Corticosteroids in Community Acquired Pneumonea
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||Corticosteroids and ICU Course of Community Acquired Pneumonia in Egyptian Settings|
- PaO2:FIO2improvement 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.
Active Comparator: 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
Placebo Comparator: Placebo group
This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug).
|Drug: Saline Solution|
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.
- 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;
- 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.
The adopted SOFA score (up to 6 points) was proposed by Vincent et al., . The number of MV-free days was defined as the number of days after ventilation was discontinued up to study day 8. Shock was defined as requirement of vasopressors. ARDS was defined by consensus criteria.
All the patients were subjected to
- Routine laboratory screen, including CBC, RBS, serum urea and creatinine, liver enzymes, serum billirubin and coagulation profiles;
- Chest X ray on at least on admission and at day 8;
- ABG at least once daily to detect PaO2:FIO2;
- CRP daily from day 1 to 8 and
- Evaluation of SOFA score daily