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Corticosteroids in Community Acquired Pneumonea

Primary Purpose

Community Acquired Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hydrocortison
Saline Solution
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community Acquired Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Corticosteroid group

    Placebo group

    Arm Description

    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

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

    Outcomes

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 25, 2010
    Last Updated
    October 25, 2010
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01228110
    Brief Title
    Corticosteroids in Community Acquired Pneumonea
    Official Title
    Corticosteroids and ICU Course of Community Acquired Pneumonia in Egyptian Settings
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. 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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Community Acquired Pneumonia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Corticosteroid group
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug).
    Intervention Type
    Drug
    Intervention Name(s)
    Hydrocortison
    Intervention Type
    Drug
    Intervention Name(s)
    Saline Solution
    Primary Outcome Measure Information:
    Title
    PaO2:FIO2
    Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

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    Corticosteroids in Community Acquired Pneumonea

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