressors for more than 4 hours; or
- Serum creatinine 2 mg/dl or more.
Exclusion criteria:
- Children;
- Nosocomial pneumonia;
- Hospitalisation within the previous 14 days;
- Severe immunosuppression (chronic use of systemic steroids);
- Non-steroid immunosuppressive treatment or HIV);
- Chronic chest disease; , tuberculosis, aspiration or obstructive pneumonia;
- Congestive heart failure (cerebrovascular stroke);
- Chronic renal or hepatic disease;
- Acute burn injury;
- Malignancy;
- Pregnancy; and
- Major gastrointestinal bleed within 3 months of the current hospitalization
Study Outcome The end-points of the study were improvement in PaO2:FIO2 (PaO2:FIO2 > 300 or ≥100 increase from study entry) and sepsis related organ failure assessment, (SOFA) score by day 8 and the development of delayed septic shock.
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
- 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
- •Minor criteria included
- •respiratory rate > 30 bpm at admission;
- •ratio of PaO2 to fraction of inspired oxygen (PaO2:FIO2 ) < 250;
- •chest radiograph showing bilateral involvement or multilobar involvement;
- •systolic blood pressure < 90 mm Hg; or
- •diastolic blood pressure < 60 mm Hg. Major criteria included
- •Requirement of MV;
- •Increase in the size of opacities on chest radiograph of 50% or more at 48 hours;
- •Requirement of vasopressors for more than 4 hours; or
- •Serum creatinine 2 mg/dl or more. 10
排除标准
- •Children;
- •Nosocomial pneumonia;
- •Hospitalisation within the previous 14 days;
- •Severe immunosuppression (chronic use of systemic steroids);
- •Non-steroid immunosuppressive treatment or HIV);
- •Chronic chest disease; , tuberculosis, aspiration or obstructive pneumonia;
- •Congestive heart failure (cerebrovascular stroke);
- •Chronic renal or hepatic disease;
- •Acute burn injury;
- •Malignancy;
- •Pregnancy; and
- •Major gastrointestinal bleed within 3 months of the current hospitalization.
研究组 & 干预措施
Corticosteroid group
This group was entitled to receive hydrocortisone 200 mg loading bolus followed by an intravenous infusion (300 mg in 500 ml 0.9% saline) at a rate of 12.5 mg/hour for 7 days
干预措施: Hydrocortison (Drug)
Placebo group
This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug).
干预措施: Saline Solution (Drug)
结局指标
主要结局
PaO2:FIO2
improvement in PaO2:FIO2 (PaO2:FIO2 \> 300 or ≥100 increase from study entry) and sepsis related organ failure assessment, (SOFA) score by day 8 and the development of delayed septic shock.
次要结局
未报告次要终点