Corticosteroids in Community Acquired Pneumonea

Community Acquired Pneumonia Clinical Trial

Official title:

Corticosteroids and ICU Course of Community Acquired Pneumonia in Egyptian Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228110
• Other study ID #: 06111972
• Status: Completed
• Phase: N/A
• First received: October 25, 2010
• Last updated: October 25, 2010

Study information

• Verified date: July 2009
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Intervention

Drug:
• Hydrocortison

• Saline Solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No