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

Study Overview

• Status: Completed
• Conditions: Community Acquired Pneumonia
• Intervention / Treatment: Drug: Saline Solution; Drug: Hydrocortison

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Hydrocortison
Placebo Comparator: Placebo group; This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug).	Drug: Saline Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Registration Dates

• First Submitted: October 25, 2010
• First Submitted That Met QC Criteria: October 25, 2010
• First Posted (Estimate): October 26, 2010

Study Record Updates

• Last Update Posted (Estimate): October 26, 2010
• Last Update Submitted That Met QC Criteria: October 25, 2010
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: 06111972