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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
  Purpose

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 Intervention
Community Acquired Pneumonia
 Drug: Hydrocortison
Drug: Saline Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Corticosteroids and ICU Course of Community Acquired Pneumonia in Egyptian Settings

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia Steroids
U.S. FDA Resources

Further study details as provided by Cairo University:

Primary Outcome Measures:
  • 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.


Enrollment: 80
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Emad El-Din Omar, Cairo University
ClinicalTrials.gov Identifier: NCT01228110     History of Changes
Other Study ID Numbers: 06111972
Study First Received: October 25, 2010
Last Updated: October 25, 2010
Health Authority: Egypt: Institutional Review Board

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
 Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on June 17, 2013