Corticosteroids in Community Acquired Pneumonea
Primary Purpose
Community Acquired Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hydrocortison
Saline Solution
Sponsored by
About this trial
This is an interventional treatment trial for Community Acquired Pneumonia
Eligibility Criteria
Inclusion Criteria:
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
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Corticosteroid group
Placebo group
Arm Description
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
This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01228110
Brief Title
Corticosteroids in Community Acquired Pneumonea
Official Title
Corticosteroids and ICU Course of Community Acquired Pneumonia in Egyptian Settings
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
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.
The adopted SOFA score (up to 6 points) was proposed by Vincent et al., [21]. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corticosteroid group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug).
Intervention Type
Drug
Intervention Name(s)
Hydrocortison
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Primary Outcome Measure Information:
Title
PaO2:FIO2
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
12. IPD Sharing Statement
Learn more about this trial
Corticosteroids in Community Acquired Pneumonea
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