Corticosteroids in Community Acquired Pneumonea

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT01228110

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Community Acquired Pneumonia	Drug: Hydrocortison Drug: Saline Solution	N/A

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Corticosteroids and ICU Course of Community Acquired Pneumonia in Egyptian Settings

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01228110

Other Study ID Numbers:

06111972

First Posted:

Oct 26, 2010

Last Update Posted:

Oct 26, 2010

Last Verified:

Jul 1, 2009

Additional relevant MeSH terms:

Pneumonia

Hydrocortisone

Study Results

No Results Posted as of Oct 26, 2010