NCT Number: NCT01228110
Corticosteroids in Community Acquired Pneumonea
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
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Saline Solution
DrugPrimary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Cairo University
Other
Registry information
Official study title
Corticosteroids and ICU Course of Community Acquired Pneumonia in Egyptian Settings
Important dates
- First posted
- Oct 26, 2010
- Registry last updated
- Oct 26, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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