Corticosteroids in Community Acquired Pneumonea

NCT ID: NCT01228110

Last Updated: 2010-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL

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

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

Conditions

Community Acquired Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Hydrocortison

Intervention Type: DRUG

Placebo group

This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug).

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: DRUG

Interventions

Hydrocortison

Intervention Type: DRUG

Saline Solution

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Cairo University

Other Identifiers

06111972

Identifier Type: -

Identifier Source: org_study_id