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Corticosteroids in Community Acquired Pneumonea

This study has been completed.
Sponsor:
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT01228110
First received: October 25, 2010
Last updated: NA
Last verified: July 2009
History: No changes posted

October 25, 2010
October 25, 2010
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PaO2:FIO2 [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
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Corticosteroids in Community Acquired Pneumonea
Corticosteroids and ICU Course of Community Acquired Pneumonia in Egyptian Settings

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

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

  1. Routine laboratory screen, including CBC, RBS, serum urea and creatinine, liver enzymes, serum billirubin and coagulation profiles;
  2. Chest X ray on at least on admission and at day 8;
  3. ABG at least once daily to detect PaO2:FIO2;
  4. CRP daily from day 1 to 8 and
  5. Evaluation of SOFA score daily
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Community Acquired Pneumonia
  • Drug: Hydrocortison
  • Drug: Saline Solution
  • 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
    Intervention: Drug: Hydrocortison
  • Placebo Comparator: Placebo group
    This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug).
    Intervention: Drug: Saline Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01228110
06111972
No
Emad El-Din Omar, Cairo University
Cairo University
Not Provided
Not Provided
Cairo University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP